Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma
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| ClinicalTrials.gov Identifier: NCT02571777 |
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Recruitment Status :
Completed
First Posted : October 8, 2015
Results First Posted : July 22, 2020
Last Update Posted : July 22, 2020
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Asthma |
| Interventions |
Drug: QVM149 150/50/160 Drug: QVM149 150/50/80 Drug: QMF149 150/320 Drug: QMF149 150/160 Drug: salmeterol/fluticasone |
| Enrollment | 3092 |
Participant Flow
| Recruitment Details | Participants took part in 415 investigative sites in 41 countries |
| Pre-assignment Details | 4851 participants were screened of which 3092 participants were randomized to 1 of the 5 treatment groups with a randomization ratio of 1:1:1:1:1. |
| Arm/Group Title | QVM149 150/50/160 µg o.d. | QVM149 150/50/80 µg o.d. | QMF149 150/320 µg o.d. | QMF149 150/160 µg o.d. | Salmeterol/Fluticasone 50/500 μg b.i.d. |
|---|---|---|---|---|---|
 Arm/Group Description |
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device | QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device | QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device | QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device | Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler® |
| Period Title: Overall Study | |||||
| Started [1] | 619 | 620 | 618 | 617 | 618 |
| Full Analysis Set (FAS) [2] | 615 | 616 | 611 | 607 | 612 |
| Safety Set (SAF) [3] | 616 | 617 | 613 | 608 | 618 |
| Completed | 580 | 582 | 577 | 580 | 582 |
| Not Completed | 39 | 38 | 41 | 37 | 36 |
| Reason Not Completed | |||||
| Subject/guardian decision | 34 | 26 | 26 | 25 | 27 |
| Protocol Deviation | 2 | 3 | 4 | 8 | 4 |
| Death | 1 | 1 | 4 | 0 | 0 |
| Lost to Follow-up | 1 | 1 | 2 | 0 | 1 |
| Physician Decision | 1 | 7 | 5 | 2 | 4 |
| Pregnancy | 0 | 0 | 0 | 2 | 0 |
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[1]
All patients who were assigned a randomization number
[2]
All patients in the randomization set who received at least one dose of study medication
[3]
All patients who received at least one dose of study medication whether or not being randomized
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Baseline Characteristics
| Arm/Group Title | QVM149 150/50/160 µg o.d. | QVM149 150/50/80 µg o.d. | QMF149 150/320 µg o.d. | QMF149 150/160 µg o.d. | Salmeterol/Fluticasone 50/500 μg b.i.d. | Total | |
|---|---|---|---|---|---|---|---|
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Arm/Group Description |
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device | QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device | QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device | QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device | Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler® | Total of all reporting groups | |
| Overall Number of Baseline Participants | 619 | 620 | 618 | 617 | 618 | 3092 | |
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Baseline Analysis Population Description |
Randomized Set (RAN) consisted of all participants who were assigned a randomization number, regardless of whether or not they actually received study medication.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 619 participants | 620 participants | 618 participants | 617 participants | 618 participants | 3092 participants | |
| 52.1 (12.91) | 52.4 (12.71) | 52.0 (12.81) | 51.8 (12.86) | 52.9 (12.23) | 52.2 (12.70) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 619 participants | 620 participants | 618 participants | 617 participants | 618 participants | 3092 participants | |
| Female |
381 61.6%
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362 58.4%
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380 61.5%
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378 61.3%
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417 67.5%
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1918 62.0%
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| Male |
238 38.4%
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258 41.6%
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238 38.5%
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239 38.7%
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201 32.5%
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1174 38.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 619 participants | 620 participants | 618 participants | 617 participants | 618 participants | 3092 participants | |
| Caucasian |
456 73.7%
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458 73.9%
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453 73.3%
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452 73.3%
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468 75.7%
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2287 74.0%
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| Black |
4 0.6%
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5 0.8%
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3 0.5%
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4 0.6%
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1 0.2%
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17 0.5%
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| Asian |
139 22.5%
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133 21.5%
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133 21.5%
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135 21.9%
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131 21.2%
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671 21.7%
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| Native American |
7 1.1%
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8 1.3%
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8 1.3%
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4 0.6%
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5 0.8%
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32 1.0%
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| Unknown |
0 0.0%
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0 0.0%
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0 0.0%
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1 0.2%
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0 0.0%
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1 0.0%
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| Other |
13 2.1%
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16 2.6%
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21 3.4%
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21 3.4%
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13 2.1%
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84 2.7%
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