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)

Phase 1

• 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-ES
• Lead Sponsor: ovartis Farmacéutica S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-29
• Study Completion: 2013-01-08
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1.Male and female adults aged ?40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
2.Patients with moderate to severe stable COPD (Stage II or Stage III) according to the current GOLD Guidelines (GOLD, 2010).
3.Patients with a post-bronchodilator FEV1 ? 30 % and/or <80 % of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at screening.
[Post-bronchodilator refers to 1 h after sequential inhalation of 84 µg ipratropium bromide (or equivalent dose) and 400 µg salbutamol (or equivalent dose)].
4.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 years, or ½ pack/day x 20 years).
5.Symptomatic patients according to daily diary data, between the screening visit (Visit 2) and the randomization visit (Visit 3) with a total symptom score of 1 or more on at least 4 of the last 7 days prior to randomization (Visit 3).
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