CTRI/2024/01/061230 [Registered on: 08/01/2024] Trial Registered Prospectively
Last Modified On:
02/05/2025
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 trial to evaluate the efficacy and safety of Vilanterol, Glycopyrronium and Fluticasone furoate inhalation as compared to Indacaterol, Glycopyrronium and Mometasone furoate inhalation in patients with persistent asthma
Scientific Title of Study
A prospective, randomized, parallel, active controlled, multicentre, phase III clinical trial to assess the efficacy and safety of Vilanterol, Glycopyrronium and Fluticasone furoate inhalation as compared to Indacaterol, Glycopyrronium and Mometasone furoate inhalation in patients with persistent asthma
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
23-03 Version No. 00 Date: 27/07/2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Clinical Research Room, Ground floor, 5, Anveshan Row House, Opp. Umiya Mata Mandir, Bopal-Ghuma Main Road, Ahmedabad-380058, India Ahmadabad GUJARAT
9825182251
drchintan.cr@gmail.com
Dr Deepak Kumar R
Abhyastha Multispeciality Hospital
Abhyastha Multispeciality Hospital,
347/247, 2nd cross road, Kagdaspura Main Road, C V raman nagar, Bangalore- 560093
Bangalore KARNATAKA
9980700770
cr@abhayahastahospital.com
Dr Ravi Koppula
Government General Hospital
Department of Pulmonology, OPD No: 14, 1st Floor, Government Medical College and Government General Hospital, Srikakulam, Andhra Pradesh-532001, India Srikakulam ANDHRA PRADESH
7995881980
bioexperts21@gmail.com
Dr Sanjay Kumar Verma
GSVM Medical College
Murari Lal Chest hospital, GSVM Medical College, Kanpur-208002, UP, India Kanpur Nagar UTTAR PRADESH
9415075458
vermasanjayk0@gmail.com
Dr Manish Kumar Jain
Maharaja Agrasen Super Specialty Hospital
Maharaja Agrasen Super Specialty Hospital, Central Spine, Agrasen Aspatal Marg, Sector-7, Vidyadhar Nagar, Jaipur-302039, Rajasthan Jaipur RAJASTHAN
9414414834
doctormanishjain2@gmail.com
Dr Jayanta Kumar Panda
SCB Medical College and Hospital
Department of General Medicine,SCB Medical College and Hospital,
Behera Colony, Mangalabag,
Cuttack-753001,
Odisha, India
Cuttack ORISSA
9437028282
drjayantpanda@gmail.com
Dr Diptikant Sahoo
Shanti Memorial Hospital Pvt. Ltd.
Department of Pulmonary Medicine, Patnaik colony, Thoria Sahi, Cuttack-753001, Odisha. India Cuttack ORISSA
91-7325939490
diptikant07@gmail.com
Dr Vaishal Sheth
Sheth Vadilal Sarabhai General Hospital
OPD block, first floor, Trauma Centre, Department of Medicine, Sheth Vadilal Sarabhai General Hospital, Ellis bridge, Ahmedabad – 380006, Gujarat Ahmadabad GUJARAT
Institutional Ethics committee, Abhayastha Hospital, C V Raman Nagar, Bengaluru, Karnataka 560093
Approved
Institutional Ethics Committee, Government Medical College & Government General Hospital, Srikakulam, Andhra Pradesh-532001, India
Approved
Institutional Ethics Committee, S.C.B. Medical College and Hospital, Cuttack-753007, Odisha, India
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: J459||Other and unspecified asthma,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Indacaterol 150 mcg, Glycopyrronium 50 mcg and Mometasone
furoate 160 mcg DPI
one capsule once daily through oral inhalation route for 12 weeks treatment period
Intervention
Vilanterol 12.5 mcg, Glycopyrronium 25
mcg and Fluticasone furoate 100 mcg MDI
The MDI will contain
the test drug, Vilanterol 12.5 mcg, Glycopyrronium 25 mcg and Fluticasone furoate 100 mcg. Patients will be instructed to take 2 actuations once daily through oral inhalation route for 12 weeks treatment period
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1.Patients of either gender between 18-65 years of age (both inclusive)
2. Patients diagnosed with asthma for at least 12 months prior to screening
3. Pre-bronchodilator FEV1 of 40% to 80% of the predicted normal value at screening
4. Patients with bronchodilator reversibility i.e., increase in FEV1 of ≥ 12% and ≥ 200 ml after salbutamol inhalation at screening
5. Patients receiving ICS-LABA combination for asthma for at least 3 months with stable dose of medium or high dose of ICS-LABA combination for ≥ 4 weeks prior to screening
6. Patients who are symptomatic at screening defined as Asthma Control Test (ACT) score ≤ 15
7. Patients with a history of at least one severe asthma exacerbation within past 12 months prior to screening
8. Patients willing to provide written informed consent and comply with the protocol requirements
9 Patients literate enough to fill the diary card
ExclusionCriteria
Details
1. Known hypersensitivity to any β2-agonist, sympathomimetic drug, anti-muscarinic agent or any inhaled, intranasal or systemic corticosteroid
2. History of life-threatening asthma within past 5 years prior to screening
3. Asthma exacerbation requiring systemic corticosteroids or that resulted in hospitalization or emergency room visit within 6 weeks prior to screening
4. Patients treated with a long-acting muscarinic antagonist within 3 months prior to screening
5. Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention
6. Patients diagnosed with COVID-19 within 3 months prior to screening
7. Suspected or confirmed bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear within 4 weeks prior to screening
8. Patients with concurrent respiratory disorder other than asthma such as but not limited to pneumonia, pulmonary tuberculosis, chronic bronchitis, chronic obstructive pulmonary disease, pneumothorax, atelectasis, bronchopulmonary dysplasia, interstitial lung disease, cystic fibrosis
9. Clinical evidence of oropharyngeal candidiasis at screening
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. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effectivecontraception
14. Current smokers or ex-smokers who have stopped smoking within 6 months prior to screening or have a smoking history of at least 10 pack-years
15. Patients with continuing history of alcohol and/or drug abuse
16. Participation in another clinical trial within 3 months prior to screening
17. 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
Centralized
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Change from baseline in trough FEV1 at the end of the study
Baseline to end of study (12 Weeks)
Secondary Outcome
Outcome
TimePoints
Change from baseline in trough FEV1
Baseline to Week 4
Change from baseline in trough FVC
At week 4 and End of study
Change from baseline in post-bronchodilator FEV1 and FVC
At week 4 and End of study
Change from baseline in the ACT score
At week 4, Week 8 and End of study
Proportion of rescue medication free days
During the Study period
Asthma exacerbations reported
During the study period
Global impression of change in the disease condition by the patients
At the end of study period
Safety endpoinrt- Adverse events and serious adverse events reported
During the study period
Overall tolerability evaluation
At the end of study period
Target Sample Size
Total Sample Size="256" Sample Size from India="256" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a prospective, randomized, parallel, active-controlled, multicentre, phase III clinical trial to assess the efficacy and safety of Vilanterol, Glycopyrronium and Fluticasone furoate inhalation as compared to Indacaterol, Glycopyrronium and Mometasone furoate inhalation in patients with persistent asthma. A total of 256 patients with asthma (Test – 128; Reference – 128) would be enrolled into the study, The enrolled patients will be allocated to either of the 2 study groups according to the centralized computer-generated randomization plan in a 1:1 (test: reference) ratio.
Primary objective of the study is to evaluate the efficacy of fixed dose combination (FDC) of Vilanterol 12.5 mcg, Glycopyrronium 25 mcg and Fluticasone furoate 100 mcg metered dose inhaler (MDI) as compared to FDC of Indacaterol 150 mcg, Glycopyrronium 50 mcg and Mometasone furoate 160 mcg dry powder for inhalation (DPI) in patients with persistent asthma , and secondary objective of study is to evaluate the safety of FDC of Vilanterol 12.5 mcg, Glycopyrronium 25 mcg and Fluticasone furoate 100 mcg MDI as compared to FDC of Indacaterol 150 mcg, Glycopyrronium 50 mcg and Mometasone furoate 160 mcg DPI in patients with persistent asthma.