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)

Overview

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.

Full Title of Study: “A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 4, 2018

Detailed Description

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 weeks.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: BFF MDI (PT009) 320/9.6 μg
    • Budesonide and Formoterol Fumarate Inhalation Aerosol – 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
  • Experimental: BFF MDI (PT009) 160/9.6 μg
    • Budesonide and Formoterol Fumarate Inhalation Aerosol – 80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
  • Experimental: FF MDI (PT005) 9.6 μg
    • Formoterol Fumarate Inhalation Aerosol – 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID

Clinical Trial Outcome Measures

Primary Measures

  • Morning Pre-dose Trough FEV1
    • Time Frame: at Week 12
    • Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12

Secondary Measures

  • Time to First Moderate or Severe COPD Exacerbation
    • Time Frame: over 52 weeks
    • Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation over 52 weeks
  • Change From Baseline in Average Daily Rescue Ventolin HFA Use
    • Time Frame: over 12 weeks
    • Change from baseline in average daily rescue Ventolin HFA use over 12 weeks
  • Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George’s Respiratory Questionnaire (SGRQ) Total Score
    • Time Frame: at Week 12
    • The SGRQ (St. George’s Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI on health-related quality of life as compared to FF MDI in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. A decrease from baseline in SGRQ total score of 4 units or more is considered a clinically meaningful improvement in quality of life.

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pearl Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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