Clincosm LogoSign in Get a demo

Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent Asthma

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01555151
Collaborator
(none)
739
Enrollment
165
Locations
4
Arms
12
Duration (Months)
4.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy, safety and pharmacokinetics of Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and adolescent patients with persistent asthma.

Condition or Disease Intervention/Treatment Phase
  • Drug: Mometasone furoate
  • Device: Concept 1
  • Device: Twisthaler
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
739 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Double-dummy, 4-week Treatment, Parallel-group Study to Evaluate the Efficacy and Safety of Two Doses of Mometasone Furoate Delivered Via Concept1 or Twisthaler® in Adult and Adolescent Patients With Persistent Asthma
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mometasone furoate 80 μg

Description: Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 80 ug delivered via the Concept1 device for 4 weeks.

Drug: Mometasone furoate
Mometasone furoate (MF) 80 µg once daily delivered via Concept1 device; MF 200 μg once daily delivered via Concept1 device; MF 320μg once daily delivered via Twisthaler® device or 800 μg once daily delivered via Twisthaler® device
Other Names:
  • QMF149

    • Device: Concept 1
    A single dose dry powder inhaler (SDDPI)
    Experimental: Mometasone furoate 200 µg

    Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 200 ug delivered via the Twisthaler® device for 4 weeks.

    Drug: Mometasone furoate
    Mometasone furoate (MF) 80 µg once daily delivered via Concept1 device; MF 200 μg once daily delivered via Concept1 device; MF 320μg once daily delivered via Twisthaler® device or 800 μg once daily delivered via Twisthaler® device
    Other Names:
  • QMF149

    • Device: Twisthaler
    A single dose dry powder inhaler (SDDPI)
    Experimental: Mometasone furoate 320 µg

    Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 320 ug delivered via the Concept1 device for 4 weeks.

    Drug: Mometasone furoate
    Mometasone furoate (MF) 80 µg once daily delivered via Concept1 device; MF 200 μg once daily delivered via Concept1 device; MF 320μg once daily delivered via Twisthaler® device or 800 μg once daily delivered via Twisthaler® device
    Other Names:
  • QMF149

    • Device: Concept 1
    A single dose dry powder inhaler (SDDPI)
    Experimental: Mometasone furoate 800 µg

    Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 800 ug delivered via the Twisthaler® device for 4 weeks.

    Drug: Mometasone furoate
    Mometasone furoate (MF) 80 µg once daily delivered via Concept1 device; MF 200 μg once daily delivered via Concept1 device; MF 320μg once daily delivered via Twisthaler® device or 800 μg once daily delivered via Twisthaler® device
    Other Names:
  • QMF149

    • Device: Twisthaler
    A single dose dry powder inhaler (SDDPI)

    Outcome Measures

    Primary Outcome Measures

    1. Trough Forced Expiratory Volume in 1 Second (FEV1) [Day 29]

      Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.

    Secondary Outcome Measures

    1. Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment [Days 8, 15 and 22]

      Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on days 8, 15 and 22 after treatment. Data within 6 hr of rescue medication use is excluded from this analysis.

    2. Forced Vital Capacity (FVC) at All Time Points [Days 1, 8, 15, 22, 28 and 29 at all time points]

      Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data within 6 hr of rescue medication use is excluded from this analysis. Mixed model: FVC = treatment + gender+ baseline FVC + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.

    3. Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points [Days 1, 8, 15, 22, 28 and 29 at all time points]

      The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.

    4. Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points [Days 1, 8, 15, 22, 28 and 29 at all time points]

      Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. Data within 6 hr of rescue medication use is excluded from this analysis.

    5. Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment [Baseline and week 4]

      Peak expiratory flow rate (PEFR) was measured via electronice Peak flow meter by patient at home. Mixed model used: change from baseline in the mean evening PEFR = treatment + age + gender + baseline evening PEFR + level of asthma control + region + center (region)+ error. Center is included as a random effect nested within region.

    6. Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit [Baseline, days 8,15,22 and 29]

      Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ-5 has five questions of the asthma symptoms to be answered by the patient. The overall score is the average of the 5 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. - Baseline ACQ-5 is defined as the questionnaire completed on Day 1 (randomization).

    7. Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment [Baseline and 4 weeks]

      Rescue medication data recorded during the 14 day run-in period is used to calculate the baseline. - Total number of puffs of rescue medication per day over the full 4 weeks is calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the subject. - MIXED model: Change = treatment + gender + baseline mean daily number of puffs + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.

    8. Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment [4 weeks]

      Mixed model used: percentage of days with no rescue medication use = treatment + age + gender + baseline percentage of days with no rescue use + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. A day with no rescue use is defined from diary data as any day where the subject does not use any puffs of rescue medication. The total number of days with no rescue use over the 4 week treatment period is divided by the total number of evaluable days in order to derive the percentage of days with no rescue use.

