CTRI/2020/12/030118Not yet recruitingPhase 3
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
PSK Pharma LLC0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
Investigators
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