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A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD

Comparing two COPD treatments: CHF 5993 vs. CHF 1535.

Recruiting
40 years and older
All
Phase 3

This study is comparing two medicines, CHF 5993 and CHF 1535, to see which one works better and is safer for people with Chronic Obstructive Pulmonary Disease (COPD). COPD is a lung disease that makes it hard to breathe. The study will last for 52 weeks. Participants will be checked after 4 weeks and then every 6 weeks. They will keep a daily electronic diary to record symptoms and medicine use, and will have tests like spirometry (a breathing test) and blood tests.

Key Points:

  • Participants will need to attend several study visits over a year.
  • Participants will record daily symptoms using an electronic diary.
  • Eligibility requires a COPD diagnosis and being a non-smoker or ex-smoker.

The study involves taking medicine through an inhaler and regular health checks. It's important for participants to have a cooperative attitude and be able to use the inhaler and diary correctly. This study is not for people with certain medical conditions, such as other serious lung diseases or recent major surgeries. Participants should not be pregnant, and certain medications must be avoided before joining.

Study details
    COPD
    COPD Exacerbation

NCT04320342

Chiesi Farmaceutici S.p.A.

13 December 2024

Step 1 Get in touch with the nearest study center
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