[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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Study’s contact

Call center

+39 0521 279 715

Email address

clinicaltrials_info@chiesi.com

Condition

Chronic Obstructive Pulmonary Disease

Treatment type

Interventional

Investigational product

CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo

Phase

Phase 3

Sponsor

Chiesi Farmaceutici S.p.A.

ClinicalTrials.gov identifier

NCT03888131

Study number

CCD-01535AC1-02

Understanding clinical trials

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About the study

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 take part?

You may be eligible to participate in the study if you meet the following criteria:

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

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site