A Study to Assess the Efficacy, Safety and Tolerability of Once-daily QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (GLEAM)

A 26-week treatment multi-center, randomized, double-blind, parallel-group, placebo and active controlled (open label) study to assess the efficacy safety and tolerability of QVA149 (110/50 µg q.d.) 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/2010/091/006103

Enrollment

2138

Registered

2010-12-31

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 (COPD)

Interventions

Intervention1: QVA149: delivered once daily via single-dose dry powder inhaler (SDPPI)throughout the study duration. Control Intervention1: NVA237: delivered once daily via SDDPI Control Intervention2

s proprietary device Control Intervention4: Placebo: delivered once daily via SDDPI

Eligibility

Inclusion criteria

Inclusion criteria: Male or female adults aged greater or equal to 40 yrs Smoking history of at least 10 pack years Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) Post-bronchodilator FEV1 less than 80 percent and greater than or 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: 1. Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1 2. Patients with concomitant pulmonary disease 3. Patients with a history of asthma 4. Any patient with lung cancer or a history of lung cancer 5. Patients with a history of certain cardiovascular co-morbid conditions 6. Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency 7. Patients in the active phase of a supervised pulmonary rehabilitation program 8. Patients contraindicated for inhaled anticholinergic agents and beta 2 agonists 9. Other protocol-defined inclusion/exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Superiority of once-daily QVA149 compared to both indacaterol and NVA237 in terms of trough FEV1 in patients with moderate to severe COPDTimepoint: 26 weeks	—

Secondary

Measure	Time frame
Superiority of once-daily QVA149 compared to placebo in terms of level of breathlessness, health-related quality of life, and rescue medication usedTimepoint: 26 weeks;Superiority of once-daily QVA149, NVA237 and indacaterol compared to placebo in terms of lung function at trough FEV1Timepoint: 26 weeks	—

Countries

Australia, Bulgaria, Canada, France, Germany, Guatemala, Hungary, Japan, Philippines, Poland, Russian Federation, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey, 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