Randomized, Double-blind, Placebo-controlled, Multicenter, Cross-over Study to Assess the Effects of a 3 Week Therapy Each With QVA149 Versus Placebo on Pulmonary Function and Average Physical Activity Levels in Patients With COPD.
Source: ClinicalTrials.gov NCT01996319 ↗Summary
Linked Publications
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Effects of indacaterol/glycopyrronium (QVA149) on lung hyperinflation and physical activity in patients with moderate to severe COPD: a randomised, placebo-controlled, crossover study (The MOVE Study).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo |
0.3790; 0.1769 | <0.0001 sig |
| PRIMARY Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level |
5.1063; -31.6063 | 0.0399 sig |
| SECONDARY Change in the Comparison of QVA149 vs. Placebo on the Average Number of Steps Per Day |
30.7; -320.7 | — |
| SECONDARY Change in the Duration of at Least Moderate Activity Per Day Comparison of QVA149 Versus Placebo |
-5.5; -13.0 | — |
| SECONDARY Change From Baseline in Peak IC Comparison Between QVA149 and Placebo on Day 1. |
0.486; 0.207 | — |
| SECONDARY Change From Baseline in the Trough IC Comparison Between QVA149 and Placebo |
0.210; -0.035 | — |
| SECONDARY Peak Forced Expiratory Volume 1 (FEV1) Comparison Between QVA149 and Placebo at Day 1 |
0.347; 0.111 | — |
| SECONDARY Trough FEV1 Comparison Between QVA149 and Placebo After 22 Days |
0.245; -0.058 | — |
Eligibility Criteria
Inclusion Criteria
Patients with stable COPD according to the current GOLD guidelines (GOLD 2013). Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs)..
Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥40% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC <0.70
Exclusion Criteria
Patients with conditions contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof, anticholinergics, long and short acting beta2 agonists, sympathomimetic amines, lactose or any of the other excipients Patients who have a clinically significant ECG abnormality at Visit 1, who in the judgment of the investigator would be at potential risk if enrolled into the study.
Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at baseline and screening visits, with a resting ventricular rate < 100/min.
Patients with Type I or uncontrolled Type II diabetes and patients with a history of blood glucose levels consistently outside the normal range Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention.
Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with non-melanoma skin carcinoma may be considered for the study.
Patients with a body mass index (BMI) of more than 40 kg/m2. Women who are pregnant or breast feeding Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening.
Patients who have had a respiratory tract infection within 4 weeks prior to screening.
Patients with any history of asthma. Patients with concomitant pulmonary disease Patients with clinically significant bronchiectasis. Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01996319) and the linked publication. 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.