Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02727660
Recruitment Status : Completed
First Posted : April 4, 2016
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1941 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 : March 30, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Rate of moderate or severe COPD exacerbations [ Time Frame: over 52 Weeks ]
  2. Morning pre-dose trough FEV1 [ Time Frame: at Week 24 ]

Secondary Outcome Measures :
  1. Change from baseline in average daily rescue Ventolin HFA use [ Time Frame: over 24 Weeks ]
  2. Transient Dyspnea Index (TDI) focal score [ Time Frame: over 24 Weeks ]
  3. Change from baseline in the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) total score [ Time Frame: over 52 Weeks ]
  4. 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 ]
  5. Time to first moderate or severe COPD exacerbation [ Time Frame: over 52 Weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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).

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


  Show 283 Study Locations
Sponsors and Collaborators
Pearl Therapeutics, Inc.

Layout table for additonal information
Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02727660     History of Changes
Other Study ID Numbers: PT009003
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018

Keywords provided by Pearl Therapeutics, Inc.:
COPD

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Respiratory Tract Diseases
Formoterol Fumarate
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists