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CTRI Number  CTRI/2023/12/060605 [Registered on: 21/12/2023] Trial Registered Prospectively
Last Modified On: 24/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate the safety and efficacy of Indacaterol, Mometasone, Glycopyrronium Dry powder inhaler in Asthma patients. 
Scientific Title of Study   An open label single arm, multicentric, prospective, phase IV study to evaluate the safety and effectiveness of Indacaterol/ Mometasone/ Glycopyrronium DPI in the management of Asthma patients 
Trial Acronym  OASIS Study 
Secondary IDs if Any  
Secondary ID  Identifier 
GPL/CT/2023/002/IV, Version 1.0 Dated 28-Mar-2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sumit Bhushan  
Designation  Deputy General Manager-Clinical Studies Global Medical Affairs  
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Pharmaceuticals Ltd., Glenmark Corporate Enclave, BD Sawant Marg, Chakala, Off WE Highway, Andheri East

Mumbai (Suburban)
MAHARASHTRA
400099
India 
Phone  08800352225  
Fax    
Email  Sumit.Bhushan@glenmarkpharma.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sumit Bhushan  
Designation  Deputy General Manager-Clinical Studies Global Medical Affairs  
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Pharmaceuticals Ltd., Glenmark Corporate Enclave, BD Sawant Marg, Chakala, Off WE Highway, Andheri East

Mumbai (Suburban)
MAHARASHTRA
400099
India 
Phone  08800352225  
Fax    
Email  Sumit.Bhushan@glenmarkpharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Nidhi Singh 
Designation  Head Clinical Operations 
Affiliation  Clinical Research Network India Pvt Ltd 
Address  B-806,807, Advant Navis Business Park #Plot #7, Noida-Greater Noida Expressway Sector 142, Noida, Delhi-NCR

Gautam Buddha Nagar
UTTAR PRADESH
201305
India 
Phone  9695237796  
Fax    
Email  nidhisingh@crnindia.org  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Ltd., Glenmark Corporate Enclave, BD Sawant Marg, Chakala, Off WE Highway, Andheri East Mumbai (Suburban) MAHARASHTRA 400099 India  
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Corporate Enclave, BD Sawant Marg, Chakala, Off WE Highway, Andheri (E), Mumbai – 400099  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Clinical Research Network India   B-806 & 807, Advant Navis Business Park, Plot #7, Noida-Greater Noida Expressway, Sector 142, Noida, Delhi-NCR, Uttar Pradesh 201305  
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saurabh Karmakar   All India Institute of Medical Sciences   Dept. of Pulmonary Medicine, Aurangabad Rd., Phulwari sharif, Patna, Bihar -801507 India Patna BIHAR
Patna
BIHAR 		 7783892746

drkarmakar01@gmail.com 
Dr Anjali R Nath   Citizen Hospital   Dept. of medicine #14, 2nd Main, Dispensary Road, Kalasipalya, Bangalore-560002
Belgaum
KARNATAKA 		 9995395041

anjali.rnadh@gmail.com 
Dr Suresh G Bhate  Jeevan Rekha Hospital   Near Nagshanti Motors Showroom, Veer Chambers, Opp. Civil Hospital Road, Belagavi- 590002 Belgaum KARNATAKA
Belgaum
KARNATAKA 		 9380840560

drsureshgbhate@gmail.com 
Dr Vinod Kumar Kapoor  New Leelamani Hospital   14/116, C-1, Parade Chauraha, Civil Lines Kanpur- 208001, UP, India Kanpur Nagar UTTAR PRADESH
Kanpur Nagar
UTTAR PRADESH 		 09555989176

drvinodkumarkapoor@gmail.com 
Dr Vijaykumar Bhagwan Barge   Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and General Hospital   Medicine Department, CPR Hospital Dasara chowk, Bhausingji Road, Town hall, Kolhapur, Maharasthtra 416012
Kolhapur
MAHARASHTRA 		 7969792775

drvijaybarge12@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee Jeevan Rekha Hospital   Approved 
IEC, Citizen Hospital   Approved 
Institute Ethics Committee-AIIMS patna  Approved 
Institute Ethics Committee-Leelamani Hospital   Approved 
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje Hospital, Kolhapur Institutional Ethics Committee 2 (RCSMGMCIEC2)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J45||Asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Indamet G®  Indacaterol (as acetate 150 mcg + Mometasone furoate 160 mcg+ Glycopyrronium 50 mcg) powder for inhalation 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  a.Patients ≥18 years of age with a documented physician diagnosis of Asthma
b. Symptomatic patients on ongoing maintenance therapy with ICS/LABA or ICS/FOR
c. ACQ-5 score ≥ 1.5 at baseline.
d. History of one or more asthma exacerbations in last one year.
e. Ability to use dry powder inhaler independently and correctly in view of the investigator.
f. Patient is willing to sign a written informed consent form and agree to follow up on a regular basis as specified in the protocol. 
 
ExclusionCriteria 
Details  a. History of current hospitalization with life threatening condition or patients with acute exacerbation of asthma (acute condition).
b. Smoking history of more than 10 pack-years.
c. Ongoing treatment with Triple therapy i.e. ICS/LABA/LAMA.
d. Subjects with any life threatening condition.
e. Women of childbearing potential are not restricted in this study, however it is expected that the investigator will assess the risks and benefits of the assigned treatment as per the product label(s) and discuss this with any
women of childbearing potential prior to providing the patient with the prescription for the assigned treatment.
f. Subjects with history of hypersensitivity to the active substance or to any of its excipients of study drug. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the safety of IND/MF/GLY DPI in treatment of Asthma in Indian population

Number of patients with any drug related treatment emergent adverse events (TEAEs).
Number of patients with TEAEs
Number of patients with serious TEAEs (STEAEs) 		 At week 12 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of IND/MF/GLY DPI in treatment of Asthma in Indian population
Mean change in Trough FEV1 from baseline
Mean change in ACQ-5 score from baseline
Percentage change in ACQ-5 score at week 4 and 12 from baseline. 		 At week 12 
 
Target Sample Size   Total Sample Size="182"
Sample Size from India="182" 
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 4 
Date of First Enrollment (India)   29/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The study is a prospective, open label, multicentre, single arm, interventional, phase IV study to evaluate the safety and effectiveness of IND/MF/GLY DPI in the management of Asthma among Indian patients. Adult patient with uncontrolled Asthma will be enrolled in the study. Clinical diagnosis of Asthma will be as per the standard definition by GINA 2022. A detailed medical history will be obtained and also physical examination will be conducted for each patient by the study investigators. Treatment duration is 12 weeks and patients will be followed-up till the end of study. 
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