| CTRI Number |
CTRI/2024/06/069178 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Phase IV Study to Assess the Safety and Effectiveness of Fixed Dose Combination (Fluticasone Furoate 100 mcg and Glycopyrronium Bromide 50 mcg and Vilanterol Trifenatate 25 mcg) Inhalation powder for maintenance treatment of Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease |
|
Scientific Title of Study
|
A Multicenter, Prospective, Open Label, Single arm, Phase IV Study to Assess the Safety and Effectiveness of Vilfuro-G Fixed Dose Combination (Fluticasone Furoate 100 mcg and Glycopyrronium Bromide Ph. Eur. eq. to Glycopyrronium 50 mcg and Vilanterol Trifenatate eq. to Vilanterol 25 mcg) Inhalation powder in Capsule for maintenance treatment of Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/23/004, Version-00, Date-19/12/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jamnadas Kushwaha |
| Designation |
Head – Clinical Trial |
| Affiliation |
Raptim Research Pvt. Ltd. |
| Address |
A-226, TTC Industrial Area, Near Mahape Depot, Mahape MIDC, Navi Mumbai, Thane, Maharashtra, 400710, India
Thane
MAHARASHTRA
400710
India |
| Phone |
2227781889 |
| Fax |
2227781889 |
| Email |
jamnadas.kushwaha@raptimresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddhartha Patil |
| Designation |
Project Manager – Clinical Trials |
| Affiliation |
Raptim Research Pvt. Ltd. |
| Address |
A-226, TTC Industrial Area, Near Mahape Depot, Mahape MIDC, Navi Mumbai, Thane, Maharashtra , 400710, India
Thane
MAHARASHTRA
400710
India |
| Phone |
9167079505 |
| Fax |
9167079505 |
| Email |
siddhartha.patil@raptimresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddhartha Patil |
| Designation |
Project Manager – Clinical Trials |
| Affiliation |
Raptim Research Pvt. Ltd. |
| Address |
A-226, TTC Industrial Area, Near Mahape Depot, Mahape MIDC, Navi Mumbai, Thane, Maharashtra , 400710, India
Thane
MAHARASHTRA
400710
India |
| Phone |
9167079505 |
| Fax |
9167079505 |
| Email |
siddhartha.patil@raptimresearch.com |
|
|
Source of Monetary or Material Support
|
| Lupin Ltd., 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz East, Mumbai- 400055, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Lokesh Kumar General Manager |
| Address |
Lupin Ltd., 3rd Floor, Kalpataru Inspire,
Off Western Express Highway, Santacruz East,
Mumbai- 400055, Maharashtra, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Raptim Research Pvt Ltd |
A-242,A-226, TTC Industrial Area, Near Mahape
Depot,Mahape MIDC, Navi Mumbai – 400710,Maharashtra, India |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashish Kumar Jaiswal |
Ajanta Hospital and IVF Center |
Hall D, Ground Floor, 765, ABC Complex, Kanpur Road, Alambagh, Lucknow 226005
Lucknow
UTTAR PRADESH |
9453959152
drashishtbc@gmail.com |
| Dr Jayesh Ambaliya |
Divine Multispecialty Hospital |
Department of General Medicine
2nd and 3rd floor, Shikshapatri, Sky Court, Near Swagat Flamingo, Sargasan, 382421
Gandhinagar
GUJARAT |
9998310174
jayeshambaliya05.ja@gmail.com |
| Dr Vaghani Mahesh |
Global Hospital |
OPD 1, 4th floor, Besides Navjivan, Sarthana, Jakatnaka, Surat 395006
Surat
GUJARAT |
9825433984
9825433984
maheshavaghani@gmail.com |
| Dr Vikas Deep Mishra |
Janta Hospital and Maternity Centre |
Ground Floor, OPD No. 02. Janta Hospital and Maternity Center, Near Water Head Tank, Amara-Akhari Bypass, Chunar Road, India, 221011
Varanasi
UTTAR PRADESH |
9532876406
vikasdmishra@gmail.com |
| Dr Namrata Modi |
Life Care Hospital |
OPD No. 4, 1st Floor, Life Care Hospital, Lekha Nagar, New Nashik, Mumbai, Agra Highway, 422009
Nashik
MAHARASHTRA |
7045103821
namratamodi11@gmail.com |
| Dr Anand Yannawar |
Sangvi Multi Specialty Hospital |
OPD no. 01, Ground Floor
Serve no. 71/1/2/189,
Krushna Chowk,
New Sangvi, Pune,
Maharashtra 411027
Pune
MAHARASHTRA |
9860995923
9860995923
dranand.sangvihospital@gmail.com |
| Dr Deepak Varade |
Shree Ashirwad Hospital |
Room No. 1, 2nd Floor C-3 Shree Complex, Opposite to Mahavir Nagar, Manpada Road, Dombivli-East, 422009
Mumbai
MAHARASHTRA |
9870409142
deepak.varade@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Altezza Institutional Ethics Committee |
Approved |
| Divine Ethics Committee |
Approved |
| Global Ethics Committee |
Approved |
| IEC Ajanta Hospital and IVF Centre |
Approved |
| IEC-Sangvi Multispecialty Hospital |
Approved |
| Janta Hospital Ethics Committee |
Approved |
| Muktai Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fluticasone Furoate 100 mcg +Glycopyrronium Bromide Ph. Eur. eq. to Glycopyrronium 50 mcg + Vilanterol Trifenatate eq. to Vilanterol 25 mcg |
100 mcg + 50 mcg + 25 mcg,
Once Daily,
Dry Powder Inhalation,
Route of administration: Inhalation
Total duration of intervention : once daily for 12 weeks (84 days)
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Males and females aged 18 years and above.
2. Diagnosed with moderate to severe COPD as per the Global Initiative for Obstructive Lung Disease (GOLD) 2023 guidelines classification.
3. COPD Assessment Test (CAT) score ≥ 10 even after receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) for at least 4-6 weeks at the time of screening.
4. Willing to take the medications as directed.
5. Willing to comply with the protocol requirements.
6. Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures.
7. Post-menopausal female patients, or female of child bearing age must agree to use highly effective contraceptive measures with her partner during the study and for 90 days following their last dose.
|
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity to Fluticasone, Glycopyrronium, Vilanterol, other beta-2 agonists, other anti-muscarinic agents, other corticosteroids or excipients of formulation.
2. Known α1-antitrypsin deficiency.
3. Known history of HIV or HBV or HCV infection.
4. COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period.
5. Hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period.
6. Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period.
7. Known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention.
8. Clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy.
9. Known history of hepatic dysfunction.
10. With continuing history of alcohol and/or drug abuse.
11. Not willing to give written informed consent.
12. Any other condition/ uncontrolled co-morbid conditions that, in the opinion of the investigator, does not justify the inclusion of the patient in the study.
13. Pregnant women.
14. Lactating females.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patients with Adverse Events (AEs)
Incidence rate of AEs (Serious/non-serious, Expected/Non- expected, Related/ Non-related)
Safety of patient will be monitored throughout the study
|
Entire duration of Study and at Week 6 and a Week 12 (EOS) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean change in COPD Assessment Test (CAT) score at week 12 from baseline.
Proportion of patients with improvement in modified Medical Research Council (mMRC) score at end of week 12.
CAT comprises 8 questions; each is presented as a 6-point (0-5) differential scale, providing a total score out of 40. Scores of 0-10, 11-20, 21-30, 31-40 represent mild, moderate, severe or very severe clinical impact, respectively.
The mMRC dyspnea score is a 5-point (0-4) scale based on the severity of dyspnea experienced by patient as shown below:
|
At Week 6 & a Week 12 (EOS) |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| Date of Study Completion (India) |
04/03/2025 |
| 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)
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
|
COPD is a common preventable, and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation due to abnormalities in the airway and (or) alveolar abnormalities. It is the leading cause of disability among chronic respiratory diseases and was the second leading contributor of Disability Adjusted Life Years (DALY) in 2016. In 2016, nearly 32% of global DALYs due to COPD occurred in India and COPD is responsible for 75.6% of total DALYs among chronic respiratory disease in India. The Purpose of the Study is To evaluate the safety & Effectiveness of FDC for maintenance treatment of Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) |