Phase IV post marketing study for evaluation of safety and effectiveness of Indacaterol/Glycopyrronium/Mometasone (FDC) DPI in asthmatic patients

Phase 4

Recruitment & Eligibility

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

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

Primary Outcome Measures

Name	Time	Method
To evaluate the safety & tolerability of <br/ ><br>Indacaterol/Glycopyrronium/Mometasone (FDC) DPI in treatment of <br/ ><br>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 <br/ ><br>•Number of episodes of exacerbations mild moderate severe <br/ ><br>over 24 weeks Time frame 24 weeks <br/ ><br>•Tolerability of the drug Time frame24 weeks <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of <br/ ><br>Indacaterol/Glycopyrronium/Mometasone (FDC) DPI for in treatment of <br/ ><br>patients with asthma in India in terms of -Timepoint: • Mean change in ACQ-7 score from baseline [Time frame: 24 <br/ ><br>weeks] <br/ ><br>• Mean change in FEV1, FVC & ratio of FEV1/FVC from <br/ ><br>baseline [Time frame: 24 weeks] <br/ ><br>• Proportion of Patients requiring hospitalization [Time frame: 24 <br/ ><br>weeks] <br/ ><br>• Rescue Medication use averaged over 24 weeks of treatment <br/ ><br>• Compliance with the study medication. [Time frame: At week <br/ ><br>24] <br/ ><br>• Assessment of patients satisfaction with the treatment [Time <br/ ><br>frame: 24 weeks] <br/ ><br>