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A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS)

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05202262
Collaborator
(none)
630
Enrollment
122
Locations
4
Arms
20.6
Anticipated Duration (Months)
5.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a 24 week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler in adults and adolescents with inadequately controlled asthma.

Condition or Disease Intervention/Treatment Phase
  • Drug: BFF MDI 320/9.6 μg
  • Drug: BFF MDI 160/9.6 μg
  • Drug: BD MDI 320 μg
  • Drug: Open-label Symbicort TBH 320/9 μg
 Phase 3

Detailed Description

This is a Phase III randomized, double-blind, active comparison, parallel group, multicenter study comparing BFF MDI 320/9.6 μg to BD MDI 320 µg and open-label Symbicort TBH 320/9 μg in adult and adolescent participants who have asthma which remains inadequately controlled (ACQ-7 total score ≥ 1.5) despite treatment with medium dose ICS or ICS/LABA. Budesonide and Formoterol Fumarate MDI 160/9.6 μg is included in this study to evaluate dose response by comparing to BFF MDI 320/9.6 μg. All doses represent the sum of 2 actuations. All study interventions will be administered BID for 24 weeks.

This study will be conducted at approximately 125 sites worldwide and will randomize approximately 630 adult and adolescent participants.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
630 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Open Label for Symbicort TBH
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Parallel Group, Multicenter 24 Week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler and Open-Label Symbicort® Turbuhaler® in Participants With Inadequately Controlled Asthma (VATHOS).
Actual Study Start Date :
Jan 12, 2022
Anticipated Primary Completion Date :
Oct 2, 2023
Anticipated Study Completion Date :
Oct 2, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: BFF MDI 320/9.6 μg

Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg

Drug: BFF MDI 320/9.6 μg
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
Other Names:
  • BFF

    		•
    Experimental: BFF MDI 160/9.6 μg

    Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg

    Drug: BFF MDI 160/9.6 μg
    Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
    Other Names:
  • BFF

    		•
    Experimental: BD MDI 320 μg

    Budesonide MDI (BD MDI), 320 μg

    Drug: BD MDI 320 μg
    Budesonide MDI (BD MDI), 320 μg
    Other Names:
  • BD

    		•
    Active Comparator: Open-label Symbicort TBH 320/9 μg

    Open-Label Comparator Symbicort Turbuhaler 320/9 μg

    Drug: Open-label Symbicort TBH 320/9 μg
    Open-label Symbicort Turbuhaler 320/9 μg
    Other Names:
  • Symbicort TBH

    		•

    Outcome Measures

    Primary Outcome Measures

    1. United States (US): Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24 [at week 24]

      United States (US): Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24

    Secondary Outcome Measures

    1. US (Key secondary): Change from baseline in morning pre-dose trough FEV1 at Week 24 [at week 24]

      US (Key secondary): Change from baseline in morning pre-dose trough FEV1 at Week 24

    2. Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 24 Weeks [over 24 weeks]

      Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 24 Weeks

    3. Percentage of responders in ACQ-7 (≥ 0.5 decrease equals response) at Week 24 [at week 24]

      Percentage of responders in ACQ-7 (≥ 0.5 decrease equals response) at Week 24

    4. Percentage of responders in ACQ-5 (≥ 0.5 decrease equals response) at Week 24 [at Week 24]

      Percentage of responders in ACQ-5 (≥ 0.5 decrease equals response) at Week 24

    5. Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s)+12) (≥ 0.5 increase equals response) at Week 24 [at Week 24]

      Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s)+12) (≥ 0.5 increase equals response) at Week 24

    6. Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1 [Day 1]

      Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. 12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.

    2. Participants who have a documented history of physician-diagnosed asthma ≥ 6 months prior to Visit 1, according to GINA guidelines [GINA 2020]. Healthcare records for 1 year prior to Visit 1 must be provided for adolescent participants (12 to < 18 years of age) to ensure consistent evaluation and follow-up of treatment in those participants.

    3. Participants who have been regularly using a stable daily ICS or an ICS/LABA regimen (including a stable ICS dose), with the ICS doses, for at least 8 weeks prior to Visit

    5. ACQ-7 total score ≥ 1.5 at Visits 1 and 4.

    6. Pre-bronchodilator/pre-dose FEV1 <90% predicted normal value at Visits 1, 2 and 3, and a pre-dose FEV1 of 50% to 90% at Visit 4 (pre-randomization).

