Health Condition 1: J455- Severe persistent asthma
Conditions
Interventions
Intervention1: 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 dai
Sponsors
Zydus Healthcare Limited,
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in trough FEV1 at the end of the studyTimepoint: Baseline to end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in trough FEV1 at week 4Timepoint: Baseline to week 4;Change from baseline in trough FVCTimepoint: Baseline , week 4 and end of study;Change from baseline in post-bronchodilator FEV1 and FVCTimepoint: Baseline , week 4 and end of study;Change from baseline in the ACT scoreTimepoint: Baseline to week 4, week 8 and end of study;Use of rescue medication during the treatment periodTimepoint: Day 0 to end of study;Asthma exacerbations reported during the studyTimepoint: Day 0 to end of study;Global impression of change in the disease condition by the patientsTimepoint: end of study;Global assessment of efficacy by the investigatorTimepoint: End of study | — |
Countries
India
Contacts
Public ContactDr Pavankumar Daultani
Zydus Research Centre
Outcome results
None listed