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Bronchodilator

QVA149 dose 1 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 day1, 29, 57, 85, 141, 197, 253, 309, and 365
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial

Summary

This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 in patients with moderate to severe airflow limitation.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day1, 29, 57, 85, 141, 197, 253, 309, and 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and day1, 29, 57, 85, 141, 197, 253, 309, and 365 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients With Adverse Events, Serious Adverse Events, and Death
Secondary study objectives
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
Change From Baseline in FVC Measurement at All Post-baseline Time Points
Change From Baseline in Mean Total Daily Symptom Scores
+4 more

Side effects data

From 2015 Phase 4 trial • 88 Patients • NCT02125734
5%
Cough
2%
Nasal congestion
2%
Headache
2%
Nasopharyngitis
1%
Pain in extremity
1%
Palpitations
1%
Productive cough
1%
Fluid retention
1%
Muscle spasms
1%
Hypertension
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

3Treatment groups
Experimental Treatment
Active Control
Group I: QVA149 dose 2Experimental Treatment1 Intervention
QVA149 27.5/25 μg capsules
Group II: QVA149 dose 1Experimental Treatment1 Intervention
QVA149 27.5/12.5 μg capsules
Group III: QAB149Active Control2 Interventions
QAB149 75 μg capsules
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
2,901 Previous Clinical Trials
4,207,125 Total Patients Enrolled
~47 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
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