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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)

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ClinicalTrials.gov Identifier: NCT02727660
Recruitment Status : Completed
First Posted : April 4, 2016
Results First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE March 30, 2016
First Posted Date  ICMJE April 4, 2016
Results First Submitted Date  ICMJE May 22, 2019
Results First Posted Date  ICMJE September 26, 2019
Last Update Posted Date September 26, 2019
Actual Study Start Date  ICMJE April 29, 2016
Actual Primary Completion Date April 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2019)
Morning Pre-dose Trough FEV1 [ Time Frame: at Week 12 ]
Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
  • Rate of moderate or severe COPD exacerbations [ Time Frame: over 52 Weeks ]
  • Morning Pre-dose Trough FEV1 [ Time Frame: at Week 24 ]
Change History Complete list of historical versions of study NCT02727660 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
  • Change From Baseline in Average Daily Rescue Ventolin HFA Use [ Time Frame: over 24 Weeks ]
  • Transient Dyspnea Index (TDI) focal score [ Time Frame: over 24 Weeks ]
  • Change from baseline in the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) total score [ Time Frame: over 52 Weeks ]
  • Percentage of subjects achieving an MCID of 4 units or more in Saint George's Respiratory Questionnaire (SGRQ) total score [ Time Frame: at Week 24 ]
  • Time to First Moderate or Severe COPD Exacerbation [ Time Frame: over 52 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disorder
Intervention  ICMJE
  • Drug: BFF MDI (PT009) 320/9.6 μg
    Blinded Treatment
    Other Name: Budesonide and Formoterol Fumarate Inhalation Aerosol
  • Drug: BFF MDI (PT009) 160/9.6 μg
    Blinded Treatment
    Other Name: Budesonide and Formoterol Fumarate Inhalation Aerosol
  • Drug: FF MDI (PT005) 9.6 μg
    Blinded Treatment
    Other Name: Formoterol Fumarate Inhalation
Study Arms  ICMJE
  • 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
    Intervention: Drug: BFF MDI (PT009) 320/9.6 μg
  • 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
    Intervention: Drug: BFF MDI (PT009) 160/9.6 μg
  • Experimental: FF MDI (PT005) 9.6 μg
    Formoterol Fumarate Inhalation Aerosol - 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
    Intervention: Drug: FF MDI (PT005) 9.6 μg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2019)
1876
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2016)
2241
Actual Study Completion Date  ICMJE April 4, 2018
Actual Primary Completion Date April 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   Russian Federation,   Argentina,   Austria,   Belgium,   Brazil,   Canada,   Denmark,   Germany,   Italy,   Mexico,   Norway,   Peru,   Puerto Rico,   South Africa,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02727660
Other Study ID Numbers  ICMJE PT009003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pearl Therapeutics, Inc.
Study Sponsor  ICMJE Pearl Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pearl Therapeutics, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP