Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT03108027

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

5.4

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This was a randomized, placebo-controlled, double-blind, six-sequence, three-period cross-over study in asthma patients. The study consisted of a 14-day screening period, followed by a 14-day run-in period, and a treatment epoch which consists of three treatment periods, with a minimum duration of 14 days each followed (for the 2 first treatment periods) by a wash-out period. The duration of each treatment period may be extended up to a duration of 18 days if needed for operational reasons. The third treatment period was followed by a Study Completion evaluation at 1-7 days following the last dose. The treatment periods were separated by wash-out periods of 14 to 21 days duration.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose) Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose) Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

This study is to assess the bronchodilator effects of QVM149 dosed once daily either in the morning or in the evening for 2 weeks compared to placebo. It will provide evidence of the comparability of lung function effects of QVM149 irrespective of the administration scheduleThis study is to assess the bronchodilator effects of QVM149 dosed once daily either in the morning or in the evening for 2 weeks compared to placebo. It will provide evidence of the comparability of lung function effects of QVM149 irrespective of the administration schedule

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

This is a double-blind masking.

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Repeat Dose Cross-over Study to Assess the Bronchodilator Effects of Once Daily QVM149 Following Morning or Evening Dosing for 14 Days Compared to Placebo in Patients With Asthma

Actual Study Start Date :

Jun 26, 2017

Actual Primary Completion Date :

Feb 24, 2018

Actual Study Completion Date :

Feb 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 Patients will receive in a sequential order the following interventional treatments: A,B and C.	Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose) Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose) Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose) QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose) Drug: Treatment C: Placebo (morning dose) and placebo (evening dose) Placebo (morning dose) and placebo (evening dose)
Experimental: Sequence 2 Patients will receive in a sequential order the following interventional treatments: B, A and C.	Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose) Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose) Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose) QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose) Drug: Treatment C: Placebo (morning dose) and placebo (evening dose) Placebo (morning dose) and placebo (evening dose)
Experimental: Sequence 3 Patients will receive in a sequential order the following interventional treatments: C, B and A.	Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose) Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose) Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose) QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose) Drug: Treatment C: Placebo (morning dose) and placebo (evening dose) Placebo (morning dose) and placebo (evening dose)
Experimental: Sequence 4 Patients will receive in a sequential order the following interventional treatments : C, A and B.	Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose) Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose) Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose) QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose) Drug: Treatment C: Placebo (morning dose) and placebo (evening dose) Placebo (morning dose) and placebo (evening dose)
Experimental: Sequence 5 Patients will receive in a sequential order the following interventional treatments: A, C and B.	Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose) Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose) Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose) QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose) Drug: Treatment C: Placebo (morning dose) and placebo (evening dose) Placebo (morning dose) and placebo (evening dose)
Experimental: Sequence 6 Patients will receive in a sequential order the following interventional treatments: B, C and A.	Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose) Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose) Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose) QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose) Drug: Treatment C: Placebo (morning dose) and placebo (evening dose) Placebo (morning dose) and placebo (evening dose)

Outcome Measures

Primary Outcome Measures

FEV1 Standardized Area Under the Curve (AUC 0-24h) After Last Evening Dose of 14-day Treatment Period [At the end of each treatment period day 14 pre-dose to 24 hours post-dose.]
Weighted mean forced expiratory volume in 1 second (FEV1) over 24 h (AUC0-24h) following 14 days of treatment with QVM149 dosed in the morning, QVM149 dosed in the evening and placebo.

Secondary Outcome Measures

Trough FEV1 After 24h [At the end of each treatment period day 14 pre-dose to 24 hours post-dose.]
FEV1 at approximately 24 h after the last p.m. or penultimate a.m. dose. Morning and evening trough FEV1 (L) were analyzed by time of day. For morning trough FEV1 (L) assessments this meant that the spirometric assessment was done approximately 24 h after last morning dose and approximately 12 h after last evening dose.
Peak Expiratory Flow (PEF) [From treatment period start through study completion (up to 19 weeks).]
Peak expiratory flow (PEF) is the maximum flow generated during a forceful exhalation, starting from full lung inflationDaily morning and evening peak expiratory flow rate from Day 2 to Day14 during the three treatment periods.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with a documented physician diagnosis of asthma and who additionally meet the following criteria:

Patients receiving daily treatment with an inhaled corticosteroid at a low or medium daily dose
On a stable regimen for at least 4 weeks prior to screening.
Pre-bronchodilator FEV1 ≥ 60 % and < 100% of the predicted normal value for the patient during screening.
Patients who demonstrate an increase in FEV1 of ≥ 12 % and ≥ 200 mL after administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at Screening. All patients must perform a reversibility test at Screening.
At screening, and baseline (day 1 pre-dose time) of the first treatment period, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position and again in the standing position as outlined in the SOM. Sitting and standing vital signs should be within the following ranges:
oral body temperature between 35.0-37.5 °C
systolic blood pressure, 90-159 mmHg
diastolic blood pressure, 50-99 mmHg
pulse rate, 40-90 bpm
Hypertensive patients must have been on stable antihypertensive therapy for at least 4 weeks prior to screening to be included in the trial.
Patients must weigh at least 50 kg at screening to participate in the study, and must have a body mass index (BMI) within the range of 18 to 40 kg/m2.

Exclusion Criteria:

Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the drugs of a similar class
Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 1 year of Screening.
Patients who have had previous intubation for a severe asthma ttack/exacerbation.
Patients with a history of clinically relevant bronchoconstriction upon repeated forced expiratory maneuvers.
History of paradoxical bronchospasm in response to inhaled medicines.
Patients who during the run-in period prior to randomization require the use of ≥12 puffs / 24 hours of rescue medication for 48 hours (over two consecutive days) or who have a decline in PEF from the reference PEFof ≥ 30% for 6 consecutive scheduled PEF readings
Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Berlin		Germany	10117
2	Novartis Investigative Site	Frankfurt Am Main Hessen		Germany	60596
3	Novartis Investigative Site	Grosshansdorf		Germany	22947
4	Novartis Investigative Site	Hannover		Germany	30625
5	Novartis Investigative Site	Wiesbaden		Germany	65187
6	Novartis Investigative Site	Groningen	GZ	Netherlands	9713
7	Novartis Investigative Site	Machester		United Kingdom	M23 9QZ

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

More Information

Additional Information:

A Plain Language Trial Summary is available on novartisclinicatrials.com

Publications

None provided.

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT03108027

Other Study ID Numbers:

CQVM149B2209
2017-000644-17

First Posted:

Apr 11, 2017

Last Update Posted:

Jan 5, 2021

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Novartis Pharmaceuticals

QVM149,

asthma,

allergic asthma,

allergy triggered asthma,

reactive asthma,

asthma attack,

difficulty breathing

Additional relevant MeSH terms:

Asthma

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Sequence 5	Sequence 6
Arm/Group Description	Patients received in a sequential order the following interventional treatments: A,B and C.	Patients received in a sequential order the following interventional treatments: B, A and C.	Patients received in a sequential order the following interventional treatments: C, B and A.	Patients received in a sequential order the following interventional treatments : C, A and B.	Patients received in a sequential order the following interventional treatments: A, C and B.	Patients received in a sequential order the following interventional treatments: B, C and A.
Period Title: Period 1
STARTED	7	6	6	6	6	6
COMPLETED	7	6	6	4	6	6
NOT COMPLETED	0	0	0	2	0	0
Period Title: Period 1
STARTED	7	6	6	4	6	6
COMPLETED	7	6	6	4	6	6
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1
STARTED	7	6	6	4	6	6
COMPLETED	7	5	6	4	6	6
NOT COMPLETED	0	1	0	0	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	All participants randomized to one of six treatment sequences
Overall Participants	37
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	43.5 (14.04)
Sex: Female, Male (Count of Participants)
Female	16 43.2%
Male	21 56.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	35 94.6%
More than one race	0 0%
Unknown or Not Reported	2 5.4%

Outcome Measures

1. Primary Outcome

Title	FEV1 Standardized Area Under the Curve (AUC 0-24h) After Last Evening Dose of 14-day Treatment Period
Description	Weighted mean forced expiratory volume in 1 second (FEV1) over 24 h (AUC0-24h) following 14 days of treatment with QVM149 dosed in the morning, QVM149 dosed in the evening and placebo.
Time Frame	At the end of each treatment period day 14 pre-dose to 24 hours post-dose.

