| CTRI Number |
CTRI/2025/04/085135 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the safety and effectiveness of Vilanterol and Fluticasone Furoate powder for inhalation in patients with asthma.
|
|
Scientific Title of Study
|
A prospective, open label, single-arm, multicentre, active post-marketing surveillance study to assess safety and effectiveness of Vilanterol 25 mcg and Fluticasone Furoate 200 mcg powder for inhalation in patients with asthma.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 23-08, Version No.: 00 and Dated Nov 28, 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deven V Parmar |
| Designation |
Chief Medical Officer and Head Clinical R & D |
| Affiliation |
Zydus Healthcare Limited |
| Address |
Zydus Research Centre, Sarkhej - Bavla N.H. No.8A, Moraiya.
Ahmadabad
GUJARAT
382213
India |
| Phone |
2717665555 |
| Fax |
|
| Email |
dparmar@zydustherapeutics.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kevinkumar Kansagra |
| Designation |
Senior General Manager and Clinical R & D |
| Affiliation |
Zydus Healthcare Limited |
| Address |
Zydus Research Centre, Sarkhej - Bavla N.H. No.8A, Moraiya.
Ahmadabad
GUJARAT
382213
India |
| Phone |
2717665555 |
| Fax |
|
| Email |
kevinkumarkansagra@zyduslife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hardik Pathak |
| Designation |
General Manager and Clinical R & D |
| Affiliation |
Zydus Healthcare Limited |
| Address |
Zydus Research Centre, Sarkhej - Bavla N.H. No.8A, Moraiya.
Ahmadabad
GUJARAT
382213
India |
| Phone |
2717665555 |
| Fax |
|
| Email |
Hardik.L.Pathak@zyduslife.com |
|
|
Source of Monetary or Material Support
|
| Zydus Lifesciences Limited, Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej-Gandhinagar Highway, Ahmedabad-382481, Gujarat. |
|
|
Primary Sponsor
|
| Name |
Zydus Healthcare Limited |
| Address |
Zydus Corporate Park,
Scheme No. 63, Survey No. 536,
Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej-Gandhinagar Highway,
Ahmedabad-382481, Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chintan B Patel |
Aatman Hospital |
5, Anveshan Row House, Opp. Umiya Mata Mandir,
Bopal-Ghuma Main Road, Bopal, Ahmedabad-380058
Ahmadabad
GUJARAT |
9825182251
cr.aatman@gmail.com |
| Dr Ravi Koppula |
Government Medical College & Government General Hospital |
Srikakulam, Andhra Pradesh-532001
Srikakulam
ANDHRA PRADESH |
7995881980
bioexperts21@gmail.com |
| Dr Deep Rajendrabhai Kothari |
Hope Well Medical Hospital |
Research Room, Block G, 1st Floor, 101, 102, Sumel-8, Nr. Ajit Mill Char Rasta, Rakhiyal, Ahmedabad-380023.
Ahmadabad
GUJARAT |
9537483669
kotharideep316@gmail.com |
| Dr Manish Kumar Jain |
Maharaja Agrasen Superspeciality Hospital |
Central Spine, Agrasen Aspatal Marg, Sector-7, Vidyadhar Nagar, Jaipur-302039
Jaipur
RAJASTHAN |
9414414834
doctormanishjain2@gmail.com |
| Dr Diptikant Sahoo |
Shanti Memorial Hospital |
Thoria Sahi, Patnaik Colony,
Cuttack - 753001
Cuttack
ORISSA |
7325939490
diptikant07@gmail.com |
| Dr Vaishal Sheth |
Sheth Vadilal Sarabhai General Hospital & Sheth Chinai Maternity Hospital |
Ellis bridge, Ahmedabad-380006
Ahmadabad
GUJARAT |
9925965133
drvsheth@gmaiI.com |
| Dr Amit Asati |
SMC Heart Institute and IVF Research Centre |
Research Room, Infront of BSNL Office, Vidhan Sabha Road, Khamardih, Raipur-492007.