    7. Reversibility to albuterol, defined as a post-albuterol increase in FEV1 of ≥ 12% and ≥ 200 mL for participants ≥ 18 years of age OR a post-albuterol increase of FEV1 of ≥ 12% for participants 12 to < 18 years of age, either in the 12 months prior to Visit 1 or at Visit 2 or Visit 3.

    8. A pre-bronchodilator/pre-dose FEV1 at Visits 2, 3, and 4 that have not changed 20% or more (increase or decrease) from the pre-bronchodilator/pre-dose FEV1 recorded at the previous visit.

    9. Demonstrate acceptable MDI administration technique.

    10. eDiary compliance ≥ 70% during screening, defined as completing the daily eDiary and answering "Yes" to taking 2 puffs of run-in BD MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization.

    Exclusion Criteria:

    1. Life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s).

    2. Any respiratory infection or asthma exacerbation treated with systemic corticosteroids and/or additional ICS treatment in the 8 weeks prior to Visit 1 and throughout the Screening Period.

    3. Hospitalization for asthma within 8 weeks of Visit 1.

    4. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary (eg, active tuberculosis, bronchiectasis, pulmonary eosinophilic syndromes, and COPD). Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analysis.

    5. Known history of drug or alcohol abuse within 12 months of Visit 1.

    6. Use of a nebulizer or a home nebulizer for receiving asthma medications.

    7. Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months prior to Visit 1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).

    8. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.

