Phase 3
Completed N=1,216
Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation
Source: ClinicalTrials.gov NCT01610037 ↗Enrolled (actual)
1,216
Serious AEs
13.2%
Results posted
Jun 2016
Primary outcomePrimary: Number of Patients With Serious Adverse Events — 55; 55; 50 Participants
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
The study will assess the long-term safety of the fixed combination product QVA149 versus placebo and a standard of care treatment (tiotropium) in Chronic Obstructive Pulmonary Disease (COPD) patients with moderate to severe airflow limitation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Serious Adverse Events |
55; 55; 50 | — |
| SECONDARY Percentage of Patients With Composite Endpoint of All-cause Mortality, and Serious Cardio- and Cerebrovascular (CCV) Events. |
3.9; 2; 1 | — |
| SECONDARY Post-hoc Analysis: Percentage of Patients With Composite Endpoint of Cardiovascular Death and MACE |
1; 0.7; 0.7 | — |
| SECONDARY Change From Baseline in Pre-Dose Forced Expiratory Volume Over in Second (FEV1) |
0.1733; 0.1018; -0.0148; 0.1751; 0.0961; -0.0196 | — |
| SECONDARY Change From Baseline in Health Status as Measured by St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) |
-6.79; -6.12; -2.18 | — |
| SECONDARY Change From Baseline in Daily, Morning and Evening Symptom Scores |
-1.3478; -1.2283; -0.7683; -1.1688; -1.0669; -0.5641 | — |
| SECONDARY Change From Baseline in Percentage of Nights With 'no Nighttime Awakenings |
11.34; 10.66; 8.21 | — |
| SECONDARY Change From Baseline in Percentage of no Daytime Symptoms |
5.56; 4.72; 1.78 | — |
| SECONDARY Change From Baseline in Percentage of Days Able to Perform Usual Daily Activities. |
10.79; 6.54; 1.13 | — |
| SECONDARY Change From Baseline in 1 Hour Post-dose Forced Vital Capacity (FVC) Measurements |
0.3331; 0.2806; 0.0630; 0.3971; 0.3123; 0.0178 | — |
| SECONDARY Time to Premature Discontinuation |
NA; NA; NA | — |
| SECONDARY Change From Baseline in 1 Hour Post-dose FEV1 Measurements |
0.2064; 0.1567; 0.0281; 0.2883; 0.2077; 1.5827 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01610037). 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.