    9. Fractional Exhaled Nitric Oxide (FeNO) [Days 15 and 29]

      FeNO is widely accepted as a non-invasive marker for airway inflammation such as asthma and conducted according to published guideline. FeNO was measured on days 15 and 29 after treatment.

    10. Plasma Cortisol Concentrations [Baseline, days 1 and 28]

      Blood samples were taken from each subject participating in the study post dose at day 1 and week 4. Cortisol concentrations were evaluated. Results are presented as nmol/L

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Males or females who were ≥ 12 years old at the time informed consent was obtained

    • Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally met the following criteria

    • Patients who were receiving ICS treatment up to the maximum dose per day as indicated in the corresponding package leaflet and also a stable ICS regimen for at least 4 weeks prior to screening (Visit 2).

    • Patients whose level of asthma control according to GINA 2010 guideline was "Partly Controlled" or "Uncontrolled" at screening (Visit 2).

    • Patients with a pre-bronchodilator FEV1 value of ≤ 80% of predicted normal value at screening (Visit 2).

    • Patients who demonstrated an increase of ≥ 12% and 200 mL in FEV1 over prebronchodilator value within 30 minutes after inhalation of 400 μg of salbutamol (360 μg of albuterol) at Visit 2 or between Visit 2 and Visit 5.

    • Patients who were confirmed as "ICS sensitive" by ACQ-5 and FEV1 at Visit 5.

    Key exclusion criteria included:

    • Patients diagnosed with COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease, updated 2010.

    • Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active), or clinically significant bronchiectasis.

    • Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) or chronic lung diseases, which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.

    • Patients with seasonal allergy which is likely to deteriorate his/her asthma condition during the study period judged by the investigator.

    • Patients who have had a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).

    • Patients who have had an emergency room visit for an asthma attack/exacerbation within 4 weeks prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).

    • Patients who have ever required intubation for a severe asthma attack/exacerbation.

    • Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1, or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).

