| CTRI Number |
CTRI/2023/02/049362 [Registered on: 01/02/2023] Trial Registered Prospectively |
| Last Modified On: |
07/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to assess the efficacy and
safety of Vilanterol, Glycopyrronium and
Fluticasone furoate Inhalation in patients with Chronic Obstructive Pulmonary Disease |
|
Scientific Title of Study
|
A prospective, randomized, double-blind,
parallel, active-controlled, multicentre, phase
III clinical trial to assess the efficacy and
safety of Vilanterol, Glycopyrronium and
Fluticasone furoate Inhalation as compared to
Glycopyrrolate, Formoterol Fumarate and
Budesonide Inhalation in patients with Chronic Obstructive Pulmonary Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project No. 22-10 Version No. 00 Date: 13/10/2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head-Regulatory Affairs |
| Affiliation |
Zydus Healthcare Limited |
| Address |
Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj
(Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej Gandhinagar
Highway,Ahmadabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
07948041430 |
| Fax |
|
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Deputy General Manager, Clinical Research and Regulatory Affairs |
| Affiliation |
Zydus Healthcare Limited |
| Address |
Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj
(Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej Gandhinagar
Highway,Ah
Ahmadabad
GUJARAT
382481
India |
| Phone |
07948041430 |
| Fax |
|
| Email |
Jayeshsanmukhani@zyduslife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Deputy General Manager, Clinical Research and Regulatory Affairs |
| Affiliation |
Zydus Healthcare Limited |
| Address |
Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj
(Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej Gandhinagar
Highway,Ah
Ahmadabad
GUJARAT
382481
India |
| Phone |
07948041430 |
| Fax |
|
| Email |
Jayeshsanmukhani@zyduslife.com |
|
|
Source of Monetary or Material Support
|
| Zydus Healthcare Limited,
Zydus Corporate Park,
Scheme No. 63, Survey No. 536,
Khoraj (Gandhinagar), Nr. Vaishnodevi Circle,
Sarkhej-Gandhinagar Highway,
Ahmedabad-382481, Gujarat, India.
Phone No.: 079-48040000
|
|
|
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.
Phone No.: 079-48040000
Fax No.: 079-48041500
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Clinical Research Network India CRO |
B-821, 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
|
| 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 Ghuma
Ahmadabad
GUJARAT |
9825182251
cr.aatman@gmail.com |
| Dr Saurabh Karmakar |
AIIMS, Patna |
All India lnstitute ofMedical Sciences,Phulwari Sharif Patna 801507.
Patna
BIHAR |
7783892746
drkarmakar01@gmail.com |
| Dr Anand Patel |
GMRS Medical College and General Hospital |
GMRS Medical College and General Hospital Gotri Road Old TB Campus Vadodara 390021
Vadodara
GUJARAT |
9879771079
dranandkpatel@gmail.com |
| Dr Ravi Koppula |
Govt. Medical College Govt.General Hospital Balaga Srikakulam |
Govt. Medical College Govt.General Hospital Balaga Srikakulam
Srikakulam
ANDHRA PRADESH |
7995881980
bioexperts21@gmail.com |
| Dr Amit S Bhate |
Jeevan Rekha Hospital |
Dr. B.R Ambedkar
Road, Belagavi-590002
Belgaum
KARNATAKA |
9667177125
dr.amitsureshbhate@gmail.com |
| Dr Sarat Kumar Behera |
Kanungo Institute of Diabetes Specialties |
Kanungo Institute of Diabetes Specialties Bhubaneswar Khordha Orissa-75101
Baleshwar
ORISSA |
9438554039
drsarat2010@rediffmail.com |
| Dr Bharat Mehrotra |
New Leelamani Hospital |
14/116,C-1 pared chauraha civil lines, Kanpur, up 208001
Kanpur Dehat
UTTAR PRADESH |
7081014787
drbharatmehrotra126@gmail.com |
| Dr Vijay Kumar Barge |
Rajarshee Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital |
Rajarshee Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital Dasara Chowk Bhausinghaji Road Town hall Kolhapur Maharashtra- 416012
Kolhapur
MAHARASHTRA |
7969792775
drvijaybarge12@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee Jeevan Rekha Hospital Dr. B R Ambedkar Road Belagavi |
Approved |
| Institutional Ethics Committee Aatman Hospital 5, Anveshan Row House Opp. Umiya , Mata Mandir, Bopal-Ghuma Main Road, Bopal Ahmedabad |
Approved |
| Institutional Ethics Committee All India Institute of Medical Science Patna Bihar |
Approved |
| Institutional Ethics Committee Government Medical College & Government General Hospital Srikakulam |
Approved |
| Institutional Ethics Committee New Leelamani Hospital 14/116, C-1, Parade Chauraha Civils Lines, Kanpur |
Approved |
| Institutional Human Ethics Committee GMERS Medical College and Hospital Vadodara |
Approved |
| KIDS Ethics Committee Kanungo Institute of Diabetes Specialities 1120 Dumduma Bhubaneswar Khordha Orissa |
Approved |
| Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College & Chhatrapati Pramila Raje Hospital ,Kolhapur, 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 |
| Comparator Agent |
Glycopyrrolate, Formoterol
Fumarate and Budesonide Inhalation 9 mcg,
4.8 mcg and 160 mcg |
Patients will dispensed 2 MDIs each; one for the morning dose
and another for the evening dose during visit 2 and visit 4. Both the MDIs will contain
the reference drug, Glycopyrrolate, Formoterol Fumarate and Budesonide Inhalation 9 mcg, 4.8 mcg and 160 mcg. Patients will be instructed to administer 2 actuations at a time through oral inhalation route from the dispensed MDIs at regular interval for a treatment period of 12 weeks |
| Intervention |
Vilanterol, Glycopyrronium and
Fluticasone furoate Inhalation 12.5 mcg, 25 mcg and 50 mcg
|
Patients will dispensed 2 MDIs each; one for the morning dose and another for the evening dose during visit 2 and visit 4. The MDI for morning dose will contain the test drug, Vilanterol, Glycopyrronium and Fluticasone furoate Inhalation
12.5 mcg, 25 mcg and 50 mcg while the MDI for evening dose will contain placebo.
Patients will be instructed to administer 2 actuations at a time through oral inhalation
route from the dispensed MDIs at regular interval for a treatment period of 12 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender between 40-65 years of age (both inclusive)
2. Patients who are current/ex-smokers
3. Patients diagnosed with moderate to severe COPD as per the GOLD guidelines classification at screening visit:
a. Post-bronchodilator FEV1/FVC ratio < 0.7;
b. Post-bronchodilator FEV1, ≥ 30% to < 80% predicted
4. COPD Assessment Test (CATTM) score ≥ 10 even after receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) for at least 4 weeks at the time of screening
5. Patients willing to provide written informed consent and comply with the protocol requirements
6. Patients literate enough to fill the diary card |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc.
2. Patients with known hypersensitivity to formoterol, vilanterol, glycopyrronium,
fluticasone, budesonide, salbutamol, other beta-2 agonists or other antimuscarinic agents
3. Patients diagnosed with COVID-19 within 3 months prior to screening
4. Patients with known α1 antitrypsin deficiency
5. COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period
6. Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period
7. Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period
8. Patients who required long-term oxygen therapy (≥12 hours/day) within 4 weeks prior to the screening or during the screening period
9. Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention
10. Patients with clinically significant uncontrolled systemic diseases such as
cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy
11. Patients with hepatic dysfunction (serum transaminases ≥ 3 x Upper Normal Limit) or renal dysfunction (serum creatinine ≥ 2.5 mg/dl) at screening
12. Patients who have used prohibited medications
13. Patients with continuing history of alcohol and/or drug abuse
14. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
15. Participation in another clinical trial in the past 3 months
16. Any other reason for which the investigator feels that the patient should not participate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change from baseline in trough FEV1 at the end of the study in the two groups
|
12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from baseline in trough FEV1 at week 4 in the two groups
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="220" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
11/02/2023 |
| Date of Study Completion (India) |
14/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This will be a prospective, randomized, double-blind, parallel, active-controlled, multicenter, non-inferiority study planned to evaluate the efficacy and safety of the test drug, Vilanterol, Glycopyrronium and Fluticasone furoate Inhalation 12.5 mcg, 25 mcg and 50 mcg as compared to the reference drug, Glycopyrrolate, Formoterol Fumarate and Budesonide Inhalation 9 mcg, 4.8 mcg and 160 mcg in the patients with moderate to severe COPD. The test drug is indicated for once daily dosing while the reference drug is indicated for twice daily dosing. Due to this difference in dosing of the test and the reference drugs, a MDI containing placebo will be used for the patients enrolled in the test group to maintain double-blinding. All the MDIs containing the test drug, the reference drug or the placebo will have identical physical characteristics and will be indistinguishable from each other. Randomization will prevent the selection / treatment allocation bias and double-blinding will prevent the bias in the assessment of treatment effects. Randomized patients will be enrolled in either of the 2 study groups as per their randomization number and will be followed up in a parallel manner till the completion of study. Patients with moderate to severe COPD receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) and satisfying the below Inclusion & Exclusion will be enrolled in this study. A total of 220 patients at multiple centres geographically distributed over the country will be enrolled in this clinical trial. Enrollment at various clinical trial sites will be competitive. In this study, the patients with moderate to severe COPD receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) will be screened (visit1) within 3 days prior to their enrolment. The eligible patients will then be enrolled and randomized to either of the 2 study groups as per their randomization number on baseline visit (visit 2, day 0). After randomization, patients will then be followed up on an outpatient basis with scheduled visits at week 4 (visit 3), week 8 (visit 4) and week 12 (visit 5). This will be a parallel group study and all the enrolled patients will be instructed to take the allocated study medications for a treatment period of 12 weeks. |