CTRI/2025/10/095635 [Registered on: 06/10/2025] Trial Registered Prospectively
Last Modified On:
19/12/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Randomized, double-blind clinical trial to evaluate the efficacy and safety of FDC of Fluticasone Furoate, Umeclidinium and Vilanterol DPI for treatment of uncontrolled asthma
Scientific Title of Study
A multicenter, randomized, double-blind, parallel group, active-controlled Phase III clinical trial to evaluate the efficacy, safety and tolerability of Fixed-Dose Combination of Fluticasone Furoate, Umeclidinium and Vilanterol Dry Powder for Inhalation in comparison with Fixed-Dose Combination of Indacaterol, Glycopyrronium and Mometasone Furoate Powder for Inhalation in subjects with uncontrolled asthma.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
GPL/CT/2025/002/III, Version 2.0, Dated: 23 May 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Rahul Kodgule
Designation
Sr.GM-Clinical Development Branded Generics
Affiliation
Glenmark Pharmaceuticals Ltd
Address
Glenmark Pharmaceuticals Ltd
Glenmark House, B D Sawant Marg
Chakala, Andheri(East)
District: Mumbai
State: Maharashtra
Mumbai MAHARASHTRA 400099 India
Phone
912240189999
Fax
Email
Rahul.Kodgule@glenmarkpharma.com
Details of Contact Person Public Query
Name
Amol Pendse
Designation
Sr.GM-Clinical Research Operations
Affiliation
Glenmark Research Centre
Address
Glenmark Research Centre,
Plot No. A-607, T.T.C. Industrial Area,
MIDC, Mahape, Navi Mumbai
District: Thane
State: Maharashtra
Department of Medicine, Sir Sayajirao General (S.S.G) Hospital, Medical College Baroda, Anandpura, Jail road (Indira Avenue), Vadodara -390001, Vadodara GUJARAT
9727729105
keyurbrahme@gmail.com
Dr Himanshu Pophale
ACE Hospital and Research Centre
32/2A Gulwani Maharaj Road, Erandwane, Pune-411004, Maharashtra
Pune MAHARASHTRA
9503939461
phophalehimanshu17@gmail.com
DrSaurabh Karmakar
All India Institute of Medical Sciences
OPD Building 3rd Floor, Department of Pulmonary Medicine, Patna, Aurangabad Road Phulwari Sharif Patna, Bihar-801507, India
Patna BIHAR
9839443375
DrSaurabhKarmakar@gmail.com
Dr Ruchi Dua
All India Institute of Medical Sciences, Rishikesh
Department of Pulmonology, Shivaji Nagar, Virbhadra Road, Rishikesh, Uttarakhand- 249 203 Dehradun UTTARANCHAL
7895973469
ruchi.pulm@aiimsrishikesh.edu.in
Dr Sandeep Katiyar
Apollo Spectra Hospital (Apollo Speciality Hospital Pvt.Ltd)
Department of General Medicine, Departmental Research Lab Room No: 7, Ward no. 304, 3rd Floor IPD block, P. B. Road, Vidyanagar, Hubballi-580021 Dharwad KARNATAKA
Ethics Committee of Ishwar Institute of HealthCare
Submittted/Under Review
Ethics Committee relating to Clinical Trial All India Institute Of Medical Sciences Rishikesh
Submittted/Under Review
Ethics Committee S.M.S. Medical College and Attached Hospitals
Approved
Ethics Committee, GSVM Medicial College
Approved
Global Ethics Committee
Approved
IEC IMS and Sum Hospital
Approved
IEC, All India Institute of Medical Sciences, Patna
Submittted/Under Review
IEC, Maharaja Agrasen Hospital
Approved
Institutional Ethics Committee for Human Research (IECHR), Medical College Baroda
Approved
Institutional Ethics Committee Govt Medical College Kozhikode
Submittted/Under Review
Institutional Ethics Committee, Ace Hospital
Approved
Institutional Ethics Committee, MLN Medical college
Approved
Institutional Ethics Committee, SGRR Institute Of Medical Health Science
Approved
Institutional Ethics Committee- Human Research- Lokmanya Tilak Municipal Medical college and General Hopsital
Approved
Institutional Ethics Committee. NKP Salve Institute of Medical Sciences and Research Centre Lata Mangeshkar Hospital,
Approved
KMCRI ETHICS COMMITTEE
Submittted/Under Review
Respira Institutional Ethics Committee, Respira Chest And Critical Care
Approved
Shree Hospital Ethics Committee
Approved
Shri Ambe Institutional Ethics Committee
Approved
Supe Hospital Ethics Committee
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
Intervention
FDC of Fluticasone Furoate 200 µg, Umeclidinium 62.5 µg, Vilanterol 25 µg Dry Powder for Inhalation
Dosage Form: Dry powder for inhalation
Dose: 1 inhalation from the DPI device
Dosage Frequency: 1 inhalation once daily in the morning
Mode of Administration: Oral Inhalation
Comparator Agent
FDC of Indacaterol 150 µg, Glycopyrronium 50 µg and Mometasone Furoate 160 µg Powder for Inhalation
Dosage Form: Powder for inhalation
Dose: 1 inhalation from the DPI device
Dosage Frequency: 1 inhalation once daily in the morning
Mode of Administration: Oral Inhalation
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male and female subjects with age greater than 18 years and less than 65 years (subjects who have celebrated their 18th birthday and have not yet celebrated 65th birthday will be included).
2. Provided written informed consent and are willing to and able to comply with all aspects of the protocol.
ExclusionCriteria
Details
1. Any asthma exacerbation requiring a change in maintenance asthma therapy in the 12 weeks prior to screening visit. Evidence of a moderate-to-severe exacerbation during screening or run-in period, defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
2. Subjects with a diagnosis of chronic obstructive pulmonary disease (COPD).
3. Subjects who are:
• Current smokers (defined as subjects who have used inhaled tobacco products within the 12 months prior to screening visit [i.e., cigarettes, bidi, e-cigarettes/vaping, cigars or pipe tobacco]).
• Former smokers with a smoking history of greater than or equal to 10 pack years (e.g. 20 cigarettes per day for 10 years).
4. Chest x-ray documented pneumonia in the 6 weeks prior to screening visit.
5. Subjects receiving triple therapy with ICS, LABA and long-acting muscarinic antagonist (LAMA) as fixed combination or concomitantly.
6. Subjects with current evidence or history of pneumonia, active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases or abnormalities other than asthma.
7. Subjects with history of risk factor for pneumonia, e.g., immune suppression (e.g., human immunodeficiency virus [HIV], lupus) or other risk factors for pneumonia (e.g., neurological disorders affecting control of the upper airway, such as Parkinson’s disease, Myasthenia gravis).
8. Patients at potentially high risk (e.g. very low body mass index [BMI], severely malnourished, or very low FEV1) will only be included at the discretion of the investigator.
9. Subjects with historical or current evidence or history of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
10. Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
11. Evidence of clinically significant abnormal laboratory tests during screening or run-in which are still abnormal upon repeat analysis (if performed based on investigator’s opinion) and are not believed to be due to disease(s) present. Each investigator will use his/her own discretion in determining the clinical significance of the abnormality.
12. Antimuscarinic effects: Subjects with a medical condition such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy or bladder neck obstruction should only be included if in the opinion of the investigator the benefit outweighs the risk and that the condition would not contraindicate study participation. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
13. Pregnant or breastfeeding.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Change from baseline in trough FEV1
At Week 12
Secondary Outcome
Outcome
TimePoints
Change from baseline in FEV1 area under the curve from time 0 to 2 hours (AUC0-2h)
[Time Point: at Day 1 and week 12]
Change from baseline in peak FEV1
[Time at week 4 and week 12]
Change from baseline in trough FEV1
[Time at week 4 and week 12]
Change from baseline in asthma control questionnaire-7 (ACQ-7) score
[Time at week 4, week 8, and week 12]
Percent rescue medication free days
[Time Point: Over 12-week treatment period]
Target Sample Size
Total Sample Size="278" Sample Size from India="278" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
17/10/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
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
This
is a multicenter, randomized, double-blind, active-controlled clinical trial to
evaluate the efficacy, safety and tolerability of Fixed-Dose Combination of
Fluticasone Furoate, Umeclidinium and Vilanterol Dry Powder for Inhalation in
comparison with Fixed-Dose Combination of Indacaterol, Glycopyrronium and
Mometasone Furoate Powder for Inhalation in subjects with uncontrolled asthma.
Treatments will be
administered over a period of 12 weeks, Efficacy will be evaluated using
spirometry, asthma control assessment and rescue medication use. Spirometry
will be conducted in accordance with the American Thoracic Society
(ATS)/European Respiratory Society (ERS) standards. Asthma control will be
evaluated using Asthma Control Questionnaire (ACQ) and rescue medication use
data will be collected using subject daily diary. The primary outcome measures
consist of change from baseline in in trough FEV1 at week 12.