    Other protocol-defined inclusion/exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Kortrijk Belgium 8500
    2 Novartis Investigative Site Liège Belgium 4000
    3 Novartis Investigative Site Niagara Falls Ontario Canada L2G 1J4
    4 Novartis Investigative Site Windsor Ontario Canada N8X 5A6
    5 Novartis Investigative Site Mirabel Quebec Canada J7J 2K8
    6 Novartis Investigative Site Montreal Quebec Canada H3G 1L5
    7 Novartis Investigative Site Trois-Rivières Quebec Canada G8T 7A1
    8 Novartis Investigative Site Quebec Canada GIV 4M6
    9 Novartis Investigative Site Kohtla-Järve Estonia 30321
    10 Novartis Investigative Site Tallinn Estonia 10138
    11 Novartis Investigative Site Tartu Estonia 51014
    12 Novartis Investigative Site Berlin Germany 10117
    13 Novartis Investigative Site Berlin Germany 10696
    14 Novartis Investigative Site Berlin Germany 10717
    15 Novartis Investigative Site Berlin Germany 12203
    16 Novartis Investigative Site Berlin Germany 14050
    17 Novartis Investigative Site Berlin Germany 14057
    18 Novartis Investigative Site Dresden Germany 01069
    19 Novartis Investigative Site Essen Germany 45355
    20 Novartis Investigative Site Goch Germany 47574
    21 Novartis Investigative Site Hamburg Germany 20253
    22 Novartis Investigative Site Hamburg Germany 22143
    23 Novartis Investigative Site Hannover Germany 30317
    24 Novartis Investigative Site Leipzig Germany 4207
    25 Novartis Investigative Site Luebeck Germany 23562
    26 Novartis Investigative Site Muenchen Germany 80539
    27 Novartis Investigative Site Reinfeld Germany 23858
    28 Novartis Investigative Site Schwerin Germany 19055
    29 Novartis Investigative Site Baja Hungary 6500
    30 Novartis Investigative Site Balassagyarmat Hungary 2660
    31 Novartis Investigative Site Budapest Hungary 1033
    32 Novartis Investigative Site Budapest Hungary 1036
    33 Novartis Investigative Site Budapest Hungary 1041
    34 Novartis Investigative Site Budapest Hungary 1121
    35 Novartis Investigative Site Budapest Hungary 1122
    36 Novartis Investigative Site Budapest Hungary 1135
    37 Novartis Investigative Site Cegled Hungary 2700
    38 Novartis Investigative Site Debrecen Hungary 4031
    39 Novartis Investigative Site Godollo Hungary 2100
    40 Novartis Investigative Site Gyor Hungary 9024
    41 Novartis Investigative Site Gyula Hungary 5700
    42 Novartis Investigative Site Kistelek Hungary 6760
    43 Novartis Investigative Site Komarom Hungary 2900
    44 Novartis Investigative Site Makó Hungary 6900
    45 Novartis Investigative Site Mohacs Hungary 7700
    46 Novartis Investigative Site Monor Hungary 2200
    47 Novartis Investigative Site Mosonmagyarovar Hungary 9200
    48 Novartis Investigative Site Nagykanizsa Hungary 8800
    49 Novartis Investigative Site Nyiregyhaza Hungary 4400
    50 Novartis Investigative Site Szeged Hungary 6722
    51 Novartis Investigative Site Szikszo Hungary 3800
    52 Novartis Investigative Site Szombathely Hungary 9700
    53 Novartis Investigative Site Százhalombatta Hungary 2440
    54 Novartis Investigative Site Torokbalint Hungary 2045
    55 Novartis Investigative Site Bangalore Karnataka India 560 010
    56 Novartis Investigative Site Bangalore Karnataka India 560043
    57 Novartis Investigative Site Bangalore Karnataka India 560054
    58 Novartis Investigative Site Mysore Karnataka India 570004
    59 Novartis Investigative Site Pune Maharashtra India 411 014
    60 Novartis Investigative Site Coimbatore Tamil Nadu India 641 045.
    61 Novartis Investigative Site Vellore Tamil Nadu India 632 004
    62 Novartis Investigative Site Jaipur India 302001
    63 Novartis Investigative Site Karamsad India 388225
    64 Novartis Investigative Site Ludhiana India 141001
    65 Novartis Investigative Site Nagpur India 400012
    66 Novartis Investigative Site Thrissur India 680002
    67 Novartis Investigative Site Toon-shi Ehime Japan 791-0281
    68 Novartis Investigative Site Mizunami-city Gifu Japan 509-6134
    69 Novartis Investigative Site Fukuyama-shi Hiroshima Japan 720-0001
    70 Novartis Investigative Site Kitahiroshima-shi Hokkaido Japan 061-1121
    71 Novartis Investigative Site Obihiro-shi Hokkaido Japan 080-0013
    72 Novartis Investigative Site Obihiro-shi Hokkaido Japan 080-0805
    73 Novartis Investigative Site Sapporo-shi Hokkaido Japan 004-0022
    74 Novartis Investigative Site Sapporo-shi Hokkaido Japan 065-0025
    75 Novartis Investigative Site Tomakomai Hokkaido Japan 053-8506
    76 Novartis Investigative Site Kobe-shi Hyogo Japan 653-0021
    77 Novartis Investigative Site Kawasaki-shi Kanagawa Japan 211-0041
    78 Novartis Investigative Site Kurashiki-city Okayama Japan 712-8064
    79 Novartis Investigative Site Kurashiki-shi Okayama Japan 713-8103
    80 Novartis Investigative Site Osaka-city Osaka Japan 530-0001
    81 Novartis Investigative Site Sakai-city Osaka Japan 591-8555
    82 Novartis Investigative Site Suita Osaka Japan 565-0853
    83 Novartis Investigative Site Toyonaka-city Osaka Japan 560-0082
    84 Novartis Investigative Site Chiyoda-ku Tokyo Japan 102-0083
    85 Novartis Investigative Site Chuo-ku Tokyo Japan 103-0027
    86 Novartis Investigative Site Chuo-ku Tokyo Japan 103-0028
    87 Novartis Investigative Site Hachioji-city Tokyo Japan 192-0032
    88 Novartis Investigative Site Shinagawa-ku Tokyo Japan 140-0011
    89 Novartis Investigative Site Tachikawa Tokyo Japan 190-0013
    90 Novartis Investigative Site Toshima-ku Tokyo Japan 171-0014
    91 Novartis Investigative Site Rezekne LV Latvia LV-4600
    92 Novartis Investigative Site Riga LV Latvia 1002
    93 Novartis Investigative Site Talsi LV Latvia LV3201
    94 Novartis Investigative Site Riga Latvia 1002
    95 Novartis Investigative Site Riga Latvia LV-1004
    96 Novartis Investigative Site Riga Latvia LV-1038
    97 Novartis Investigative Site Kaunas LT Lithuania 44320
    98 Novartis Investigative Site Klaipeda LT Lithuania 92288
    99 Novartis Investigative Site Kaunas Lithuania 50009
    100 Novartis Investigative Site Klaipeda Lithuania LT-92231
    101 Novartis Investigative Site Vilnius Lithuania LT-08661
    102 Novartis Investigative Site Kuching Sarawak Malaysia 93586
    103 Novartis Investigative Site Kota Kinabalu Malaysia 88586
    104 Novartis Investigative Site Kuala Lumpur Malaysia 59100
    105 Novartis Investigative Site Almere The Netherlands Netherlands 1311 RL
    106 Novartis Investigative Site Eindhoven The Netherlands Netherlands 5616GB
    107 Novartis Investigative Site Leiderdorp The Netherlands Netherlands 2352 RA
    108 Novartis Investigative Site Rotterdam The Netherlands Netherlands 3021 HC
    109 Novartis Investigative Site Zoetermeer The Netherlands Netherlands 2724 EK
    110 Novartis Investigative Site Geleen Netherlands 6166 GR
    111 Novartis Investigative Site Hoofddorp Netherlands 2134 TM
    112 Novartis Investigative Site Bialystok Poland 15-445
    113 Novartis Investigative Site Gdansk Poland 80-952
    114 Novartis Investigative Site Katowice Poland 40-954
    115 Novartis Investigative Site Krakow Poland 30-510
    116 Novartis Investigative Site Krakow Poland 31-637
    117 Novartis Investigative Site Lodz Poland 95-100
    118 Novartis Investigative Site Poznan Poland 60-693
    119 Novartis Investigative Site Skierniewice Poland 96-100
    120 Novartis Investigative Site Warszawa Poland 01-868
    121 Novartis Investigative Site Wroclaw Poland 50-445
    122 Novartis Investigative Site St. Petersburg Nizhny Novgorod Russian Federation 194356
    123 Novartis Investigative Site Ekaterinburg Russia Russian Federation 620109
    124 Novartis Investigative Site Kazan Russia Russian Federation 420012
    125 Novartis Investigative Site Moscow Russia Russian Federation 109240
    126 Novartis Investigative Site Sankt-Peterburg Russia Russian Federation 197022
    127 Novartis Investigative Site St. Petersburg Russia Russian Federation 194044
    128 Novartis Investigative Site Yaroslavl Russian Federation 150003
    129 Novartis Investigative Site Bojnice Slovak Republic Slovakia 972 01
    130 Novartis Investigative Site Bratislava Slovak Republic Slovakia 831 03
    131 Novartis Investigative Site Bratislava Slovak Republic Slovakia 83101
    132 Novartis Investigative Site Kosice Slovak Republic Slovakia 040 01
    133 Novartis Investigative Site Levice Slovak republic Slovakia 934 01
    134 Novartis Investigative Site Liptovsky Hradok Slovak Republic Slovakia 033 01
    135 Novartis Investigative Site Nitra Slovak Republic Slovakia 949 01
    136 Novartis Investigative Site Roznava Slovak Republic Slovakia 4801
    137 Novartis Investigative Site Surany Slovak Republic Slovakia 942 01
    138 Novartis Investigative Site Trencin Slovak Republic Slovakia 91108
    139 Novartis Investigative Site Bratislava Slovakia 833 40
    140 Novartis Investigative Site Martin Slovakia 036 59
    141 Novartis Investigative Site Poprad Slovakia 05845
    142 Novartis Investigative Site Ruzomberok Slovakia 034 26
    143 Novartis Investigative Site Muang Thailand 11000
    144 Novartis Investigative Site Muang Thailand 30000
    145 Novartis Investigative Site Rajathevee Thailand 10400
    146 Novartis Investigative Site Ratchathewi Thailand 10400
    147 Novartis Investigative Site Adana Turkey 01330
    148 Novartis Investigative Site Bursa Turkey 16059
    149 Novartis Investigative Site Gaziantep Turkey 27310
    150 Novartis Investigative Site Istanbul Turkey 35100
    151 Novartis Investigative Site Izmir Turkey 34890
    152 Novartis Investigative Site Izmir Turkey 35040
    153 Novartis Investigative Site Talas / Kayseri Turkey 38039
    154 Novartis Investigative Site Dnipropetrovsk Ukraine 49066
    155 Novartis Investigative Site Dnipropetrovsk Ukraine 49074
    156 Novartis Investigative Site Donetsk Ukraine 83003
    157 Novartis Investigative Site Kharkiv Ukraine 61039
    158 Novartis Investigative Site Kharkiv Ukraine 61098
    159 Novartis Investigative Site Kharkiv Ukraine 61124
    160 Novartis Investigative Site Kyiv Ukraine 04050
    161 Novartis Investigative Site Kyiv Ukraine 1004
    162 Novartis Investigative Site Kyiv Ukraine 3680
    163 Novartis Investigative Site Kyiv Ukraine 4050
    164 Novartis Investigative Site Vinnytsia Ukraine 20129
    165 Novartis Investigative Site Vinnytsia Ukraine 21029