    9. For women only - currently pregnant (confirmed with positive highly sensitive urine pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Saraland Alabama United States 36571
    2 Research Site Bakersfield California United States 93301
    3 Research Site Bakersfield California United States 93309
    4 Research Site Huntington Beach California United States 92647
    5 Research Site Lincoln California United States 95648
    6 Research Site Los Angeles California United States 90017
    7 Research Site Los Angeles California United States 90025
    8 Research Site Los Angeles California United States 90048
    9 Research Site Newport Beach California United States 92663
    10 Research Site Palm Springs California United States 92262
    11 Research Site San Diego California United States 92120
    12 Research Site San Diego California United States 92123
    13 Research Site San Jose California United States 95117
    14 Research Site Denver Colorado United States 80230
    15 Research Site Lexington Kentucky United States 40509
    16 Research Site White Marsh Maryland United States 21162
    17 Research Site North Dartmouth Massachusetts United States 02747
    18 Research Site Ann Arbor Michigan United States 48109
    19 Research Site Farmington Hills Michigan United States 48336
    20 Research Site Columbia Missouri United States 65203
    21 Research Site Saint Charles Missouri United States 63301
    22 Research Site Saint Louis Missouri United States 63141
    23 Research Site Missoula Montana United States 59808
    24 Research Site Bellevue Nebraska United States 68123
    25 Research Site Omaha Nebraska United States 68114
    26 Research Site Skillman New Jersey United States 08558
    27 Research Site Charlotte North Carolina United States 28277
    28 Research Site Gastonia North Carolina United States 28054
    29 Research Site Greensboro North Carolina United States 27410
    30 Research Site Monroe North Carolina United States 28112
    31 Research Site Raleigh North Carolina United States 27607
    32 Research Site Cincinnati Ohio United States 45236
    33 Research Site Edmond Oklahoma United States 73034
    34 Research Site Oklahoma City Oklahoma United States 73120
    35 Research Site Portland Oregon United States 97202
    36 Research Site Austin Texas United States 78759
    37 Research Site Boerne Texas United States 78006
    38 Research Site El Paso Texas United States 79903
    39 Research Site Houston Texas United States 77093
    40 Research Site Red Oak Texas United States 75154
    41 Research Site San Antonio Texas United States 78229
    42 Research Site Waco Texas United States 76712
    43 Research Site Williamsburg Virginia United States 23188
    44 Research Site Milwaukee Wisconsin United States 53228
    45 Research Site Calgary Alberta Canada T3B 0M3
    46 Research Site Calgary Alberta Canada T3E 7M8
    47 Research Site Edmonton Alberta Canada T5A 4L8
    48 Research Site Winnipeg Manitoba Canada R3L 1Z5
    49 Research Site Moncton New Brunswick Canada E1G 1A7
    50 Research Site Ajax Ontario Canada L1S 2J5
    51 Research Site Barrie Ontario Canada L4N 1B3
    52 Research Site Burlington Ontario Canada L7N 3V2
    53 Research Site Stouffville Ontario Canada L4A 1H2
    54 Research Site Toronto Ontario Canada M9V 4B4
    55 Research Site Windsor Ontario Canada N8X 2G1
    56 Research Site Montreal Quebec Canada H3G 1L5
    57 Research Site Trois-Rivières Quebec Canada G8T 7A1
    58 Research Site Quebec Canada G1G 3Y8
    59 Research Site Quebec Canada G1V 4W2
    60 Research Site Quebec Canada G2J 0C4
    61 Research Site Berlin Germany 10119
    62 Research Site Berlin Germany 10787
    63 Research Site Berlin Germany 10969
    64 Research Site Berlin Germany 12157
    65 Research Site Berlin Germany 13156
    66 Research Site Landsberg Germany 86899
    67 Research Site Leipzig Germany 04157
    68 Research Site Leipzig Germany 04207
    69 Research Site Leipzig Germany 04275
    70 Research Site Magdeburg Germany 39120
    71 Research Site München-Pasing Germany 81241
    72 Research Site Rüdersdorf Germany 15562
    73 Research Site Schleswig Germany 24837
    74 Research Site Wiesbaden Germany 65189
    75 Research Site Witten Germany 58452
    76 Research Site Brescia Italy 25123
    77 Research Site Milano Italy 20154
    78 Research Site Napoli Italy 80131
    79 Research Site Roma Italy 00133
    80 Research Site Roma Italy 00168
    81 Research Site Rome Italy 00165
    82 Research Site Tradate Italy 21049
    83 Research Site Chuo-ku Japan 103-0022
    84 Research Site Chuo-ku Japan 103-0027
    85 Research Site Chuo-ku Japan 103-0028
    86 Research Site Chuo-ku Japan 104-0031
    87 Research Site Fuchu-shi Japan 183-8561
    88 Research Site Fukui-shi Japan 910-8526
    89 Research Site Fukuoka-shi Japan 819-8555
    90 Research Site Habikino-shi Japan 583-8588
    91 Research Site Himeji-shi Japan 672-8064
    92 Research Site Ikoma-shi Japan 630-0293
    93 Research Site Kagoshima City Japan 890-0053
    94 Research Site Kodaira-shi Japan 187-0024
    95 Research Site Kokubunji-shi Japan 185-0014
    96 Research Site Kusatsu-shi Japan 525-8585
    97 Research Site Kyoto-shi Japan 601-8213
    98 Research Site Maebashi-shi Japan 371-0811
    99 Research Site Mizunami-shi Japan 509-6134
    100 Research Site Obihiro-shi Japan 080-0013
    101 Research Site Osaka-shi Japan 531-0073
    102 Research Site Sapporo-shi Japan 062-0931
    103 Research Site Setagaya-ku Japan 158-0097
    104 Research Site Shibuya-ku Japan 150-0013
    105 Research Site Tanabe-shi Japan 646-8558
    106 Research Site Toon-shi Japan 791-0281
    107 Research Site Toshima-ku Japan 170-0002
    108 Research Site Toshima-ku Japan 170-0003
    109 Research Site Toshima-ku Japan 171-0014
    110 Research Site Utsunomiya-shi Japan 329-1193
    111 Research Site Yokohama-shi Japan 223-0059
    112 Research Site Yokohama-shi Japan 231-8682
    113 Research Site Yokohama-shi Japan 232-0024
    114 Research Site Yokohama Japan 232-0064
    115 Research Site A Coruña Spain 15006
    116 Research Site Alcorcón Spain 28922
    117 Research Site Alzira Spain 46410
    118 Research Site Badalona Spain 08916
    119 Research Site Burgos Spain 09006
    120 Research Site Granada Spain 18014
    121 Research Site Madrid Spain 28007
    122 Research Site Oviedo Spain 33006

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT05202262
    Other Study ID Numbers:
    • D5982C00006
    • 2021-002026-24
    First Posted:
    Jan 21, 2022
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Asthma
    Budesonide, Formoterol Fumarate Drug Combination

    Study Results

    No Results Posted as of Aug 23, 2022