Outcome Measure Data

Analysis Population Description
The pharmacodynamic (PD) analysis set included all patients with any available PD data, who received any dose of study drug and experienced no protocol deviations with relevant impact on PD data.

Arm/Group Title	QVM149 am	QVM149 pm	Placebo
Arm/Group Description	QVM149 150/50/80 μg o.d. (indacaterol acetate 150 μg/ glycopyrronium bromide 50 μg/ MF 80 μg once daily) administered in the morning (plus matching placebo in the evening)	QVM149 150/50/80 μg o.d. (indacaterol acetate150 μg/ glycopyrronium bromide 50 μg/ MF 80 μg once daily) administered in the evening (plus matching placebo in the morning)	Placebo administered in the morning and in the evening.
Measure Participants	30	30	33
Least Squares Mean (Standard Error) [Liters]	3.4305 (0.15242)	3.4361 (0.15213)	2.8209 (0.15259)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	QVM149 am, Placebo
	Comments
	Type of Statistical Test	Other
	Comments	A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.6096
	Confidence Interval	(2-Sided) 90% 0.5380 to 0.6811
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	QVM149 pm, Placebo
	Comments
	Type of Statistical Test	Other
	Comments	A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.6152
	Confidence Interval	(2-Sided) 90% 0.5437 to 0.6868
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	QVM149 am, QVM149 pm
	Comments
	Type of Statistical Test	Other
	Comments	A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.0057
	Confidence Interval	(2-Sided) 90% -0.0760 to 0.0647
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Trough FEV1 After 24h
Description	FEV1 at approximately 24 h after the last p.m. or penultimate a.m. dose. Morning and evening trough FEV1 (L) were analyzed by time of day. For morning trough FEV1 (L) assessments this meant that the spirometric assessment was done approximately 24 h after last morning dose and approximately 12 h after last evening dose.
Time Frame	At the end of each treatment period day 14 pre-dose to 24 hours post-dose.

Outcome Measure Data

Analysis Population Description
The pharmacodynamic (PD) analysis set included all patients with any available PD data, who received any dose of study drug and experienced no protocol deviations with relevant impact on PD data

Arm/Group Title	QVM149 am	QVM149 pm	Placebo
Arm/Group Description	QVM149 150/50/80 μg o.d. (indacaterol acetate 150 μg/ glycopyrronium bromide 50 μg/ MF 80 μg once daily) administered in the morning (plus matching placebo in the evening)	QVM149 150/50/80 μg o.d. (indacaterol acetate150 μg/ glycopyrronium bromide 50 μg/ MF 80 μg once daily) administered in the evening (plus matching placebo in the morning)	Placebo administered in the morning and in the evening.
Measure Participants	35	35	36
Least Squares Mean (Standard Error) [Liters]	3.3731 (0.15037)	3.4871 (0.15041)	2.7524 (0.15120)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	QVM149 am, Placebo
	Comments
	Type of Statistical Test	Other
	Comments	A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.6206
	Confidence Interval	(2-Sided) 90% 0.5335 to 0.7077
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	QVM149 pm, Placebo
	Comments
	Type of Statistical Test	Other
	Comments	A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.7347
	Confidence Interval	(2-Sided) 90% 0.6469 to 0.8225
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	QVM149 am, QVM149 pm
	Comments
	Type of Statistical Test	Other
	Comments	A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.1141
	Confidence Interval	(2-Sided) 90% -0.1970 to -0.0311
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Peak Expiratory Flow (PEF)
Description	Peak expiratory flow (PEF) is the maximum flow generated during a forceful exhalation, starting from full lung inflationDaily morning and evening peak expiratory flow rate from Day 2 to Day14 during the three treatment periods.
Time Frame	From treatment period start through study completion (up to 19 weeks).

