CTRI/2025/02/080495 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On:
05/07/2025
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 phase III clinical trial to assess the efficacy and safety of Vilanterol, Umeclidinium and Fluticasone furoate inhalation as compared to Vilanterol and Fluticasone furoate inhalation in patients with uncontrolled asthma
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, Umeclidinium and Fluticasone furoate inhalation as compared to Vilanterol and Fluticasone furoate inhalation in patients with uncontrolled asthma.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
24-08,Version 00,25.06.2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Deven V Parmar
Designation
Chief Medical Officer & Head
Affiliation
Zydus Research Centre
Address
Sarkhej- Bavla N.H. No.8A, Moraiya,
Ahmadabad GUJARAT 382212 India
Phone
02717665555
Fax
Email
dparmar@zydustherapeutics.com
Details of Contact Person Scientific Query
Name
Dr Pavankumar Daultani
Designation
General Manager
Affiliation
Zydus Research Centre
Address
Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village: Moraiya, Ahmedabad-382213
Ahmadabad GUJARAT 382481 India
Phone
02717665555
Fax
Email
pavankumar.daultani@zyduslife.com
Details of Contact Person Public Query
Name
Dr Pavankumar Daultani
Designation
General Manager
Affiliation
Zydus Research Centre
Address
Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village: Moraiya, Ahmedabad-382213
Ahmadabad GUJARAT 382481 India
Phone
02717665555
Fax
Email
pavankumar.daultani@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..
"Department of Respiratory Medicine,
2nd Floor GMERS Medical College and General Hospital Gotri,
Gotri Road, Old TB Campus, Vadodara -390021
Gujarat – 390021
India."
Vadodara GUJARAT
9879771079
dranandkpatel@gmail.com
Dr Rahul Jalan
Harshil Medical Nursing Home
"19, Asha Society, Near Verai Mata Temple,
near Isnapur bus stop, Isanpur-bhairavnath road.
Isnapur, Ahmedabad. Gujarat 382443"
Ahmadabad GUJARAT
7507004870
drrahulkjalan@gmail.com
Dr Sahoo Srinibas
Hi-Tech Medical College & Hospital
Health park, Pandara, Bhubaneshwar, Odisha- 751025 Khordha ORISSA
"Medical College and Hospital Kolkata,
88, College Street,
Kolkata-700073, West Bengal, India"
Kolkata WEST BENGAL
8777079509
rbrbhattacharya@gmail.com
Dr Amitabh Das Shukla
MLN Medical College
"Institutional Ethics Committee, MLN Medical College
MLN Medical College Motilal Nehru Medical College,
George Town, Prayagraj,
Allahabad, Uttar Pradesh - 211002, India"
Allahabad UTTAR PRADESH
Dose:12.5/50 mcg & 12.5/100 mcg
Route:Oral inhalation
Duration:Day 0 to Day 84
Frequency: 2 actuations/once daily
Intervention
Vilanterol, Umeclidinium and Fluticasone furoate inhalation
Dose:12.5/31.25/50 mcg & 12.5/31.25/100 mcg)
Route:Oral inhalation
Duration:Day 0 to Day 84
Frequency: 2 actuations/once daily
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 30% to 80% of the predicted normal value at screening.
4)Patients with bronchodilator reversibility i.e., increase in FEV1 of more than 12% and more than 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 more than 6 weeks prior to screening.
6)Patients who are symptomatic at screening defined as Asthma Control Test (ACT) score less than equal to 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 beta2 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)Suspected or confirmed bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear within 4 weeks prior to screening.
7)Patients with concurrent respiratory disorder other than asthma such as but not limited to pneumonia, pulmonary tuberculosis, chronic bronchitis, chronic obstructive pulmonary disease, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pneumothorax, atelectasis, bronchopulmonary dysplasia, interstitial lung disease, cystic fibrosis
8)Clinical evidence of oropharyngeal candidiasis at screening
9)Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy
10)Patients with hepatic dysfunction (serum transaminases greater than equal to 3 x Upper Normal Limit) or renal dysfunction (blood bilirubin or serum creatinine greater than equal to 1.5 x Upper Normal Limit) at screening
11)Patients who have used prohibited medications
12)Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
13)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
14)Patients with continuing history of alcohol and/or drug abuse
15)Participation in another clinical trial within 3 months prior to screening
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
Baseline to end of study
Secondary Outcome
Outcome
TimePoints
Change from baseline in trough FEV1 at week 4
Baseline to week 4
Change from baseline in trough FVC
Baseline , week 4 and end of study
Change from baseline in post-bronchodilator FEV1 and FVC
Baseline , week 4 and end of study
Change from baseline in the ACT score
Baseline to week 4, week 8 and end of study
Use of rescue medication during the treatment period
Day 0 to end of study
Asthma exacerbations reported during the study
Day 0 to end of study
Global impression of change in the disease condition by the patients
end of study
Global assessment of efficacy by the investigator
End of study
Target Sample Size
Total Sample Size="376" Sample Size from India="376" Final Enrollment numbers achieved (Total)= "376" Final Enrollment numbers achieved (India)="376"
Phase of Trial
Phase 3
Date of First Enrollment (India)
24/02/2025
Date of Study Completion (India)
30/11/2025
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
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
In this study, the efficacy and safety of our investigational triple drug FDC of VI/UMEC/FF MDI (Test drug) will be evaluated and compared with FDC of VI/FF MDI (Reference drug) in the patients with asthma who are inadequately controlled on medium-to-high dose ICS/LABA. This will help in evaluating the efficacy & safety of addition of a LAMA, Umeclidinium in patients who are already receiving ICS/LABA combination therapy for management of asthma. Both the dose strengths of the reference drug have already been approved by the Central Licensing Authority for the management of asthma. Clinical trial duration of up to 12 weeks (~3 months) is considered appropriate to demonstrate the long-term efficacy and safety of FDC of ICS/LABA/LAMA; therefore, 12 weeks treatment duration is proposed in this study. As per the recommended dosage, both the study drugs are intended for once daily (OD) dosing. Enrolled patients will be instructed to administer 2 actuations of the allocated study drug in morning. This will be a double-blind study and MDIs containing either the test drug or the reference drug will have identical physical characteristics and will be indistinguishable from each other.