Raipur
CHHATTISGARH |
9630283888
dr.amitasati@gmail.com |
| Dr Konatham Rambabu |
Visakha Institute of Medical Sciences |
Department of General Medicine, NH-16, Hanumanthavaka Junction, Visakhapatnam-530040.
Visakhapatnam
ANDHRA PRADESH |
9177747328
drkrambaburesearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maharaja Agrasen Superspeciality Hospital |
Approved |
| Institutional Ethics Committee, Visakha Institute of Medical Sciences (VIMS) |
Approved |
| Sangini Hospital Ethics Committee C/o Sangini Hospital - Hope Well Medical Hospital |
Approved |
| SMC Heart Institute Institutional Ethics Committee, SMC Heart Institute and IVF Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J45||Asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Vilanterol 25 mcg and Fluticasone Furoate 200 mcg powder |
1 capsule to be inhaled daily for 12 Weeks. This capsule to be taken through Respihaler device. It should be administered at the same time of the day, each day. If a dose is missed, the next dose should be taken at the usual time the next day. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex between 12 to 75 years of age (both inclusive) with a documented diagnosis of asthma
2. Pre-bronchodilator FEV1 of 40 percentage to 80 percentage of the predicted normal value at visit 1
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 or parent or legal guardian willing to give a written informed consent or parental consent or assent form.
6. Able to or Willing to strictly adhere to the investigators 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 other clinical trial within 30 days prior to enrolment and would not be participating in any other 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 |
1. Number of patients with any drug related treatment emergent adverse events (TEAEs) in time-frame up to 12 weeks
2. Number of patients with all TEAEs in time-frame up to 12 weeks
3. Number of patients with serious TEAEs in time-frame up to 12 weeks |
Up to 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in trough FEV1 from baseline to 12 weeks |
Baseline (Visit 1 / Day 0)
&
End of study (Visit 4 / Week 12) |
| Mean change in ACQ-5 score from baseline to 4 week, 8 week and 12 weeks |
Baseline (Visit 1 / Day 0),
Visit 2 (Week 4),
Visit 3 (Week 8)
&
End of study (Visit 4 / Week 12) |
| Mean change in trough FVC from baseline to 12 weeks |
At baseline (Visit 1 / Day 0)
&
At End of study (Visit 4 / Week 12) |
| Proportion of patients requiring hospitalization |
Up to 12 weeks |
| Rescue medication use averaged over 12 weeks of treatment. |
Up to 12 weeks |
Compliance with the study medication.
|
Visit 2 (Week 4),
Visit 3 (Week 8)
&
End of study (Visit 4 / Week 12) |
Assessment of patient satisfaction with the treatment.
|
At End of study (Visit 4 / Week 12) |
| Assessment of physician satisfaction with the treatment |
At End of study (Visit 4 / Week 12) |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
Final Enrollment numbers achieved (Total)= "190"
Final Enrollment numbers achieved (India)="190" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/05/2025 |
| Date of Study Completion (India) |
08/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
This is an prospective, open label, single-arm, multicentre, active post-marketing surveillance study to assess safety and effectiveness of Vilanterol 25 mcg and Fluticasone Furoate 200 mcg powder for inhalation in patients with asthma.
The patients with documented diagnosis of asthma will be directly enrolled (visit 1) in this active PMS study. The eligible patients will then be followed up on an outpatient basis with scheduled visits at week 4 (visit 2), week 8 (visit 3) and week 12 (visit 4). All the enrolled patients will be instructed to take the study medication for a treatment period of 12 weeks.
All patients will be advised to take 1 capsule to be inhaled daily for 12 Weeks. It should be taken through Respihaler device. It should be administered at the same time of the day, each day. If a dose is missed, the next dose should be taken at the usual time the next day. After inhalation, patients should rinse their mouth with water without swallowing.
Use of Salbutamol MDI (100 mcg/puff) would be permitted only as a rescue medication. The patients will be instructed to take 1-2 puffs of salbutamol MDI in the event of acute breathlessness, with a maximum of 8 puffs in a day. |