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CTRI Number  CTRI/2020/12/030118 [Registered on: 30/12/2020] Trial Registered Prospectively
Last Modified On: 24/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy and safety study of Indacaterol, inhalation capsules 150 µg in patients with COPD 
Scientific Title of Study   International, open-label, randomized, comparative efficacy and safety study of Indacaterol, inhalation capsules 150 µg (LLC PSK Pharma, Russia) and Onbrez® Breezhaler®, inhalation capsules 150 µg (Novartis Pharma AG, Switzerland) in patients with COPD 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IND-5/19 Version:1.0 Date:15.01.2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S Sadgune  
Designation  overall Trial Coordinator 
Affiliation  Mudra Clincare 
Address  Room No. 2, 1st Floor, B Wing, Sector 18, Kamothe

Mumbai (Suburban)
MAHARASHTRA
410206
India 
Phone    
Fax    
Email  dr.sayalitarte@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S Sadgune  
Designation  overall Trial Coordinator 
Affiliation  Mudra Clincare 
Address  Room No. 2, 1st Floor, B Wing, Sector 18, Kamothe

Mumbai (Suburban)
MAHARASHTRA
410206
India 
Phone    
Fax    
Email  dr.sayalitarte@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr S Sadgune  
Designation  overall Trial Coordinator 
Affiliation  Mudra Clincare 
Address  Room No. 2, 1st Floor, B Wing, Sector 18, Kamothe

Mumbai (Suburban)
MAHARASHTRA
410206
India 
Phone    
Fax    
Email  dr.sayalitarte@gmail.com  
 
Source of Monetary or Material Support  
PSK Pharma LLC 2 Programmistov 4, premise 215, Dubna town, Moscow Region 141983 
 
Primary Sponsor  
Name  PSK Pharma LLC 
Address  2 Programmistov 4, premise 215, Dubna town, Moscow Region 141983 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Mudra Clincare  Plot No. 80, Sector - 8, Koparkhairane, Navi Mumbai-400709, Maharashtra, INDIA.  
 
Countries of Recruitment     India
Russian Federation  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Uma Mulay   Orchid Hospital  Department of Medicine, Room No. 2, 1st Floor, B Wing, Sector 18, Kamothe
Mumbai (Suburban)
MAHARASHTRA 		 7738664583

drumamulay@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Altezza Institutuional Ethics Committe, Shree Ashirwad Hospital, Dombivli, ,aharshtra, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J452||Mild intermittent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Tradename Indacaterol Generic name Indacaterol Pharmaceutical form Inhalation Powder Capsules Manufacturer PSK Pharma LLC, Russia   Study Dosing Regime 1 capsule (150 μg) for inhalation 1 time per day 
Comparator Agent  Tradename Onbrez® Breezhaler® Generic name Indacaterol Pharmaceutical form Inhalation Powder Capsules   Study Dosing Regime 1 capsule (150 μg) for inhalation 1 time per day 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. The presence of a signed Informed Consent Form of Patient Information Sheet (PIS) for participation in a clinical study.
2. Male and female patients aged 40–70 years old inclusive at the time of signing the Informed Consent Form of PIS.
3. A diagnosis of moderate-grade COPD, established according to the GOLD guidelines, 2018, at least 12 months before the screening visit.
4. Patients corresponding to group B, according to GOLD, 2018
 
 
ExclusionCriteria 
Details  1. Patients requiring initial treatment for COPD.
2. Hypersensitivity to indacaterol or any of the components of the drug.
3. Lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
4. Demand for excessive use of SABAs
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
FEV1 variation value   AT 86th day 
 
Secondary Outcome  
Outcome  TimePoints 
Dynamics of FEV1 indicator   at 28th, 56th and 86th Day 
Dynamics of the absolute PEF indicator   at 28th, 56th and 86th Day 
Dynamics of the total CAT score   at 28th, 56th and 86th Day 
 
Target Sample Size   Total Sample Size="136"
Sample Size from India="116" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/12/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/12/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="12" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Chronic Obstructive Pulmonary Disease (COPD) is a disease characterized by airflow restriction with the development of not completely reversible bronchial obstruction. Airflow restriction is progressing and is associated with an enhanced pathological inflammatory response of the respiratory tract to damaging particles or gases

To evaluate the efficacy of therapy with Indacaterol inhalation powder capsules in comparison with Onbrez® Breezhaler® inhalation powder capsules in patients with COPD.

To evaluate the safety of therapy with Indacaterol inhalation powder capsules in comparison with Onbrez® Breezhaler® inhalation powder capsules in patients with COPD.

To evaluate the effect of Indacaterol inhalation powder capsules in comparison with Onbrez® Breezhaler® inhalation powder capsules on the quality of life of patients with COPD.
 
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