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Effect of BDP/Formoterol/G on Cough Efficacy in Moderate to Severe COPD Patients (EFFICACE)

NCT05114434 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2021-11-10

No results posted yet for this study

Summary

This prospective, single centre, 8 weeks, open-label study is designed to evaluate in real-life the effect of triple Beclometasone/Formoterol/Glycopyrronium (BDP/F/G) therapy on cough efficacy, assessed by cough peak flow (CPF), after 8 weeks' treatment in patients with moderate to severe COPD.

The study's hypothesis is that in symptomatic moderate to severe COPD patients the administration of fixed dose combination BDP/F/G, by reducing lung hyperinflation (LH) and targeting small airways, may accordingly improve the cough efficacy. The increase in cough efficacy might in turn positively influence the quality of life of patients and underlie the prevention of acute exacerbations of COPD.

Conditions

  • COPD, Chronic Obstructive Pulmonary Disease

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    collaborator INDUSTRY

  • University of Parma

    lead OTHER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2023-03-31
Completion
2023-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05114434 on ClinicalTrials.gov