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01555151
    Other Study ID Numbers:
    • CQMF149E2201
    • 2011-005100-14
    First Posted:
    Mar 15, 2012
    Last Update Posted:
    May 1, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Novartis Pharmaceuticals
    Asthma
    Additional relevant MeSH terms:
    Asthma
    Mometasone Furoate

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone Furoate 800 ug Via the Twisthaler® Device
    Arm/Group Description Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
    Period Title: Overall Study
    STARTED 188 181 184 186
    Safety Set (SAF) 186 180 183 186
    COMPLETED 175 173 178 176
    NOT COMPLETED 13 8 6 10

    Baseline Characteristics

    Arm/Group Title Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone Furoate 800 ug Via the Twisthaler® Device Total
    Arm/Group Description Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening Total of all reporting groups
    Overall Participants 188 181 184 186 739
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    44.4
    (16.33)
    45.9
    (15.56)
    46.0
    (16.18)
    45.5
    (16.57)
    45.4
    (16.15)
    Sex: Female, Male (Count of Participants)
    Female
    98
    52.1%
    94
    51.9%
    113
    61.4%
    97
    52.2%
    402
    54.4%
    Male
    90
    47.9%
    87
    48.1%
    71
    38.6%
    89
    47.8%
    337
    45.6%

    Outcome Measures

    1. Primary Outcome
    Title Trough Forced Expiratory Volume in 1 Second (FEV1)
    Description Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.
    Time Frame Day 29

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
    Arm/Group Title Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone Furoate 800 ug Via the Twisthaler® Device
    Arm/Group Description Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
    Measure Participants 171 165 172 173
    Least Squares Mean (Standard Error) [Liters]
    2.139
    (0.0281)
    2.071
    (0.0283)
    2.187
    (0.0281)
    2.162
    (0.0279)
    2. Secondary Outcome
    Title Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment
    Description Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on days 8, 15 and 22 after treatment. Data within 6 hr of rescue medication use is excluded from this analysis.
    Time Frame Days 8, 15 and 22

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
    Arm/Group Title Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone Furoate 800 ug Via the Twisthaler® Device
    Arm/Group Description Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
    Measure Participants 179 173 181 181
    Day 8 (n=178,173,181,181)
    2.069
    (0.0252)
    2.057
    (0.0253)
    2.113
    (0.0251)
    2.111
    (0.0250)
    Day 15 (n=179,171,177,178)
    2.095
    (0.0254)
    2.048
    (0.0258)
    2.134
    (0.0257)
    2.135
    (0.0255)
    Day 22 (n=174,170,177,177)
    2.126
    (0.0284)
    2.071
    (0.0286)
    2.175
    (0.0283)
    2.146
    (0.0282)
    3. Secondary Outcome
    Title Forced Vital Capacity (FVC) at All Time Points
    Description Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data within 6 hr of rescue medication use is excluded from this analysis. Mixed model: FVC = treatment + gender+ baseline FVC + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.
    Time Frame Days 1, 8, 15, 22, 28 and 29 at all time points

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
    Arm/Group Title Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone Furoate 800 ug Via the Twisthaler® Device
    Arm/Group Description Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
    Measure Participants 178 172 179 174
    Day 1/30 min post-dose (n=172,172,175,173)
    2.892
    (0.0208)
    2.893
    (0.0207)
    2.861
    (0.0209)
    2.897
    (0.0208)
    Day 1/1 hr post-dose (n=178,169,174,175)
    2.930
    (0.0234)
    2.913
    (0.0238)
    2.943
    (0.0238)
    2.946
    (0.0235)
    Day 8/50 min pre-dose (n=174,171,179,174)
    3.111
    (0.0325)
    3.096
    (0.0325)
    3.134
    (0.0321)
    3.139
    (0.0324)
    Day 8/15 min pre-dose (n=176,172,179,174)
    3.099
    (0.0324)
    3.074
    (0.0324)
    3.121
    (0.0321)
    3.125
    (0.0323)
    Day 15 /50 min pre-dose (n=175,169,170,169)
    3.134
    (0.0342)
    3.090
    (0.0347)
    3.168
    (0.0348)
    3.155
    (0.0348)
    Day 15/15 min pre-dose (n=176,168,176,167)
    3.109
    (0.0343)
    3.076
    (0.0348)
    3.137
    (0.0345)
    3.127
    (0.0348)
    Day 22/50 min pre-dose (n=172,167,174,169)
    3.136
    (0.0356)
    3.091
    (0.0359)
    3.203
    (0.0355)
    3.152
    (0.0357)
    Day 22/15 min pre-dose (n=169,170,174,172)
    3.134
    (0.0365)
    3.096
    (0.0363)
    3.198
    (0.0362)
    3.157
    (0.0361)
    Day 28/50 min pre-dose (n=172,168,176,172)
    3.146
    (0.0342)
    3.115
    (0.0345)
    3.184
    (0.0340)
    3.180
    (0.0342)
    Day 28/15 min pre-dose (n=170,165,174, 170)
    3.135
    (0.0345)
    3.095
    (0.0348)
    3.153
    (0.0343)
    3.161
    (0.0344)
    Day 28/30 min post-dose (n=175,166,174,170)
    3.132
    (0.0341)
    3.092
    (0.0346)
    3.151
    (0.0343)
    3.184
    (0.0343)
    Day 28/30 min post-dose (n=173,167,172,172)
    3.140
    (0.0351)
    3.084
    (0.0353)
    3.158
    (0.0353)
    3.161
    (0.0350)
    Day 29/23hr 10 min post-dose (n=173,162,172,168)
    3.160
    (0.0342)
    3.113
    (0.0348)
    3.216
    (0.0343)
    3.194
    (0.0344)
    Day 29/23hr 45 min post-dose (n=172,161, 175,170)
    3.165
    (0.0355)
    3.090
    (0.0363)
    3.192
    (0.0353)
    3.158
    (0.0355)
    4. Secondary Outcome
    Title Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points
    Description The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.
    Time Frame Days 1, 8, 15, 22, 28 and 29 at all time points

