Phase 3
Completed N=615
A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation
Source: ClinicalTrials.gov NCT01682863 ↗Enrolled (actual)
615
Serious AEs
12.2%
Results posted
Mar 2016
Primary outcomePrimary: Number of Patients With Adverse Events, Serious Adverse Events, and Death — 26; 25; 24; 139 Number of Patients
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events, Serious Adverse Events, and Death |
26; 25; 24; 139; 142; 139 | — |
| SECONDARY Time to Premature Discontinuation of Treatment |
384.0; NA; NA | — |
| SECONDARY Change From Baseline in Pre-dose Trough FEV1 |
0.164; 0.194; 0.109; 0.178; 0.199; 0.107 | — |
| SECONDARY Change From Baseline in 1 Hour Post-dose FEV1 Measurements |
0.166; 0.178; 0.122; 0.257; 0.287; 0.173 | — |
| SECONDARY Change From Baseline in FVC Measurement at All Post-baseline Time Points |
0.316; 0.349; 0.248; 0.375; 0.440; 0.280 | — |
| SECONDARY Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation |
23.5; 24.9; 27.0 | — |
| SECONDARY Change From Baseline in Mean Total Daily Symptom Scores |
-1.57; -1.56; -1.31 | — |
| SECONDARY Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period |
-1.89; -1.62; -1.73 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female adults aged ≥40 years
- Patients with stable COPD according to GOLD strategy (GOLD 2011).
- Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
- Patients with an mMRC ≥ grade 2
Exclusion Criteria
- History of long QT syndrome or prolonged QTc
- Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.
- Patients with Type I or uncontrolled Type II diabetes
- Patients with a history of asthma or have concomitant pulmonary disease
- Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible
- Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety
- Other protocol defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01682863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.