MOVE - A 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 Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT01996319 Phase 3 COMPLETED Results posted

This study is designed to assess the effect of QVA149 (110/50 ug q.d.) versus placebo on pulmonary function and average physical activity levels in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Details

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	COMPLETED
Enrolment	194
Start date	2014-04
Completion	2015-02

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

• QVA149
• Placebo

Primary outcomes

• Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo — Baseline, day 22, baseline day 36, day 57
  Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36
• Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level — Baseline, day 22, baseline day 36, day 57
  Average physical activity level is defined by average daily activity-related energy consumption \[Kcal/day\], measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36

Countries

Germany