Effect of QVA149 Versus NVA237 on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations

A 52-week treatment, multi-center, randomized, double-blind, parallel-group,active controlled study to evaluate the effect of QVA149 (110/50 microgram o.d.) vs NVA237 (50 microgram o.d.) and open-label tiotropium (18 microgram o.d.) on COPD exacerbations in patients with severe to very severe chronic obstructive pulmonary disease (COPD)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000665

Enrollment

2200

Registered

2010-07-29

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: Experimental: 110/50 ìg delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of QAB149 110 ìg and NVA237 50 ìg once daily throughout th

Eligibility

Inclusion criteria

Inclusion criteria: Male or female adults aged greater than or equal to 40 yrs Severe or very COPD [Stage III or IV as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008] Smoking history of at least 10 pack years Post-bronchodilator FEV1 less than 50 percent of the predicted normal value and post- bronchodilator FEV1 or FVC less than 70percent Documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and or antibiotics

Exclusion criteria

Exclusion criteria: Patients requiring long term oxygen therapy (greater than 15 h a day) on a daily basis for chronic hypoxemia Patients who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 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 Other protocol-defined inclusion or exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
1.Superiority of QVA149 over NVA237 in terms of rate of COPD exacerbationsTimepoint: 52 weeks	—

Secondary

Measure	Time frame
Safety and tolerability of QVA149 versus NVA237 assessed by adverse events, electrocardiogram (ECG), laboratory tests, and vital signsTimepoint: 52 weeks;Superiority of QVA149 over NVA237 in terms of time to first COPD exacerbationTimepoint: 52 weeks	—

Countries

Austria, Brazil, Canada, Colombia, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Netherlands, Norway, Philippines, Poland, Russian Federation, Slovakia, Spain, United Kingdom, United States of America

Contacts

Public ContactMurugananthan K

murugananthan.k@novartis.com022-24958545

Outcome results

None listed

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