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.

Chronic Obstructive Pulmonary Disease Clinical Trial

— MOVE  

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01996319
• Other study ID #: CQVA149ADE03
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 15, 2013
• Last updated: January 27, 2014
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2014
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• QVA149
QVA149 (110/50 µg) once a day via Breezhaler® device
• Placebo
Placebo once a day via Breezhaler® device

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Aschaffenburg
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Cottbus	Sachsen
Germany	Novartis Investigative Site	Dueren
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Euskirchen
Germany	Novartis Investigative Site	Geesthacht
Germany	Novartis Investigative Site	Grosshansdorf
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Höchstadt
Germany	Novartis Investigative Site	Koblenz	NRW
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Köln
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Lübeck
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Münster
Germany	Novartis Investigative Site	Neunkirchen
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Rheine
Germany	Novartis Investigative Site	Rüdersdorf
Germany	Novartis Investigative Site	Saarbruecken
Germany	Novartis Investigative Site	Teterow
Germany	Novartis Investigative Site	Wedel
Germany	Novartis Investigative Site	Wiesloch

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak inspiratory capacity (IC) comparison between QVA149 and Placebo	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.	Baseline and day 21	No
Primary	Comparison of QVA149 versus placebo with respect to average physical activity level	Average physical activity level is defined by average daily activity-related energy consumption [Kcal/day], measured via Actinography device.	Baseline, day 15, baseline day 35, day 56	No
Secondary	Comparison of QVA149 vs. placebo on the average number of steps per day	The average number of steps per day will be measured via Actinography device.	Baseline, day 15, baseline day 35, day 56	No
Secondary	Comparison of QVA149 versus placebo on the duration of at least moderate activity per day	Least moderate activity (defined as 3,5-7kcal/min) will be measured via Actinography device.	Baseline, day 15, baseline day 35, day 56	No
Secondary	Peak IC comparison between QVA149 and Placebo.	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.	Day 1	No
Secondary	Trough IC comparison between QVA149 and Placebo	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.	Day 20	No
Secondary	Peak forced expiratory volume 1 (FEV1) comparison between QVA149 and Placebo	FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.	Day 1	No
Secondary	Trough FEV1 comparison between QVA149 and placebo	FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.	Day 20	No