A Study to Assess the Efficacy and Safety of PT009 compared to PT005 in Subjects with Moderate to Very Severe COPD (Sophos)
- Conditions
- Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 21.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2016-000155-28-IT
- Lead Sponsor
- PEARL THERAPEUTICS, INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1843
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 1023
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 837
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Over 12 weeks;Main Objective: ¿To assess the effects of BFF MDI relative to FF MDI on lung function<br>;Secondary Objective: ¿To assess the effects of BFF MDI relative to FF MDI on COPD exacerbations<br>¿To assess the effects of BFF MDI relative to FF MDI on symptoms of COPD<br>¿To assess the effects of BFF MDI relative to FF MDI on quality of life<br>;Primary end point(s): Morning pre-dose trough FEV1
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Transient Dyspnea Index (TDI) focal score; Change from baseline in the Exacerbations of Chronic Pulmonary<br>Disease Tool (EXACT) total score; Time to first moderate or severe COPD exacerbation; Time to first clinically important deterioration in COPD; Change from baseline in average daily rescue Ventolin HFA use ; Percentage of subjects achieving an MCID of 4 units or more in Saint George's Respiratory Questionnaire (SGRQ) total score ;Timepoint(s) of evaluation of this end point: over 24 weeks; over treatment period; At time of occurrence; At time of occurence; Over 24 weeks; Over 24 weeks