CTRI/2024/02/063046 [Registered on: 22/02/2024] 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 assess the efficacy and safety of Vilanterol, Glycopyrronium and Fluticasone furoate powder for inhalation as compared to Indacaterol, Glycopyrronium and Mometasone furoate powder for inhalation in patients with asthma
Scientific Title of Study
A prospective, randomized, parallel, activecontrolled,
multicentre, phase III clinical trial to
assess the efficacy and safety of Vilanterol,
Glycopyrronium and Fluticasone furoate
powder for inhalation as compared to
Indacaterol, Glycopyrronium and Mometasone
furoate powder for inhalation in patients with
persistent asthma
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
23-05 Version No. 00 Date: 24/08/2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
5, Anveshan Row House, Opp Umiya Mata Mandir Bopal-Ghuma Main Road, Bopal Ahmedabad
Ahmadabad
GUJARAT 380058
Ahmadabad GUJARAT
9825182251
drchintan.cr@gmail.com
Dr Deepak Kumar R
Abhayahasta Multispeciality Hospital
Department of Respiratory Diseases, Abhayahasta Multispeciality Hospital, 347/247, 2nd Cross, Kaggadasapura, Main Road,CV Raman Nagar,Bengaluru-93, Karnataka Bangalore KARNATAKA
9980700770
cr@abhayahastahospital.com
Dr Ravi Koppula
Government Medical College & Government General Hospital (Old RIMSGGH)
Department of Pulmonology, OPD No:14, 1st Floor, Government Medical College & Government General Hospital (Old RIMSGGH), Srikakulam-532001, Andhra Pradesh Srikakulam ANDHRA PRADESH
7995881980
bioexperts21@gmail.com
Dr Amit S Bhate
Jeevan Rekha Hospital
Jeevan Rekha Hospital, Near Nagshanti Motor Showroom,Veer Chamber, Opp. Civil Hospital and Dr. B.R. Ambedkar Road,Belagavi-590002 Belgaum KARNATAKA
Medical and College and hospital,MCH building,4th floor,88 college street,Kolkata-700073,West Bengal,India Kolkata WEST BENGAL
9232467518
drasish84@gmail.com
Dr Avdhesh Kumar
Murari Lal Chest Hospital
Department of Pulmonology, Murari Lal Chest Hospital, GSVM Medical College, Kanpur-208002, Uttar Pradesh Kanpur Nagar UTTAR PRADESH
7408441504
dravikumar1001@gmail.com
Dr Diptikant Sahoo
Shanti Memorial Hospital Pvt. Ltd.
Department of Pulmonary Medicine,Patnaik colony,Thoria
Sahi,Cuttack-753001 Cuttack ORISSA
7325939490
diptikant07@gmail.com
Dr Vaishal Sheth
Sheth Vadilal Sarabhai General Hospital and Sheth Chinai Maternity Hospital
Sheth Vadilal Sarabhai
General Hospital and Sheth Chinai Maternity Hospital,OPD block, first floor,
Trauma Centre,
Department of
Medicine,Ellis bridge,
Ahmedabad – 380006 Ahmadabad GUJARAT
Indacaterol, Glycopyrronium and
Mometasone furoate powder for inhalation
150 mcg, 50 mcg and 160 mcg
Comparator product, Indacaterol, Glycopyrronium and Mometasone furoate (150 mcg, 50 mcg and 160 mcg) powder for inhalation in form of capsule to be consumed once a day through inhalation using respihaler device for total 12 weeks.
Intervention
Vilanterol, Glycopyrronium and
Fluticasone Furoate powder for inhalation 25
mcg, 50 mcg and 200 mcg
Test product, Vilanterol, Glycopyrronium and Fluticasone Furoate (25 mcg, 50 mcg and 200 mcg) powder for inhalation in form of capsule to be consumed once a day through inhalation using respihaler device for total 12 weeks.
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, antimuscarinic
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 effective contraception
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
Not Applicable
Blinding/Masking
Open Label
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
Change from baseline in trough FVC
at week 4 and at the end of the study
Change from baseline in post-bronchodilator FEV1 and FVC
at week 4 and at
the end of the study
Change from baseline in the ACT score
at week 4, week 8 and at the end of
the study
Proportion of rescue medication free days
during the treatment period
Asthma exacerbations reported
during the study
Global impression of change in the disease condition by the patients
at the
end of the study
Safety endpoinrt- Adverse events and serious adverse events reported
During the study
Overall tolerability evaluation
At the end of study
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 powder for inhalation as
compared to Indacaterol, Glycopyrronium and Mometasone furoate powder for
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 FDC
of Vilanterol 25 mcg, Glycopyrronium 50 mcg and Fluticasone furoate 200
mcg DPI as compared to FDC of Indacaterol 150 mcg, Glycopyrronium 50 mcg
and Mometasone furoate 160 mcg DPI in patients with persistent asthma and
secondary objective is to evaluate the safety of FDC of Vilanterol 25 mcg,
Glycopyrronium 50 mcg and Fluticasone furoate 200 mcg DPI as compared to
FDC of Indacaterol 150mcg, Glycopyrronium 50 mcg and Mometasone furoate 160 mcg
DPI in patients with persistent asthma