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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

A study comparing two COPD treatments for effectiveness and safety.

Recruiting
40 years and older
All
Phase 3

The study aims to see how well two medicine combinations, CHF 5993 and CHF 1535, help people with a lung disease called COPD. COPD, or Chronic Obstructive Pulmonary Disease, makes it hard to breathe. This is a phase III study, meaning it’s testing how well the medicines work in a large group of people. Participants will be split into two groups randomly and won’t know which medicine they receive, a method called double-blind.

The study lasts for about 52 weeks, with check-ups every 6 weeks. Participants will use an electronic diary to record symptoms and medicine use daily. Regular tests like lung function tests and heart checks will be done.

  • This study lasts for about 1 year with regular visits every 6 weeks.
  • Participants must have COPD and be at least 40 years old.
  • Regular tests and diary entries are required.

To join, you must have had COPD for at least a year and be a current or past smoker. You can’t join if you have certain health problems or if you’re pregnant. The study checks for safety and how the medicine helps you breathe better.

Study details
    COPD
    COPD Exacerbation

NCT04320342

Chiesi Farmaceutici S.p.A.

13 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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