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
    Arm/Group Title Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone Furoate 800 ug Via the Twisthaler® Device
    Arm/Group Description Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
    Measure Participants 178 172 179 174
    Day 1/30 min post-dose (n=172,172,175,172)
    1.308
    (0.0181)
    1.300
    (0.0182)
    1.309
    (0.0182)
    1.308
    (0.0182)
    Day 1/1 hr post-dose (n=178,169,174,174)
    1.337
    (0.0197)
    1.327
    (0.0201)
    1.316
    (0.0201)
    1.345
    (0.0199)
    Day 8/50 min pre-dose (n=173,171,179,174)
    1.457
    (0.0323)
    1.449
    (0.0322)
    1.519
    (0.0317)
    1.525
    (0.0321)
    Day 8/15 min pre-dose (n=175,172,179,173)
    1.458
    (0.0329)
    1.466
    (0.0328)
    1.542
    (0.0325)
    1.566
    (0.0328)
    Day 15 /50 min pre-dose (n=175,169,170,169)
    1.509
    (0.0317)
    1.430
    (0.0321)
    1.514
    (0.0320)
    1.544
    (0.0321)
    Day 15/15 min pre-dose (n=175,168,176,167)
    1.494
    (0.0322)
    1.414
    (0.0326)
    1.520
    (0.0321)
    1.561
    (0.0327)
    Day 22/50 min pre-dose (n=171,167,174,169)
    1.511
    (0.0350)
    1.440
    (0.0353)
    1.565
    (0.0348)
    1.555
    (0.0351)
    Day 22/15 min pre-dose (n=168,170,174,172)
    1.540
    (0.0365)
    1.476
    (0.0362)
    1.600
    (0.0361)
    1.591
    (0.0361)
    Day 28/50 min pre-dose (n=171,168,176,172)
    1.504
    (0.0353)
    1.458
    (0.0354)
    1.581
    (0.0350)
    1.598
    (0.0351)
    Day 28/15 min pre-dose (n=169,165,174, 170)
    1.529
    (0.0357)
    1.481
    (0.0359)
    1.574
    (0.0354)
    1.584
    (0.0355)
    Day 28/30 min post-dose (n=175,166,174,170)
    1.558
    (0.0362)
    1.457
    (0.0368)
    1.557
    (0.0364)
    1.615
    (0.0364)
    Day 28/30 min post-dose (n=172,167,172,172)
    1.566
    (0.0367)
    1.460
    (0.0369)
    1.577
    (0.0368)
    1.593
    (0.0365)
    Day 29/23hr 10 min post-dose (n=172,162,172,168)
    1.537
    (0.0369)
    1.451
    (0.0376)
    1.604
    (0.0369)
    1.584
    (0.0371)
    Day 29/23hr 45 min post-dose (n=171,161, 175,170)
    1.550
    (0.0370)
    1.438
    (0.0378)
    1.576
    (0.0366)
    1.571
    (0.0369)
    5. Secondary Outcome
    Title Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points
    Description Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. Data within 6 hr of rescue medication use is excluded from this analysis.
    Time Frame Days 1, 8, 15, 22, 28 and 29 at all time points

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
    Arm/Group Title Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone Furoate 800 ug Via the Twisthaler® Device
    Arm/Group Description Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
    Measure Participants 178 172 179 175
    Day 1/30 min post-dose (n=172,172,175,173)
    65.043
    (0.2548)
    64.898
    (0.2556)
    65.184
    (0.2559)
    64.898
    (0.2554)
    Day 1/1 hr post-dose (n=178,169,174,175)
    65.177
    (0.2833)
    64.833
    (0.2890)
    65.005
    (0.2885)
    65.072
    (0.2845)
    Day 8/50 min pre-dose (n=174,171,179,175)
    66.566
    (0.4281)
    66.301
    (0.4286)
    67.344
    (0.4222)
    66.568
    (0.4264)
    Day 8/15 min pre-dose (n=176,172,179,174)
    66.595
    (0.4259)
    66.790
    (0.4262)
    67.778
    (0.4224)
    67.156
    (0.4252)
    Day 15 /50 min pre-dose (n=176,169,170,169)
    67.007
    (0.4329)
    66.122
    (0.4398)
    67.487
    (0.4395)
    67.139
    (0.4407)
    Day 15/15 min pre-dose (n=176,168,176,167)
    66.878
    (0.4370)
    66.006
    (0.4443)
    67.607
    (0.4384)
    67.514
    (0.4456)
    Day 22/50 min pre-dose (n=172,167,174,169)
    67.081
    (0.4594)
    66.567
    (0.4643)
    67.831
    (0.4584)
    67.742
    (0.4615)
    Day 22/15 min pre-dose (n=169,170,174,172)
    67.403
    (0.4657)
    66.885
    (0.4629)
    68.143
    (0.4622)
    67.895
    (0.4612)
    Day 28/50 min pre-dose (n=172,168,176,172)
    67.128
    (0.4584)
    66.835
    (0.4615)
    68.124
    (0.4567)
    67.810
    (0.4578)
    Day 28/15 min pre-dose (n=170,165,174, 170)
    67.503
    (0.4813)
    67.296
    (0.4854)
    68.255
    (0.4796)
    67.878
    (0.4804)
    Day 28/30 min post-dose (n=175,166,174,170)
    67.700
    (0.4723)
    67.013
    (0.4796)
    68.031
    (0.4755)
    68.126
    (0.4755)
    Day 28/30 min post-dose (n=173,167,172,172)
    67.945
    (0.4703)
    66.832
    (0.4741)
    68.243
    (0.4736)
    68.057
    (0.4698)
    Day 29/23hr 10 min post-dose (n=173,162,172,168)
    67.427
    (0.4639)
    66.711
    (0.4736)
    68.265
    (0.4654)
    67.592
    (0.4676)
    Day 29/23hr 45 min post-dose (n=172,161, 175,170)
    67.630
    (0.4694)
    66.541
    (0.4806)
    67.961
    (0.4667)
    67.831
    (0.4692)
    6. Secondary Outcome
    Title Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment
    Description Peak expiratory flow rate (PEFR) was measured via electronice Peak flow meter by patient at home. Mixed model used: change from baseline in the mean evening PEFR = treatment + age + gender + baseline evening PEFR + level of asthma control + region + center (region)+ error. Center is included as a random effect nested within region.
    Time Frame Baseline and week 4

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
    Arm/Group Title Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone Furoate 800 ug Via the Twisthaler® Device
    Arm/Group Description Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
    Measure Participants 177 172 175 182
    Morning 4 wks-baseline (n=177,171, 175, 182)
    -4.952
    (4.1929)
    3.955
    (4.2616)
    2.785
    (4.2349)
    1.606
    (4.1464)
    Evening 4 wks-baseline (n=176, 172, 174, 179)
    1.354
    (3.9003)
    0.293
    (3.9477)
    -0.644
    (3.9427)
    6.287
    (3.8826)
    7. Secondary Outcome
    Title Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit
    Description Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ-5 has five questions of the asthma symptoms to be answered by the patient. The overall score is the average of the 5 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. - Baseline ACQ-5 is defined as the questionnaire completed on Day 1 (randomization).
    Time Frame Baseline, days 8,15,22 and 29

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
    Arm/Group Title Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone Furoate 800 ug Via the Twisthaler® Device
    Arm/Group Description Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
    Measure Participants 180 176 182 182
    Day 8-baseline (n=179,176,182,182)
    -0.662
    (0.0543)
    -0.730
    (0.0546)
    -0.908
    (0.0540)
    -0.890
    (0.0538)
    Day 15-baseline(n=180,174,179,178)
    -0.899
    (0.0590)
    -0.908
    (0.0599)
    -1.117
    (0.0595)
    -0.973
    (0.0593)
    Day 22-baseline (n=178,173,178,177)
    -0.994
    (0.0620)
    -0.982
    (0.0628)
    -1.262
    (0.0622)
    -1.097
    (0.0622)
    Day 29-baseline (n=179,176,181,182)
    -1.079
    (0.0630)
    -1.109
    (0.602)
    -1.329
    (0.0632)
    -1.162
    (0.0625)
    8. Secondary Outcome
    Title Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment
    Description Rescue medication data recorded during the 14 day run-in period is used to calculate the baseline. - Total number of puffs of rescue medication per day over the full 4 weeks is calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the subject. - MIXED model: Change = treatment + gender + baseline mean daily number of puffs + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.
    Time Frame Baseline and 4 weeks

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
    Arm/Group Title Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone Furoate 800 ug Via the Twisthaler® Device
    Arm/Group Description Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
    Measure Participants 177 172 175 181
    Least Squares Mean (Standard Error) [number of puffs]
    -0.456
    (0.0972)
    -0.391
    (0.0985)
    -0.600
    (0.0981)
    -0.677
    (0.0963)
    9. Secondary Outcome
    Title Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment
    Description Mixed model used: percentage of days with no rescue medication use = treatment + age + gender + baseline percentage of days with no rescue use + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. A day with no rescue use is defined from diary data as any day where the subject does not use any puffs of rescue medication. The total number of days with no rescue use over the 4 week treatment period is divided by the total number of evaluable days in order to derive the percentage of days with no rescue use.
    Time Frame 4 weeks

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
    Arm/Group Title Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone Furoate 800 ug Via the Twisthaler® Device
    Arm/Group Description Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
    Measure Participants 124 116 117 113
    Least Squares Mean (Standard Error) [percentage days]
    74.148
    (2.2576)
    75.236
    (2.3291)
    75.157
    (2.3044)
    80.578
    (2.3476)
    10. Secondary Outcome
    Title Fractional Exhaled Nitric Oxide (FeNO)
    Description FeNO is widely accepted as a non-invasive marker for airway inflammation such as asthma and conducted according to published guideline. FeNO was measured on days 15 and 29 after treatment.
    Time Frame Days 15 and 29

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
    Arm/Group Title Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone Furoate 800 ug Via the Twisthaler® Device
    Arm/Group Description Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
    Measure Participants 142 143 145 150
    Day 15 (n= 142, 139, 139, 149)
    25.286
    (1.2983)
    26.762
    (1.3201)
    19.098
    (1.3246)
    21.017
    (1.2911)
    Day 29 (n=141, 143, 145, 150)
    23.777
    (1.3078)
    27.055
    (1.3035)
    18.468
    (1.2952)
    19.981
    (1.2803)
    11. Secondary Outcome
    Title Plasma Cortisol Concentrations
    Description Blood samples were taken from each subject participating in the study post dose at day 1 and week 4. Cortisol concentrations were evaluated. Results are presented as nmol/L
    Time Frame Baseline, days 1 and 28

    Outcome Measure Data

    Analysis Population Description
    The safety set includes all subjects who received at least one dose of study drug.
    Arm/Group Title Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone Furoate 800 ug Via the Twisthaler® Device
    Arm/Group Description Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
    Measure Participants 183 178 179 181
    Baseline (n= 183, 178, 179, 181)
    150.040
    (80.3928)
    143.132
    (88.4206)
    143.791
    (85.8696)
    150.108
    (88.6815)
    Day 1/1 Hr (n=179, 177,174, 176)
    118.130
    (92.7539)
    106.965
    (81.5160)
    107.526
    (74.3770)
    115.489
    (79.3869)
    Day 28/-25 Mins (n= 172, 169, 174, 172)
    140.760
    (73.3567)
    140.604
    (72.8885)
    143.555
    (82.4961)
    145.484
    (92.2940)
    Day 28/1 Hr (n= 172, 168, 174, 170)
    105.399
    (68.9416)
    107.931
    (70.7374)
    105.468
    (57.9029)
    110.477
    (77.2220)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone Furoate 800 ug Via the Twisthaler® Device Total
    Arm/Group Description Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening Total
    All Cause Mortality
    Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone Furoate 800 ug Via the Twisthaler® Device Total
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone Furoate 800 ug Via the Twisthaler® Device Total
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/186 (0%) 0/180 (0%) 1/183 (0.5%) 0/186 (0%) 1/735 (0.1%)
    Infections and infestations
    Pneumonia 0/186 (0%) 0/180 (0%) 1/183 (0.5%) 0/186 (0%) 1/735 (0.1%)
    Respiratory, thoracic and mediastinal disorders
    Asthma 0/186 (0%) 0/180 (0%) 1/183 (0.5%) 0/186 (0%) 1/735 (0.1%)
    Other (Not Including Serious) Adverse Events
    Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone Furoate 800 ug Via the Twisthaler® Device Total
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 13/186 (7%) 17/180 (9.4%) 15/183 (8.2%) 8/186 (4.3%) 53/735 (7.2%)
    Infections and infestations
    Nasopharyngitis 3/186 (1.6%) 7/180 (3.9%) 6/183 (3.3%) 2/186 (1.1%) 18/735 (2.4%)
    Investigations
    Blood cortisol decreased 4/186 (2.2%) 3/180 (1.7%) 5/183 (2.7%) 6/186 (3.2%) 18/735 (2.4%)
    Nervous system disorders
    Headache 6/186 (3.2%) 5/180 (2.8%) 5/183 (2.7%) 0/186 (0%) 16/735 (2.2%)
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain 0/186 (0%) 4/180 (2.2%) 1/183 (0.5%) 0/186 (0%) 5/735 (0.7%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

    Results Point of Contact

    Name/Title Clinical Disclosure Office
    Organization Novartis Pharmaceuticals
    Phone +1(862)778-8300
    Email
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01555151
    Other Study ID Numbers:
    • CQMF149E2201
    • 2011-005100-14
    First Posted:
    Mar 15, 2012
    Last Update Posted:
    May 1, 2015
    Last Verified:
    Apr 1, 2015