Study of effect of CSJ117 on symptoms, pharmacodynamics and safety in patients with COPD

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease; MedDRA version: 21.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-000692-36-HU
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-01
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

--Male and female COPD patients aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
--Current or ex-smokers who have a smoking history of at least 10 pack years
--Patients who have been treated with a triple combination of LABA/LAMA/ICS for the last 3 months prior to screening
--Patients with a documented diagnosis of COPD for at least 1 year prior to screening visit

Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

--Patients with a past or current medical history of asthma
--Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization, or a respiratory tract infection in the 4 weeks prior to screening, or hospitalization between screening and prior to treatment.
--Use of other investigational drugs (approved or unapproved) within 30 days or 5 half-lives prior to screening, or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics),
whichever is longer; or longer if required by local regulations
--Pregnant or nursing (lactating) women, and women of childbearing potential not willing to use acceptable effective methods of contraception during study participation
-Patients with a body mass index (BMI) of more than 40 kg/m2

Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified