Efficacy and safety study of Indacaterol, inhalation capsules 150 µg in patients with COPD
Phase 3
- Conditions
- Health Condition 1: J452- Mild intermittent asthma
- Registration Number
- CTRI/2020/12/030118
- Lead Sponsor
- PSK Pharma LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.The presence of a signed Informed Consent Form of Patient Information Sheet (PIS) for participation in a clinical study.
2.Male and female patients aged 40â??70 years old inclusive at the time of signing the Informed Consent Form of PIS.
3.A diagnosis of moderate-grade COPD, established according to the GOLD guidelines, 2018, at least 12 months before the screening visit.
4.Patients corresponding to group B, according to GOLD, 2018
Exclusion Criteria
1.Patients requiring initial treatment for COPD.
2.Hypersensitivity to indacaterol or any of the components of the drug.
3.Lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
4.Demand for excessive use of SABAs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method