Health Condition 1: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Indacaterol/Glycopyrronium/Mometasone (FDC) DPI: Total treatment Duration is 24 weeks.
Dosage Form: Capsule for dry powder Inhalation
Dose: One capsule to be inhaled once daily.
Dosage
Sponsors
Lupin Limited
Eligibility
Inclusion criteria
Inclusion criteria: i. Patients aged between 18 - 65 years (both inclusive) of either gender diagnosed with bronchial asthma and eligible to receive Indacaterol/Glycopyrronium/Mometasone (FDC) DPI ii. Reversibility FEV1 of at least 12% and 200 mL iii. Pre-bronchodilator FEV1 of 40-90% predicted normal iv. Currently using ICS ± SABA/LABA, for at least 4 weeks prior to 1st visit. v. Patient willing to give a written informed consent
Exclusion criteria
Exclusion criteria: I. Refusal to participation expressed by patient. II. History of life-threatening asthma or more than four separate exacerbations or more than two hospitalizations for asthma in the previous year. III. Smoking history of more than 10 pack-years IV. Pregnant or lactating women. V. Patients who have participated in any clinical trial within 30 days prior to enrolment and would not be participating in clinical study during the period of study participation. VI. History of known hypersensitivity to any individual study drug of the study drug combination or to any of the excipient present in the dosage form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety & tolerability of Indacaterol/Glycopyrronium/Mometasone (FDC) DPI in treatment of patients with asthma in India in terms of -Timepoint: Incidence rate of adverse events AEs Number of treatment related TEAEs STEAEs Time Frame up to Week 24 •Number of episodes of exacerbations mild moderate severe over 24 weeks Time frame 24 weeks •Tolerability of the drug Time frame24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of Indacaterol/Glycopyrronium/Mometasone (FDC) DPI for in treatment of patients with asthma in India in terms of -Timepoint: • Mean change in ACQ-7 score from baseline [Time frame: 24 weeks] • Mean change in FEV1, FVC & ratio of FEV1/FVC from baseline [Time frame: 24 weeks] • Proportion of Patients requiring hospitalization [Time frame: 24 weeks] • Rescue Medication use averaged over 24 weeks of treatment • Compliance with the study medication. [Time frame: At week 24] • Assessment of patients satisfaction with the treatment [Time frame: 24 weeks] | — |
Countries
India
Contacts
Public ContactManoj Karwa
Lupin Limited
Outcome results
None listed