| CTRI Number |
CTRI/2023/10/058675 [Registered on: 16/10/2023] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the safety and effectiveness of Glycopyrronium / Formoterol fumarate /
Budesonide Triple Therapy in the management of Chronic Obstructive Pulmonary Disease. |
|
Scientific Title of Study
|
An Open label SIngle arm, Multicentric, PRospective, Phase IV study to
evaluate the Safety and EFfectiveness of GlycOpyrronium/ FoRmoterol
fumarate / Budesonide triple therapy (TT) in the management of COPD
patiEnts.(AIR-FORCE Study) |
| Trial Acronym |
AIR-FORCE study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No.: GPL/CT/2022/010/IV, V 3.0 Dated 21-April-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) MAHARASTRA
Mumbai (Suburban)
MAHARASHTRA
400099
India |
| Phone |
8800352225 |
| 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) MAHARASTRA
Mumbai (Suburban)
MAHARASHTRA
400099
India |
| Phone |
8800352225 |
| 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 |
| Address |
B-806-807, Advant Nvais Business park , Plot#7 , Noida-Greater Noida Expressway , sector 142 Gautam Budh Nagar
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 (E), Mumbai – 400099 |
|
|
Primary Sponsor
|
| Name |
Glenmark Pharmaceuticals Ltd |
| Address |
Glenmark Pharmaceuticals Ltd.
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 = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deependra Kumar Rai |
All India Institute of Medical Sciences |
Dept. of Pulmonary Medicine, Aurangabad Rd., Phulwari sharif, Patna,
Bihar -801507
India
Patna
BIHAR |
7500411360
drdeependrakumarrai@gmail.com |
| Dr Anjali R Nath |
Citizen Hospital |
#14, 2nd Main, Dispensary Road, Kalasipalya, Bangalore-560002
Bangalore
KARNATAKA |
9995395041
anjali.rnadh@gmail.com |
| Dr Amit Bhate |
Jeevan Rekha Hospital |
Consultant Physician, Near Nagshanti Motors Showroom, Veer Chambers,
Opp. Civil Hospital Road,
Belagavi- 590002
Belgaum
KARNATAKA |
9667177125
dr.amitsureshbhate@gmail.com |
| Dr Bharat Mehrotra |
New Leelamani Hospital |
Consultant Pulmonologist, 14/116, C-1, Parade Chauraha, Civil Lines
Kanpur- 208001,
UP, India
Kanpur Nagar
UTTAR PRADESH |
7081014787
bharatmehrotraCR@gmail.com |
| Dr Vijaykumar Bhagwan Barge |
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and General Hospital |
Assistant Professor, Medicine Department, CPR Hospital Dasara chowk, Bhausingji Road, Town hall,Kolhapur,Maharasthtra 416012
Kolhapur
MAHARASHTRA |
7969792775
drvijaybarge12@gmail.com |
| Dr Adesh Kumar |
Uttar Pradesh University of Medical sciences |
A-102, Type-5 Old Campus, UP University of medical Sciences Saifai, Etawah, Uttar Pradesh 206130
Etawah
UTTAR PRADESH |
9045473801
dradeshkumar1974@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee Jeevan Rekha Hospital |
Approved |
| IEC, Citizen Hospital |
Approved |
| IEC,Rajarshee Chhatrapati Shahu Mahraj Govt. Medical College and Chhatrapati Pramila Raje General Hospital. |
Approved |
| Institute Ethics Committee-AIIMS patna |
Approved |
| Institute Ethics Committee-Leelamani Hospital |
Approved |
| Institutional Ethics Committee Uttar Pradesh University of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Airz FB® DPI |
[Glycopyrronium (as Glycopyrrolate
IP) 25mcg + Formoterol Fumarate 12mcg (as Formoterol Fumarate Dihydrate IP) + Budesonide IP 400mcg powder for inhalation DPI for duration of 24 weeks |
| Intervention |
Airz FB® MDI |
[Glycopyrronium (Glycopyrrolate IP) 9mcg + Formoterol (Formoterol (as Formoterol fumarate Dihydrate IP)4.8mcg + Budesonide IP 160 mcg per actuation as inhalation aerosol MDI for duration of 24 weeks |
| Comparator Agent |
None |
None |
|
Inclusion Criteria
Modification(s)
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients more than or equal to 40 years’ age with a documented physician diagnosis of COPD. 2. Symptomatic patients receiving ongoing maintenance therapy (ICS/LABA or LAMA or LABA/LAMA). 3. Patients with exacerbation history in past 1 year. 4. Ability to use MDI/DPI independently and correctly in view of the investigator. 5. 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 |
1. Documented diagnosis of current asthma.
2. Ongoing treatment with Triple therapy i.e. ICS/LABA/LAMA.
3. Subjects with any life threatening condition or requiring hospitalization for management of current condition.
4. 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.
5. 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 GFB MDI/DPI in treatment of patients with COPD in India in terms of -
Number of patients with any drug related treatment emergent adverse events (TEAEs). [Time frame: up to Week 24]
Number of patients with TEAEs [Time Frame: up to Week 24]
Number of patients with serious TEAEs (STEAEs) [Time Frame: up to Week 24] |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of GFB MDI/DPI in treatment of patients with COPD in India in terms of -
Mean change in Trough FEV1 from baseline at week 24.
Mean change in mMRC score from baseline at week 24.
Number of patients with exacerbations (mild/moderate/severe) over 24 weeks.
Proportion of patients requiring hospitalization [Time frame: upto 24 weeks]
Rescue medication use averaged over 24 weeks of treatment.
Compliance with the study medication. [Time frame: At week 24]
Assessment of patients satisfaction with the treatment [Time frame: Upto 24 weeks]
Assessment of physicians satisfaction with the treatment[Time frame: Upto 24 weeks] |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="184"
Sample Size from India="184"
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)
|
23/10/2023 |
| 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
|
Chronic obstructive pulmonary disease (COPD) is a progressive inflammatory lung disease that is characterized by chronic airflow limitation and persistent respiratory symptoms (e.g. dyspnoea, sputum production and cough). Assessment of safety and effectiveness of GFB triple therapy in real world Indian clinical setting would be beneficial for further characterization of its safety and efficacy. Hence, this study has been planned to be conducted in Indian patients to observe its safety and effectiveness for GFB MDI and GFB DPI. The study is a prospective, open label, multicentre, single arm, interventional study to evaluate the safety and effectiveness of GFB MDI/DPI in the management of COPD among Indian patients. Treatment and study duration is of 24 weeks including 4 physical visits and 2 telephonic visits. |