| CTRI Number |
CTRI/2024/06/069544 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| 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 Safety and Efficacy of Vilanterol 40 mcg and Glycopyrronium 63 mcg as maintenance treatment in moderate to severe COPD patients. |
|
Scientific Title of Study
|
A Multicenter, Prospective, Open Label, Single arm, Phase IV Study to Assess the Safety and Effectiveness of Fixed Dose Combination of Vilanterol Trifenatate eq. to 25 mcg Vilanterol 40 mcg and Glycopyrronium Bromide eq. to 50 mcg Glycopyrronium 63 mcg Powder for Inhalation in Capsule indicated as maintenance treatment for Patients with Chronic Obstructive Pulmonary Disease. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/23/003 Version 00, Date: 18/01/24 |
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 |
| Phone |
2227781889 |
| Fax |
2227781889 |
| Email |
jamnadas.kushwaha@raptimresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddhartha Patil |
| Designation |
Project Manager-Clinical Trial |
| Affiliation |
Raptim Research Pvt. Ltd. |
| Address |
A-226 TTC Industrial area, Near Mahape depot, Mahape MIDC, Navi mumbai
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 Trial |
| Affiliation |
Raptim Research Pvt. Ltd. |
| Address |
A-226 TTC Industrial area, Near Mahape depot, Mahape MIDC, Navi mumbai
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 |
Lupin Ltd |
| Address |
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 = 6 |
| 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, Ajanta Research Centre, 765, ABC Complex, Kanpur Road, Alambagh, Lucknow 226005
Lucknow
UTTAR PRADESH |
9453959152
drashishtbc@gmail.com |
| Dr Jayesh Ambaliya |
Divine Multispecialty Hospital |
2nd and 3rd floor, Dept of General Medicine
Divine Multispecialty Hospital,Shikshapatri Sky Court, Near Swagat Flamingo, Sargasan, 382421
Gandhinagar
GUJARAT |
7861812966
jayeshambaliya05.ja@gmail.com |
| Dr Vaghani Mahesh |
Global Hospital |
OPD 1, 4th floor, Besides Navjivan, Sarthana, Jakatnaka, 395006
Surat
GUJARAT |
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, 221011 India
Varanasi
UTTAR PRADESH |
9532876406
vikasdmishra@gmail.com |
| Dr Anand Yannawar |
Sangvi Multi Specialty Hospital |
OPD no. 1, Ground Floor, Krushna Chowk, New Sangvi, 411027
Pune
MAHARASHTRA |
9860995923
dranand.sangvihospital@gmail.com |
| Dr Varade Deepak Bhanudas |
Shree Ashirwad Hospital |
Room no. 1, second Floor, C 3 Shree Complex, Opposite to Mahavir Nagar, Manpada Road, Dombivli-East, 421201
Mumbai
MAHARASHTRA |
9870409142
deepak.varade@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ajanta Hospital & IVF Centre |
Approved |
| Altezza Institutional Ethics Committee |
Approved |
| Divine Ethics Committee |
Approved |
| Global Ethics Committee |
Approved |
| IEC-Sangvi Multispecialty Hospital |
Approved |
| Janta Hospital 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 |
| Comparator Agent |
NA |
NA |
| Intervention |
Vilanterol Trifenatate eq. to 25 mcg Vilanterol 40 mcg + Glycopyrronium Bromide eq. to 50 mcg Glycopyrronium 63 mcg |
25 mcg and 50 mcg,
Once Daily, Dry Powder
Inhalation,
Route of administration: Inhalation
Total duration of intervention : once daily for 12 weeks (84 days) |
|
|
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.mMRC ≥2 even after receiving monotherapy (LABA or LAMA) or dual therapy (LABA + ICS) for at least 4-6 weeks at the time of screening.
3.COPD Assessment Test (CAT) score ≥ 10 even after receiving monotherapy (LABA or LAMA), dual therapy (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 Glycopyrronium, Vilanterol, other beta-2 agonists, other anti-muscarinic agents, 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
|
6 weeks |
|
|
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.
|
12 week |
|
|
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)
|
07/07/2024 |
| Date of Study Completion (India) |
17/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="8" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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 of FDC of Vilanterol Trifenatate eq. to 25 mcg Vilanterol 40 mcg +
Glycopyrronium Bromide eq. to 50 mcg Glycopyrronium 63 mcg indicated as
maintenance treatment of Patients with Chronic Obstructive Pulmonary Disease
(COPD) |