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
- Conditions
- Health Condition 1: J453- Mild persistent asthma
- Registration Number
- CTRI/2024/02/063046
- Lead Sponsor
- Zydus Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
1. Known hypersensitivity to any ß2-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in trough FEV1 at the end of the studyTimepoint: Baseline to end of study
- Secondary Outcome Measures
Name Time Method Asthma exacerbations reportedTimepoint: during the study;Change from baseline in post-bronchodilator FEV1 and FVCTimepoint: at week 4 and at <br/ ><br>the end of the study;Change from baseline in the ACT scoreTimepoint: at week 4, week 8 and at the end of <br/ ><br>the study;Change from baseline in trough FEV1 <br/ ><br>Timepoint: At week 4;Change from baseline in trough FVCTimepoint: at week 4 and at the end of the study;Global impression of change in the disease condition by the patientsTimepoint: at the <br/ ><br>end of the study;Overall tolerability evaluationTimepoint: At the end of study;Proportion of rescue medication free daysTimepoint: during the treatment period;Safety endpoinrt- Adverse events and serious adverse events reportedTimepoint: During the study