Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in COPD Patients With Moderate to Severe Airflow Limitation

A Placebo and Active Controlled Study to Assess the Long-term Safety of Once Daily QVA149 for 52 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients With Moderate to Severe Airflow Limitation - RADIATE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/12/003207

Enrollment

1224

Registered

2012-12-12

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: Drug: QVA149 (QVA149 110/50Î¼g): QVA149 110/50 Âµg will be supplied as capsules in blister packs for once daily inhalation using the Novartis Concept1 SDDPI for 1 year. Control Interven

Eligibility

Inclusion criteria

Inclusion criteria: 1.Smoking history of at least 10 pack years 2.Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate to severe airflow limitation as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2011) 3.Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)less then 80 percent and greater than equal to 30percent of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) less than 70percent. 4.Modified Medical Research Council questionnaire grade of 2 or higher

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 contraindicated for inhaled anticholinergic agents and Î²2 agonists. 8.Patients in the active phase of a supervised pulmonary rehabilitation program.

Design outcomes

Primary

Measure	Time frame
1.Overall serious adverse event rate. The overall rate of serious adverse events reported from initiation through 30 days post last dose will be analyzed. Timepoint: 56 weeks	—

Secondary

Measure	Time frame
1.Electrocardiogram.Data from the electrocardiograms will be summarized by treatment at all times.Timepoint: Weeks 1, 26 and 52;2.â?¢ Health Status as measured by Saint Georges Respiratory Questionnaire (SGRQ-C) for Chronic Obstructive Pulmonary Disease (COPD) patientsTimepoint: 52 weeks;Impairment of health status daily, morning and evening symptom scoresTimepoint: 52 weeks;Percentage of nights with no nighttime awakeningsTimepoint: 52 weeks	—

Measure

Time frame

1.Electrocardiogram.Data from the electrocardiograms will be summarized by treatment at all times.Timepoint: Weeks 1, 26 and 52;2.â?¢ Health Status as measured by Saint Georges Respiratory Questionnaire (SGRQ-C) for Chronic Obstructive Pulmonary Disease (COPD) patientsTimepoint: 52 weeks;Impairment of health status daily, morning and evening symptom scoresTimepoint: 52 weeks;Percentage of nights with no nighttime awakeningsTimepoint: 52 weeks

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Countries

Argentina, Colombia, Croatia, Dominican Republic, Estonia, Guatemala, Hungary, India, Ireland, Israel, Latvia, Lithuania, Mexico, Panama, Poland, Republic of Korea, Russian Federation, Serbia, Slovenia, Turkey, United Kingdom, Venezuela (Bolivarian Republic of)

Contacts

Public ContactMurugananthan K

Novartis Healthcare Private Limited,

murugananthan.k@novartis.com022-24958545

Outcome results

None listed

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