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Efficacy and safety study of Indacaterol, inhalation capsules 150 µg in patients with COPD

International, open-label, randomized, comparative efficacy and safety study of Indacaterol, inhalation capsules 150 µg (LLC PSK Pharma, Russia) and Onbrez® Breezhaler®, inhalation capsules 150 µg (Novartis Pharma AG, Switzerland) in patients with COPD

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/030118
Enrollment
136
Registered
2020-12-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J452- Mild intermittent asthma

Interventions

Intervention1: Tradename Indacaterol Generic name Indacaterol Pharmaceutical form Inhalation Powder Capsules Manufacturer PSK Pharma LLC, Russia : Study Dosing Regime 1 capsule (150 μg) for inhalatio

Sponsors

PSK Pharma LLC
Lead Sponsor
Mudra Clincare
Collaborator

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
FEV1 variation valueTimepoint: AT 86th day—

Secondary

MeasureTime frame
Dynamics of FEV1 indicatorTimepoint: at 28th, 56th and 86th Day;Dynamics of the absolute PEF indicatorTimepoint: at 28th, 56th and 86th Day;Dynamics of the total CAT scoreTimepoint: at 28th, 56th and 86th Day—

Countries

India, Russian Federation

Contacts

Public ContactDr S Sadgune

Mudra Clincare

dr.sayalitarte@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026