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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2012/12/003207
• Date of registration: 12-12-2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Healthcare Pvt Ltd
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 15-01-2013
• Target sample size: 1224
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=5363
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 3

Countries of recruitment

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

• Name: Murugananthan K
• Affiliation: Novartis Healthcare Private Limited,

• Name: Murugananthan K
• Affiliation: Novartis Healthcare Private Limited,

Key inclusion & exclusion 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: 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 β2 agonists.

8.Patients in the active phase of a supervised pulmonary rehabilitation program.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Chronic Obstructive Pulmonary Disease (COPD)

Intervention(s)

Intervention1: Drug: QVA149
(QVA149 110/50μg): QVA149 110/50 µg will be supplied as capsules in blister packs for once daily inhalation using the Novartis Concept1 SDDPI for 1 year.
Control Intervention1: Drug: Tiotropium
(Tiotropium 18 ìg plus): Tiotropium 18 µg will be supplied as capsules in blister packs for once daily inhalation using the HandiHaler SDDPI for 1 year.
Control Intervention2: Drug: Placebo
Placebo (50percent Concept1, 50 percent HandiHaler): Placebo to QVA149A and Tiotropium will be supplied in the appropriate capsule in blister packs for use in either the Novartis Concept1 SDDPI or the HandiHaler SDDPI for 1 year..

Primary Outcome(s)

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 Outcome(s)

Percentage of nights with no nighttime awakeningsTimepoint: 52 weeks

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

Secondary ID(s)

NCT01610037

CQVA149A2339, Version:00 dated: 14 May 2012

Source(s) of Monetary Support

Novartis Pharma AG, Basel, Switzerland.

Ethics review

Status: Approved
Approval date: 08/11/2012
Contact:

Manipal University Ethics Committee,KMC Hospital, Dr. Anand R

Status: Approved
Approval date: 20/11/2012
Contact:

Anubhav Independent Ethics Committee, Ahemadabad,Dr. Ajay Kumar Jain

Status: Approved
Approval date: 05/12/2012
Contact:

Institutional Ethics Committee, Global Hospital,Dr. Mohmmad Samiuddin

Status: Approved
Approval date: 12/12/2012
Contact:

Swasthya Kalyan Ethics committee, Jaipur,Dr. Ashish Malpani

Status: Approved
Approval date: 14/12/2012
Contact:

Sri Bala Medical Centre & Hospital Pvt.Ltd, Dr. Srikanth K

Status: Approved
Approval date: 15/12/2012
Contact:

Ethics Committee, BREATHE Trust, Leela More Chest Clinic,Dr. Ravindra Sarnaik

Status: Approved
Approval date: 17/12/2012
Contact:

Institutional ethics committee Apex Hospitals Pvt. Ltd,Dr. Vipul Khandelwal

Status: Approved
Approval date: 19/12/2012
Contact:

Cerebral Indepandent Review Board, Hyderbad,Dr. Sandeep Saboo

Status: Approved
Approval date: 19/12/2012
Contact:

Independent Human Ethics committee, Kerala,Dr. Mathew Thomas

Status: Approved
Approval date: 26/12/2012
Contact:

institutional Ethics Committtee,Christian Medcial College Vellore Association, Dr D J Christopher

Status: Approved
Approval date: 04/01/2013
Contact:

Ethics Committee Allergy Asthma Associates, Dr. PA Mahesh

Status: Approved
Approval date: 14/01/2013
Contact:

ETHICS COMMITTEE,SP Medical College & Associated Group of Hospital Bikaner,Dr. Surendra Kumar

Status: Approved
Approval date: 19/01/2013
Contact:

Institutional Ethics Committee,TB & Chest Hospital, Dr. Anthony Mesquita

Status: Approved
Approval date: 22/01/2013
Contact:

Sanjeevani Ethics Committee, Jaipur,Dr. Manish Jain

Status: Approved
Approval date: 31/01/2013
Contact:

Nagpur Independent Ethics Committee,Dr. Shantanu Shengupta

Status: Approved
Approval date: 07/02/2013
Contact:

Ethics Committee Bangalore Medical College and Research Institute,Dr. C. Nagaraja

Status: Approved
Approval date: 03/06/2013
Contact:

Sri Ventakeshwara Hospital, Ethics Comittee, Dr. Vijaykumar Narayanappa

Status: Not Approved
Approval date:
Contact:

Ethics Committee, Osmania Medical Hospital, Dr. Srinivasa Rao

Status: Not Approved
Approval date:
Contact:

Institutional board Chest Research Foundation, Dr. Sundeep Salvi

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, Pune, Ruby Hall