CTRI/2024/02/063046Active, not recruitingPhase 3
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
Zydus Healthcare Limited9 sites in 1 country256 target enrollmentStarted: March 5, 2024Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Zydus Healthcare Limited
- Enrollment
- 256
- Locations
- 9
- Primary Endpoint
- Change from baseline in trough FEV1 at the end of the study
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either gender between 18-65 years of age (both inclusive)
- •Patients diagnosed with asthma for at least 12 months prior to screening
- •Pre-bronchodilator FEV1 of 40% to 80% of the predicted normal value at screening
- •Patients with bronchodilator reversibility i.e., increase in FEV1 of ≥ 12% and ≥ 200 ml after salbutamol inhalation at screening
- •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
- •Patients who are symptomatic at screening defined as Asthma Control Test (ACT) score ≤ 15
- •Patients with a history of at least one severe asthma exacerbation within past 12 months prior to screening
- •Patients willing to provide written informed consent and comply with the protocol requirements
- •Patients literate enough to fill the diary card.
Exclusion Criteria
- •Known hypersensitivity to any β2-agonist, sympathomimetic drug, antimuscarinic agent or any inhaled, intranasal or systemic corticosteroid
- •History of life-threatening asthma within past 5 years prior to screening
- •Asthma exacerbation requiring systemic corticosteroids or that resulted in hospitalization or emergency room visit within 6 weeks prior to screening
- •Patients treated with a long-acting muscarinic antagonist within 3 months prior to screening
- •Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention
- •Patients diagnosed with COVID-19 within 3 months prior to screening
- •Suspected or confirmed bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear within 4 weeks prior to screening
- •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
- •Clinical evidence of oropharyngeal candidiasis at screening
- •Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy
- •Patients with hepatic dysfunction (serum transaminases ≥ 3 x Upper Normal Limit) or renal dysfunction (serum creatinine ≥ 2.5 mg/dl) at screening
- •Patients who have used prohibited medications
- •Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
- •Patients with continuing history of alcohol and/or drug abuse
- •Participation in another clinical trial within 3 months prior to screening
- •Any other reason for which the investigator feels that the patient should not participate.
Outcomes
Primary Outcomes
Change from baseline in trough FEV1 at the end of the study
Time Frame: Baseline to end of study
Secondary Outcomes
- Change from baseline in trough FEV1
- 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)
- Change from baseline in the ACT score(at week 4, week 8 and at the end of)
- 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)
- Safety endpoinrt- Adverse events and serious adverse events reported(During the study)
- Overall tolerability evaluation(At the end of study)
Investigators
Dr Deven V Parmar
Zydus Research Centre
Study Sites (9)
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