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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disorder Drug: BFF MDI (PT009) 320/9.6 μg Drug: BFF MDI (PT009) 160/9.6 μg Drug: FF MDI (PT005) 9.6 μg Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1876 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 29, 2016
Actual Primary Completion Date : April 4, 2018
Actual Study Completion Date : April 4, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 Drug: BFF MDI (PT009) 320/9.6 μg
Blinded Treatment
Other Name: Budesonide and Formoterol Fumarate Inhalation Aerosol
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
 Drug: BFF MDI (PT009) 160/9.6 μg
Blinded Treatment
Other Name: Budesonide and Formoterol Fumarate Inhalation Aerosol
Experimental: FF MDI (PT005) 9.6 μg
Formoterol Fumarate Inhalation Aerosol - 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
 Drug: FF MDI (PT005) 9.6 μg
Blinded Treatment
Other Name: Formoterol Fumarate Inhalation


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727660


Locations
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Sponsors and Collaborators
Pearl Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Pearl Therapeutics, Inc.:
Study Protocol  [PDF] January 8, 2018
Statistical Analysis Plan  [PDF] February 9, 2018

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02727660    
Other Study ID Numbers: PT009003
First Posted: April 4, 2016    Key Record Dates
Results First Posted: September 26, 2019
Last Update Posted: September 26, 2019
Last Verified: August 2019
Keywords provided by Pearl Therapeutics, Inc.:
COPD
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Budesonide
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
 Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action