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Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD

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ClinicalTrials.gov Identifier: NCT02343458
Recruitment Status : Completed
First Posted : January 22, 2015
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Brief Summary:
A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI; PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with placebo.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: GFF MDI (PT003) Drug: FF MDI (PT005) Drug: GP MDI (PT001) Drug: Placebo MDI Phase 3

Detailed Description:
A randomized, double-blind, chronic dosing (24 weeks), placebo-controlled, parallel group, multi-center study to assess the efficacy and safety of glycopyrronium and formoterol fumarate inhalation aerosol (GFF; PT003), formoterol fumarate inhalation aerosol (FF; PT005), and glycopyrronium inhalation aerosol (GP; PT001) in subjects with moderate to very severe COPD, compared with placebo.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1759 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo
Actual Study Start Date : March 30, 2015
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GFF MDI (PT003)
Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Drug: GFF MDI (PT003)
Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Other Name: Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol

Experimental: FF MDI (PT005)
Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Drug: FF MDI (PT005)
Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Other Name: Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol

Experimental: GP MDI (PT001)
Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Drug: GP MDI (PT001)
Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Other Name: Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol

Placebo Comparator: Placebo MDI
Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)
Drug: Placebo MDI
Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)
Other Name: Placebo (matching) for GFF MDI, FF MDI, and GP MDI




Primary Outcome Measures :
  1. Change from baseline in morning pre-dose trough FEV1 of treatment [ Time Frame: At Week 24 ]
    Assessed at week 24 for US/China and over weeks 12-24 for Japan, and over 24 weeks for EU/South Korea/Taiwan


Secondary Outcome Measures :
  1. TDI score [ Time Frame: 24 Weeks ]
    Assessed over 24 weeks for US/China and EU/South Korea/Taiwan. Assessed over weeks 12-24 for Japan.

  2. Change from baseline in morning pre-dose trough FEV1 [ Time Frame: Over 24 Weeks ]
    Assessed over 24 weeks for US/China

  3. Peak change from baseline in FEV1 within 2 hours post-dosing [ Time Frame: 24 weeks ]
    Assessed at Week 24 for US and China. Assessed over 12-24 weeks for Japan. Assessed over 24 weeks for EU, South Korea, and Taiwan.

  4. