Efficacy, safety and tolerability of the co-administration of NVA237 + indacaterol once daily vs. indacaterol once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-005673-23-GR
• Lead Sponsor: ovartis Pharma Service AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-02
• Last Update Posted: 4 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1. Patients with moderate to severe stable COPD (Stage II or Stage III) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
2. Patients with a post-bronchodilator FEV1 = 30 % and/or <80 % of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at screening.
3. Current or ex-smokers who have a smoking history of at least 10 pack years
4. Symptomatic patients according to daily diary data.

Other protocol defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225

Exclusion Criteria

1. Pregnant or nursing (lactating) women.
2. Women of child-bearing potential.
3. Patients with Type I or uncontrolled Type II diabetes.
4. Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia method) is prolonged
5. Patients with paroxysmal (e.g. intermittent) atrial fibrillation
6. Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)

Other protocol defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified