EUCTR2016-000155-28-ESActive, not recruitingPhase 1
A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assessthe Efficacy and Safety of PT009 compared to PT005 on COPDExacerbations over a 52-Week Treatment Period in Subjects With Moderateto Very Severe COPD - SOPHOS
Pearl Therapeutics, Inc. (Pearl)0 sites2,241 target enrollmentStarted: October 25, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 2,241
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Inclusion Criteria:
- •1. Give their signed written informed consent to participate
- •2. At least 40 years of age and no older than 80 years of age
- •3. Moderate to Very Severe COPD patients who are symptomatic
- •4. Must be receiving one or more inhaled bronchodilators as
- •maintenance therapy
- •5. Must have a documented history of COPD exacerbations
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1233
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1008
Exclusion Criteria
- •Exclusion Criteria:
- •1.Current diagnosis of asthma
- •2.COPD due to a1-Antitrypsin Deficiency
- •3. Known active tuberculosis, lung cancer, cystic fibrosis, and significant
- •bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery
- •during the past 6 months.
- •4. Long-term-oxygen therapy (= 15 hours a day).
Investigators
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