Trial Search Results

A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Pearl Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: BFF MDI (PT009) 320/9.6 μg
  • Drug: BFF MDI (PT009) 160/9.6 μg
  • Drug: FF MDI (PT005) 9.6 μg

Phase:

Phase 3

Eligibility


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. 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

Exclusion Criteria:

   1. Current diagnosis of asthma

   2. COPD due to α1-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).

Ages Eligible for Study

40 Years - 80 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting