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

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: CTRI/2010/091/000665
• Lead Sponsor: Novartis Healthcare Pvt Ltd

Brief Summary

Target number of patients is 200.Planned FPFV in India is 2nd August 2010.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-19
• Last Update Posted: 2013-07-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2200

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Superiority of QVA149 over NVA237 in terms of rate of COPD exacerbations	52 weeks

Secondary Outcome Measures

Name	Time	Method
Superiority of QVA149 over NVA237 in terms of time to first COPD exacerbation	52 weeks
Safety and tolerability of QVA149 versus NVA237 assessed by adverse events, electrocardiogram (ECG), laboratory tests, and vital signs	52 weeks

Trial Locations

Locations (16)

Kovai Medical Centre & Hospital (KMCH); 🇮🇳 Coimbatore, TAMIL NADU, India

Allergy, Asthma & Chest Centre; 🇮🇳 Mysore, KARNATAKA, India

Chest Research Foundation; 🇮🇳 Pune, MAHARASHTRA, India

Coimbatore Chest Clinic; 🇮🇳 Coimbatore, TAMIL NADU, India

Get Well Hospital & Research Institute; 🇮🇳 Nagpur, MAHARASHTRA, India

Gyanpushp Research Centre for Chest & Allergy Diseases,; 🇮🇳 Indore, MADHYA PRADESH, India

Health and Research Centre; 🇮🇳 College, P.O., India

Institute of Pulmocare and Research; 🇮🇳 Kolkata, WEST BENGAL, India

Kunal Institute of Medical Specialities Pvt Ltd; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

PSG Hospital, Professor & Head of TB & Respiratory Diseases; 🇮🇳 Coimbatore, TAMIL NADU, India

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Kovai Medical Centre & Hospital (KMCH)

🇮🇳Coimbatore, TAMIL NADU, India

Dr. Vallandramam Ranganathan Pattabhiraman

Principal investigator

vr.pattabhiraman@gmail.com