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)

• 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: Pearl Therapeutics, Inc.
• Information provided by (Responsible Party): Pearl Therapeutics, Inc.

Tracking Information

• First Submitted Date: March 30, 2016
• First Posted Date: April 4, 2016
• Results First Submitted Date: May 22, 2019
• Results First Posted Date: September 26, 2019
• Last Update Posted Date: September 26, 2019
• Actual Study Start Date: April 29, 2016
• Actual Primary Completion Date: April 4, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: 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: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Chronic Obstructive Pulmonary Disorder

Intervention

• 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

• 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 *: Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 3, 2019): 1876
• Original Estimated Enrollment (submitted: March 30, 2016): 2241
• Actual Study Completion Date: April 4, 2018
• Actual Primary Completion Date: April 4, 2018 (Final data collection date for primary outcome measure)

Eligibility 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. 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

• Sexes Eligible for Study: All

• Ages: 40 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Austria, Belgium, Brazil, Canada, Chile, Denmark, Germany, Italy, Mexico, Norway, Peru, Puerto Rico, Russian Federation, South Africa, Spain, Sweden, United Kingdom, United States

Administrative Information

• NCT Number: NCT02727660
• Other Study ID Numbers: PT009003
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Pearl Therapeutics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Pearl Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Pearl Therapeutics, Inc.
• Verification Date: August 2019