| CTRI Number |
CTRI/2023/10/058653 [Registered on: 13/10/2023] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A POST MARKETING STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF FLUTICASONE FUROATE/ VILANTEROL (FF/VI) DPI IN THE MANAGEMENT OF ASTHMA PATIENTS (PROMISE OD) |
|
Scientific Title of Study
|
AN OPEN LABEL SINGLE ARM, MULTICENTRIC, PROSPECTIVE, POST MARKETING STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF FLUTICASONE FUROATE/ VILANTEROL (FF/VI) DPI IN THE MANAGEMENT OF ASTHMA PATIENTS (PROMISE OD) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GPL/CT/2022/011/IV/Version 1.0/dated 27-Apr-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumit Bhushan |
| Designation |
Senior Manager- Global Medical Affairs |
| Affiliation |
Glenmark Pharmaceuticals Ltd. |
| Address |
Glenmark Corporate Enclave, BD Sawant Marg, Andheri East,
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400099
India
Mumbai (Suburban)
MAHARASHTRA
400099
India |
| Phone |
8800352225 |
| Fax |
|
| Email |
sumit.bhushan@glenmarkpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Bhushan |
| Designation |
Senior Manager- Global Medical Affairs |
| Affiliation |
Glenmark Pharmaceuticals Ltd. |
| Address |
Glenmark Corporate Enclave, BD Sawant Marg, Andheri East,
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400099
India
Mumbai (Suburban)
MAHARASHTRA
400099
India |
| Phone |
8800352225 |
| Fax |
|
| Email |
sumit.bhushan@glenmarkpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director- Clinical Trial Operations |
| Affiliation |
IR Innovate Research Pvt Ltd |
| Address |
IR Innovate Research Pvt. Ltd
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9971169602 |
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
|
Source of Monetary or Material Support
|
| Glenmark Pharmaceuticals Ltd. Glenmark House, B D Sawant Marg, Andheri East, Mumbai - 400099 |
|
|
Primary Sponsor
|
| Name |
Glenmark Pharmaceuticals Ltd |
| Address |
Glenmark Pharmaceuticals Ltd. Glenmark House, B D Sawant Marg, Andheri East, Mumbai - 400099 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
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 Raghumanda Sunil Kumar |
Government Hospital for Chest and Communicable Diseases (GHCCD) affiliated with KGH |
Government Hospital for Chest and Communicable Diseases (GHCCD), Pedda
Waltair, Visakhapatnam-530017, Andhra Pradesh, India.
Visakhapatnam
ANDHRA PRADESH |
9849126543
chestdrsunil@gmail.com |
| Dr Suresh Raparthy |
St Anns General and Cancer Hospital |
St Anns General and Cancer Hospital, Kazipet, Warangal, Telangana-506004
Warangal
TELANGANA |
9963060098
drsuresh.krewgl@gmail.com |
| Dr Punit Jhawar |
Gillurkar Multispeciality Hospital |
20, Reshimbag, Umred road, Sakkardara, Nagpur-440024, Maharashtra
Nagpur
MAHARASHTRA |
9975937746
dr.punitjhwar@gmail.com |
| Dr Ankit Kumar |
King Georges Medical Hospital |
Department of Respiratory Medicine King Georges Medical University Chowk Lucknow
Lucknow
UTTAR PRADESH |
9305015816
ankyar007@gmail.com |
| Dr Sandeep Kumar Gupta |
MV Hospital and research centre |
MV Hospital and research centre 314 30 mirza mandi chowk lucknow Uttar Pradesh 226003
Lucknow
UTTAR PRADESH |
9336077839
sandeepkumar.gupta@rediffmail.com |
| Dr Satyajeet Sahoo |
Utkal Hospital |
Utkal Hospital Plot no c3 niladri vihar CS Pur Bhubaneswar 751021
Khordha
ORISSA |
7504410809
satyajeetsahoo@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Centurion University of Technology and Management- Independent Ethics Committee(CUTM-IEC) |
Approved |
| Gillurkar Hospital Ethics Committee |
Approved |
| Institutional Ethics Committee for MV Hospital and Research Centre |
Approved |
| Institutional Ethics Committee King Georges Medical University, Lucknow |
Approved |
| Institutional Ethics committee, King George Hospital, Visakhapatnam |
Approved |
| St. Anns Institutional Ethics Committee (SAIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fluticasone furoate/vilanterol (100/25 µg and 200/25 µg ) via dry powder inhaler |
1 capsule to be inhaled daily for 12 Weeks. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged more than or equal to 12 years with a documented diagnosis of asthma
2. Pre-bronchodilator FEV1 of 40-90% predicted normal
3. Symptomatic patients receiving ongoing treatment with either ICS-SABA or ICS LABA or SMART
4. ACQ-5 score more than or equal to 1.5 at baseline.
5. Patient/parent/legal guardian willing to give a written informed consent/parental
consent/assent form.
6. Able to/Willing to strictly adhere to the investigator’s prescription |
|
| ExclusionCriteria |
| Details |
1. History of current hospitalization with life threatening condition or patients with acute
exacerbation of asthma (acute condition).
2. Smoking history of more than 10 pack-years
3. 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.
4. Patients who have participated in any clinical trial within 30 days prior to enrolment and
would not be participating in clinical study during the period of study participation.
5. History of known hypersensitivity to any individual study drug of the study drug
combination or to any of the excipient present in the dosage form. |
|
|
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 patients with asthma in India treated with FF/VI in terms of -
• Number of patients with any drug related treatment emergent adverse events
(TEAEs). [Time frame: up to Week 12]
• Number of patients with TEAEs [Time Frame: up to Week 12]
• Number of patients with serious TEAEs (STEAEs) [Time Frame: up to Week 12]
|
Up to 12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean change in Trough FEV1 from baseline.
Mean change in ACQ-5 score from baseline.
Proportion of patients requiring hospitalization
Rescue medication use averaged over 12weeks of treatment.
Compliance with the study medication.
Assessment of patient satisfaction with the treatment.
Assessment of physician satisfaction with the treatment
|
Up to 12 Weeks |
|
|
Target Sample Size
|
Total Sample Size="178"
Sample Size from India="178"
Final Enrollment numbers achieved (Total)= "178"
Final Enrollment numbers achieved (India)="178" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/10/2023 |
| Date of Study Completion (India) |
02/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
An Open Label Single Arm, Multicentric, Prospective, Post Marketing Study to Evaluate the Safety And Effectiveness of Fluticasone Furoate/ Vilanterol (FF/VI) DPI in the Management of Asthma Patients (Promise OD) Asthma is a chronic inflammatory disorder of the airways associated with hyper responsiveness of airways. Global Burden of Disease (GBD, 1990–2019) estimated the total burden of asthma in India as 34.3 million, accounting for 13.09% of the global burden. There has been a wide range of medication non-adherence rates among patients with asthma, ranging from 30 to 70 percent. Patients with asthma have inadequately controlled disease despite treatment with an inhaled corticosteroid (ICS) and a long-acting Beta 2 agonist (LABA). The addition of a long-acting muscarinic antagonist (LAMA) may provide further benefit, but has traditionally required the use of two separate inhalers. The current Global Initiative for Asthma (GINA 2022) strategy document recommends using ICS/Formoterol combination both as a daily controller and as a rescue medication (MART) as a preferred strategy across. Recommendations by GINA represent a global strategy document but not guideline; therefore, there is a need of treatment strategy based on professional judgment, population characteristics and local healthcare systems. This is an Open Label Single Arm, Multicentric, Prospective, Post Marketing Study to Evaluate the Safety And Effectiveness of Fluticasone Furoate/ Vilanterol (FF/VI) DPI in the Management of Asthma Patients. 178 subjects will be enrolled in this study across 6 centers in India. The treatment duration for each subject will be 12 Weeks. Number of patients with drug related and non-related TEAEs, Number of patients with serious TEAEs up to 12 weeks will be primarily evaluated. Mean change in FEV1 and ACQ-5 score, proportion of patient requiring hospitalization, Rescue medication use, compliance with the study medication, assessment of patient’s satisfaction and physician’s satisfaction with the treatment upto 12 weeks will be evaluated as secondary endpoints.
|