← Back to Search

Bronchodilator

QVA149 for Chronic Obstructive Pulmonary Disease

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up bl, day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; day 2: 23h15min, 23h45min; day 15: -45min, -15min, 1h; day 29: -45 min, -15min, 1h; day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial

Summary

This study will assess the efficacy, safety and tolerability of indacaterol maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~bl, day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; day 2: 23h15min, 23h45min; day 15: -45min, -15min, 1h; day 29: -45 min, -15min, 1h; day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min
This trial's timeline: 3 weeks for screening, Varies for treatment, and bl, day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; day 2: 23h15min, 23h45min; day 15: -45min, -15min, 1h; day 29: -45 min, -15min, 1h; day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))
Secondary study objectives
Change From Baseline in FEV1
Change From Baseline in FVC
Change From Baseline in Pre-dose Trough FEV1
+7 more

Side effects data

From 2015 Phase 4 trial • 88 Patients • NCT02125734
5%
Cough
2%
Headache
2%
Nasal congestion
2%
Nasopharyngitis
1%
Palpitations
1%
Pain in extremity
1%
Fluid retention
1%
Muscle spasms
1%
Hypertension
1%
Productive cough
1%
Dyspnoea
1%
Pruritus
1%
Renal pain
1%
Hypertriglyceridaemia
1%
Arthralgia
1%
Rhinorrhoea
1%
Nausea
1%
Peripheral swelling
1%
Bronchitis
1%
Herpes zoster
1%
Rhinitis
1%
Sinusitis
1%
Laceration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tiotropium
QVA149

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: QVA149Experimental Treatment1 Intervention
27.5/12.5 ug twice daily (b.i.d.) Single Dose Dry Powder Inhaler (SDDPI
Group II: QAB149Active Control1 Intervention
27.5 ug b.i.d.
Group III: NVA237Active Control1 Intervention
12.5 ug b.i.d.
Group IV: PlaceboPlacebo Group1 Intervention
b.i.d.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
QVA149
2016
Completed Phase 4
~14260

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,914 Previous Clinical Trials
4,252,176 Total Patients Enrolled
~77 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top