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CTRI Number  CTRI/2017/10/010024 [Registered on: 06/10/2017] Trial Registered Prospectively
Last Modified On: 30/07/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of the efficacy and safety of Tiotropium bromide,in patients with COPD. 
Scientific Title of Study   An open-label, multicentre, randomized, comparative study of the efficacy and safety of Tiotropium bromide, inhalation powder capsules, 18 µg (Sava Healthcare Limited, India), versus Spiriva®, inhalation powder capsules, 18 µg (Boehringer Ingelheim Pharma GmbH & Co. KG, Germany) in patients with COPD. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
МА/1215-6/1 Version No.: 1.0, Dated: 25/01/2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amit Bhatt 
Designation  Director 
Affiliation  Nexus Clinical Research (India) Ltd. 
Address  Nexus Clinical Research (India) Ltd 32A Nexus Centre For Clinical Excellence, Shiravane Road Service Industry Sector 1 Mumbai Pune Highway Nerul, Navi Mumbai India

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  9167243914  
Fax  09167243914  
Email  hbo@nexuscro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Bhatt 
Designation  Director 
Affiliation  Nexus Clinical Research (India) Ltd. 
Address  Nexus Clinical Research (India) Ltd 32A Nexus Centre For Clinical Excellence, Shiravane Road Service Industry Sector 1 Mumbai Pune Highway Nerul, Navi Mumbai India

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  9167243914  
Fax  09167243914  
Email  hbo@nexuscro.com  
 
Details of Contact Person
Public Query  
Name  Dr Mangesh khadakban 
Designation  Clinical Operations 
Affiliation  Nexus Clinical Research (India) Ltd. 
Address  Nexus Clinical Research (India) Ltd 32A Nexus Centre For Clinical Excellence, Shiravane Road Service Industry Sector 1 Mumbai Pune Highway Nerul, Navi Mumbai India

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  9167243914  
Fax    
Email  mangesh.khadakban@nexuscro.com  
 
Source of Monetary or Material Support  
Rus Biopharm LLC 664009, Russian Federation, Irkutsk, Ul. Shiryamova, 36, Office 206  
 
Primary Sponsor  
Name  Rus Biopharm LLC 
Address  664009, Russian Federation, Irkutsk, Ul. Shiryamova, 36, Office 206  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NEXUS CLINICAL RESEARCH INDIA LTD  Nexus Clinical Research (India) Ltd. Nexus Solitaire, Plot No. 4 A, Sector -09, Nerul (E), Navi Mumbai 400706, 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 S Behera   Hi Tech Medical College & Hospital   Department of Medicine Second floor Room No. 02 Division Pulmonary, Pandara Rasulgarh Bhubaneshwar Odisha 751025
Khordha
ORISSA 		 9439129178

behera.saiprasanna82@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Hi Tech Medical College and Hospital Institutional Ethics Committee   Approved 
Institutional Ethics Committer Ashirwad Ethics Committee, Ulhasnagar, India  Submittted/Under Review 
Sparsh Institutional Ethics Committee, Bhubhaneshwar, Odisha   Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  In patients with COPD,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Spiriva® Inhalation powder capsules, 18 μg  Manufacturer Boehringer Ingelheim Pharma GmbH & Co. KG, Germany Study dosing regimen 1 capsule (18 µg) per inhalation once daily for 84 days  
Intervention  Tiotropium bromide Inhalation powder capsules, 18 μg, supplied with an inhaler   Manufacturer Sava Healthcare Limited, India. Study dosing regimen 1 capsule (18 µg) per inhalation once daily for 84 days.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1 Male and female patients 40 to 75 years of age.
2 Diagnosis of COPD established according to the GOLD guidelines (2015) not less than 12 months prior to the screening visit.
3 COPD assessment test (CAT) score ≥ 10.
4 Number of exacerbations per year: 0 – 1.
5 Patient’s consent to use reliable methods of contraception throughout the study and for 3 weeks after the study
 
 
ExclusionCriteria 
Details  1 Hypersensitivity to atropine, its derivatives (ipratropium, oxitropium) or to any component of the study drugs.
2 Lactose intolerance, lactase deficiency, or glucose - galactose malabsorption.
3 Use of oral or parenteral glucocorticoids (GC) within 2 months prior to the screening visit (3 months for prolonged-release parenteral GC).
4 A history of cystic fibrosis, bronchiectasis, pneumoconiosis, or other impairment of pulmonary ventilation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
FEV1   change at Visit 4  
 
Secondary Outcome  
Outcome  TimePoints 
FEV1  Changes at Visits 2, 3, and 4 
Absolute PEF value   Changes in the absolute PEF value by Visits 2, 3, and 4. 
Total CAT score   Changes in the total CAT score by Visits 2, 3, and 4. 
Dyspnoea severity score   Changes in the dyspnoea severity score assessed with the MRC scale by Visits 2, 3, and 4. 
Proportion of patients with exacerbated disease   Proportion of patients with exacerbated disease at Visits 2, 3, and 4  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="134" 
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   N/A 
Date of First Enrollment (India)
Modification(s)  		 21/11/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/11/2017 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="19" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The study will be conducted as an open-label, multicentre, randomized, comparative trial.

The total duration of the study for each patient will not exceed 109 days, of which the duration of screening will not exceed
14 days, the duration of the treatment period - 84 days, and the duration of the follow-up period - 11 days.

Visits

Visit 0 (screening, Day -14 ... -1); Visit 1 (randomization, Day 1) ; Visit 2 (interim visit, 28 ± 2 days); Visit 3 (interim visit, 56 ± 2 days); Visit 4 (completion of therapy, 86 ± 2 days); Visit 5 (telephone call, 93 ± 2 days).

The 1st group of patients will receive 1 inhalation (one capsule) of Tiotropium bromide, inhalation powder capsules, 18 µg (Sava Healthcare Limited, India), once daily (at the same time) for 84 days, performed using an inhaler.

The 2nd group of patients will receive 1 inhalation (one capsule) of Spiriva®, inhalation powder capsules, 18 µg (Boehringer Ingelheim Pharma GmbH & Co. KG, Germany), once daily (at the same time) for 84 days, performed using an inhaler. 

 
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