A Study to Assess the Long-term Safety of QVA149

A multicenter, randomized, double-blind, placebo controlled study, to assess the long term safety of 52 weeks treatment with QVA149 (110 microgram indacaterol / 50 microgram glycopyrrolate) in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001029

Enrollment

339

Registered

2010-07-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic Obstructive Pulmonary Disease

Interventions

Intervention1: QVA149: 150 microgram capsules for oral inhalation,once daily, delivered by an SDDPI throughout the study duration. Control Intervention1: Placebo: once daily same as the interventional

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1) Male or female adults aged greater than eual to 40 yrs 2) Smoking history of at least 10 pack years 3) Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) 4) Post-bronchodilator FEV1 less than 80 percent and greater than equal to 30 percent of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) less than 70 percent

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1 . Patients with concomitant pulmonary disease Patients with a history of asthma. Any patient with lung cancer or a history of lung cancer . Patients with a history of certain cardiovascular co-morbid conditions. Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency . Patients in the active phase of a supervised pulmonary rehabilitation program . Patients contraindicated for inhaled anticholinergic agents and â2 agonists. Other protocol-defined inclusion/exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
1) Safety/tolerability of treatment with once-daily QVA149 based on adverse event reporting rate.Timepoint: 1)Time Frame: 52 weeks	—

Secondary

Measure	Time frame
1)Safety of QVA149 with regard to vital signs, ECG, and laboratory evaluations.Timepoint: 1)Time Frame: 52 weeks;2)To compare the bronchodilator effect of QVA149 with placebo assessed by mean FEV1 at 15 and 45 minutes pre-doseTimepoint: 2)Time Frame: 52 weeks	—

Countries

Canada, France, Hungary, India, Latvia, Lithuania, Romania, South Africa, Turkey, United Kingdom

Contacts

Public ContactMurugananthan K

murugananthan.k@novartis.com022-24958545

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026