CompletedPhase 3

Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient

China750 participantsStarted 2018-07-30

Plain-language summary

The purpose of the study is to demonstrate the non-inferiority of CHF1535 pMDI versus Symbicort® Turbohaler® in terms of lung function parameters and patients reported outcomes and to assess its safety and tolerability.

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged ≥ 40 years, Chinese ethnicity * Patients with COPD diagnosed at least 12 months before the screening visit. * A smoking history of at least 10 pack years * Post-bronchodilator FEV1 \< 50% of the predicted normal value * Post-bronchodilator FEV1/FVC ratio \< 0.7 * One exacerbation in the 12 months prior the screening visit Exclusion Criteria: * Patients requiring OCS/antibiotics/PDE inhibitors in the 4 weeks prior to screening * COPD exacerbation requiring OCS/antibiotics or hospitalization during the run-in period * Known respiratory disorders other than COPD * Diagnosis of asthma

What they're measuring

Demonstration of the non-inferiority of CHF 1535 pMDI versus Symbicort® Turbohaler® in terms of pulmonary function

Timeframe: At week 24

Trial details

NCT IDNCT03888131

SponsorChiesi Farmaceutici S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-06

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