Outcome Measure Data

Analysis Population Description
The pharmacodynamic (PD) analysis set included all patients with any available PD data, who received any dose of study drug and experienced no protocol deviations with relevant impact on PD data

Arm/Group Title	QVM149 am	QVM149 pm	Placebo
Arm/Group Description	QVM149 150/50/80 μg o.d. (indacaterol acetate 150 μg/ glycopyrronium bromide 50 μg/ MF 80 μg once daily) administered in the morning (plus matching placebo in the evening)	QVM149 150/50/80 μg o.d. (indacaterol acetate150 μg/ glycopyrronium bromide 50 μg/ MF 80 μg once daily) administered in the evening (plus matching placebo in the morning)	Placebo administered in the morning and in the evening.
Measure Participants	35	35	36
Morning average PEF	489.6 (19.77)	504.4 (19.78)	417.5 (19.73)
Evening average PEF	522.0 (19.71)	507.7 (19.71)	449.0 (19.67)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	QVM149 am, Placebo
	Comments	Morning average PEF
	Type of Statistical Test	Other
	Comments	A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	72.1
	Confidence Interval	(2-Sided) 90% 61.3 to 82.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	QVM149 pm, Placebo
	Comments	Morning average PEF
	Type of Statistical Test	Other
	Comments	A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	86.9
	Confidence Interval	(2-Sided) 90% 76.1 to 97.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	QVM149 am, QVM149 pm
	Comments	Morning average PEF
	Type of Statistical Test	Other
	Comments	A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-14.8
	Confidence Interval	(2-Sided) 90% -25.6 to -4.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	QVM149 am, Placebo
	Comments	Evening average PEF
	Type of Statistical Test	Other
	Comments	A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	73.1
	Confidence Interval	(2-Sided) 90% 61.9 to 84.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	QVM149 pm, Placebo
	Comments	Evening average PEF
	Type of Statistical Test	Other
	Comments	A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	58.7
	Confidence Interval	() 90% 47.5 to 69.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	QVM149 am, QVM149 pm
	Comments	Evening average PEF
	Type of Statistical Test	Other
	Comments	A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	14.4
	Confidence Interval	(2-Sided) 90% 3.3 to 25.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

	QVM149 a.m.		QVM149 p.m.		Placebo
Time Frame	Up to 19 weeks
Adverse Event Reporting Description

Arm/Group Title	QVM149 a.m.		QVM149 p.m.		Placebo
Arm/Group Description	QVM149 150/50/80 μg o.d. (indacaterol acetate 150 μg/ glycopyrronium bromide 50 μg/ MF 80 μg once daily) administered in the morning (plus matching placebo in the evening)		QVM149 150/50/80 μg o.d. (indacaterol acetate150 μg/ glycopyrronium bromide 50 μg/ MF 80 μg once daily) administered in the evening (plus matching placebo in the morning)		Placebo administered in the morning and in the evening
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/35 (0%)		0/36 (0%)
Serious Adverse Events
	QVM149 a.m.		QVM149 p.m.		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/35 (0%)		0/36 (0%)
Other (Not Including Serious) Adverse Events
	QVM149 a.m.		QVM149 p.m.		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/35 (31.4%)		13/35 (37.1%)		16/36 (44.4%)
Infections and infestations
Nasopharyngitis	2/35 (5.7%)		2/35 (5.7%)		5/36 (13.9%)
Nervous system disorders
Headache	5/35 (14.3%)		3/35 (8.6%)		7/36 (19.4%)
Respiratory, thoracic and mediastinal disorders
Cough	1/35 (2.9%)		2/35 (5.7%)		1/36 (2.8%)
Dysphonia	2/35 (5.7%)		3/35 (8.6%)		1/36 (2.8%)
Oropharyngeal pain	3/35 (8.6%)		4/35 (11.4%)		2/36 (5.6%)

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 or disclosure of trial results in their entirety

Results Point of Contact

Name/Title	Study Director
Organization	Novartis Pharmaceutical
Phone	862-778-8300
Email	novartis.email@novartis.com

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT03108027

Other Study ID Numbers:

CQVM149B2209
2017-000644-17

First Posted:

Apr 11, 2017

Last Update Posted:

Jan 5, 2021

Last Verified:

May 1, 2019

Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Statistical Analysis 4

Statistical Analysis 5

Statistical Analysis 6

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact