Assess Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma.

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: QVM149 150/50/80 μg o.d.; Drug: QVM149 150/50/160 μg o.d.; Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d.

• Registration Number: NCT03063086
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The purpose of this study is to assess peak FEV1 of two doses of QVM149 compared to a fixed-dose combination of salmeterol/fluticasone (50/500μg b.i.d.) and to characterize the respective 24 hour bronchodilator effect profiles in patients with asthma. Data from this study will complement lung function data obtained in the pivotal QVM149 phase 3 program by assessing the bronchodilatory effect of QVM149 at multiple time-points over an entire dosing interval of 24 hours.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-21
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-24
• Primary Completion: 2018-08-02
• Study Completion: 2018-08-02
• Results First Submitted: 2019-07-31
• Results First Submitted QC: 2019-11-25
• Results First Posted: 2019-12-13
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	salmeterol/fluticasone FDC 50/500 μg b.i.d.	A-B-C
Sequence 2	salmeterol/fluticasone FDC 50/500 μg b.i.d.	A-C-B
Sequence 6	salmeterol/fluticasone FDC 50/500 μg b.i.d.	C-B-A
Sequence 4	QVM149 150/50/160 μg o.d.	B-A-C
Sequence 5	QVM149 150/50/160 μg o.d.	C-A-B
Sequence 5	salmeterol/fluticasone FDC 50/500 μg b.i.d.	C-A-B
Sequence 6	QVM149 150/50/80 μg o.d.	C-B-A
Sequence 3	QVM149 150/50/160 μg o.d.	B-C-A
Sequence 1	QVM149 150/50/80 μg o.d.	A-B-C
Sequence 2	QVM149 150/50/160 μg o.d.	A-C-B
Sequence 2	QVM149 150/50/80 μg o.d.	A-C-B
Sequence 4	QVM149 150/50/80 μg o.d.	B-A-C
Sequence 4	salmeterol/fluticasone FDC 50/500 μg b.i.d.	B-A-C
Sequence 6	QVM149 150/50/160 μg o.d.	C-B-A
Sequence 1	QVM149 150/50/160 μg o.d.	A-B-C
Sequence 3	QVM149 150/50/80 μg o.d.	B-C-A
Sequence 3	salmeterol/fluticasone FDC 50/500 μg b.i.d.	B-C-A
Sequence 5	QVM149 150/50/80 μg o.d.	C-A-B

Primary Outcome Measures

Name	Time	Method
Peak FEV1 (L) Defined as the Highest Bronchodilatory Effect on FEV1 During a Period of 5 Min to 4 h After the Last Evening Dose of Each Treatment Period	3 weeks	The highest bronchodilator effect on FEV1 during a period of 5 min to 4 h after the last evening dose of each treatment period . To demonstrate superiority in peak bronchodilator effect of QVM149 at a dose of 150/50/160 μg o.d. and 150/50/80 μg o.d. compared to a FDC of salmeterol/fluticasone at a dose of 50/500 μg b.i.d. after 3 weeks of treatment in patients with asthma

Secondary Outcome Measures

Name	Time	Method
FEV1 AUC 5 Min - 1 h (Day 21) FEV1 AUC 5 Min - 4 h (Day 21) and FEV1 AUC 5 Min - 23 h 45 Min (Day 21)	3 weeks	To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/ fluticasone FDC by measuring standardized FEV1 AUCs after 3 weeks of treatment respective period.
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose	-45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeks	To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment at -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min.
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose	-45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeks	To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment at -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min.
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose	-45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeks	To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment at -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min.
Trough FEV1 After 21 Days of Treatment	3 weeks	To evaluate post-dose trough bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment in the respective treatment period. The trough FEV1 is the mean value of FEV1 at 23 h 15 min and 23 h 45 min post-dose

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Manchester, United Kingdom