A Study to Assess the Efficacy and Safety of PT009 compared to PT005 onCOPD Exacerbations over a 52-Week Period in Subjects with Moderate toVery Severe COPD (sophos)

Phase 1

Conditions: Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
MedDRA version: 19.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2016-000155-28-ES

Lead Sponsor: Pearl Therapeutics, Inc. (Pearl)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2241

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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To assess the effects of BFF MDI relative to FF MDI on COPD<br>exacerbations<br>• To assess the effects of BFF MDI relative to FF MDI on lung function;Secondary Objective: • To assess the effects of BFF MDI relative to FF MDI on symptoms of<br>COPD<br>• To assess the effects of BFF MDI relative to FF MDI on quality of life<br>• To assess the effects of BFF MDI on COPD exacerbations;Primary end point(s): 1. Rate of moderate or severe COPD exacerbations<br>2. Morning pre-dose trough FEV1;Timepoint(s) of evaluation of this end point: 1. over 52 Weeks<br>2. Over 24 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change from baseline in average daily rescue Ventolin HFA use<br>2. Transient Dyspnea Index (TDI) focal score<br>3. Change from baseline in the Exacerbations of Chronic Pulmonary<br>Disease Tool (EXACT) total score<br>4. Percentage of subjects achieving an MCID of 4 units or more in Saint<br>George's Respiratory Questionnaire (SGRQ) total score<br>5. Time to first moderate or severe COPD exacerbation;Timepoint(s) of evaluation of this end point: 1. Over 24 weeks<br>2. Over 24 weeks<br>3. Over 52 weeks<br>4. Over 24 weeks<br>5. At time of occurance