| CTRI Number |
CTRI/2023/03/050717 [Registered on: 15/03/2023] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to assess the efficacy and safety of Glycopyrrolate, Formoterol Fumarate and Budesonide Inhalation in patients with Chronic Obstructive Pulmonary Disease |
|
Scientific Title of Study
|
A prospective, single-arm, multicentre, phase IV clinical trial to assess the efficacy and safety of Glycopyrrolate, Formoterol Fumarate and Budesonide Inhalation 9 mcg, 4.8 mcg and 160 mcg in patients with Chronic Obstructive Pulmonary Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project No. 22-05 Version No. 00 Date: 03/05/2022 |
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, Ahmedabad
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, Ahmedabad
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, Ahmedabad
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 |
|
|
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
Modification(s)
|
| Name |
Address |
| Clinical Research Network India CRO |
B-806-807, 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 = 4 |
| 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 Ahmedabad - 380058, India
Ahmadabad
GUJARAT |
9825182251
cr.aatman@gmail.com |
| Dr Ravi Koppula |
Govt. Medical College Govt.General Hospital, Srikakulam |
Govt. Medical College Govt.General Hospital,(Old RIMSCGGH) Srikakulam, Andhra Pradesh
Srikakulam
ANDHRA PRADESH |
799581980
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 Bharat Mehrotra |
New Leelamani Hospital |
14/116, C-1, Parade Chauraha, Civil Lines, Kanpur -208001
Kanpur Dehat
UTTAR PRADESH |
7880668537
asthasinghcms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee Jeevan Rekha Hospital |
Approved |
| Institutional Ethics Committee Leelamani Hospital Kanpur |
Approved |
| Institutional Ethics Committee, Govt. Medical College Govt.General Hospital, Srikakulam |
Approved |
| Institutional Ethics Committee, Aatman Hospital |
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 |
Glycopyrrolate, Formoterol Fumarate and Budesonide Inhalation
9 mcg, 4.8 mcg and 160 mcg |
All patients will be asked to take two inhalations of
Glycopyrrolate, Formoterol Fumarate and Budesonide Inhalation
9 mcg, 4.8 mcg and 160 mcg twice daily (two inhalations in the morning and two inhalations in the evening) for a duration of 12 weeks |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex 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:
o Post-bronchodilator FEV1/FVC ratio < 0.7;
o 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. Written informed consent from the patient
6. Patients literate enough to fill the diary card and willing to comply with the protocol requirements
|
|
| 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 α1 antitrypsin deficiency
3. Patients diagnosed with COVID-19 in last 3 months
4. COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period
5. Patients 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. Patients who required long-term oxygen therapy (≥12hours/day) within 4 weeks prior to the screening or during the screening period
8. Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention
9. Patients with known hypersensitivity to formoterol, glycopyrronium, salbutamol, other beta-2 agonists or other anti-muscarinic agents
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 with continuing history of alcohol and/or drug abuse
13. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
14. Participation in another clinical trial in the past 3 months
15. Any other reason for which the investigator feels that the patient should not participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in trough FEV1 at week 4 and week 12 as compared to baseline |
week 4 and 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
â— Change in CATTM score at week 4, 8 and 12 as compared to baseline
â— Change in trough FVC at week 4 and week 12 as compared to baseline
â— Change in post-bronchodilator FEV1 and FVC at week 4 and week 12 as
compared to baseline
â— Responder rate at week 4 and week 12
â— Rescue bronchodilator use during treatment period
â— Proportion of patients with COPD exacerbations during the study
Safety endpoints will be:
â— Adverse events reported during the study
â—Serious adverse events reported during the study
|
week 4, 8 and 12. |
|
|
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)
Modification(s)
|
31/03/2023 |
| Date of Study Completion (India) |
14/08/2023 |
| 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 Yet Recruiting |
| 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
|
A prospective, single-arm, multicentre, phase IV clinical trial to assess the efficacy and safety of Glycopyrrolate, Formoterol Fumarate and Budesonide Inhalation 9 mcg, 4.8 mcg and 160 mcg in patients with Chronic Obstructive Pulmonary Disease. With the primary objective of this clinical study is to evaluate the efficacy and safety of fixed dose combination of Glycopyrronium, Formoterol Fumarate and Budesonide Inhalation 9 mcg, 4.8 mcg and 160 mcg in patients with Chronic Obstructive Pulmonary Disease.A total of 200 patients of COPD at geographically distributed centres in India will be enrolled in this clinical trial to evaluate the efficacy and safety of fixed dose combination of Glycopyrronium, Formoterol Fumarate and Budesonide Inhalation 9 mcg, 4.8 mcg and 160 mcg.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 (visit 1) within 3 days prior to their enrolment. The eligible patients will then be enrolled at baseline visit (visit 2, day 0). After enrolment, 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 single arm study and all the enrolled patients will be given the fixed dose combination of Glycopyrronium, Formoterol Fumarate and Budesonide Inhalation 9 mcg, 4.8 mcg and 160 mcg to be taken in a dose of two inhalations twice daily (two inhalations in the morning and two inhalations in the evening) by the oral inhalation route. |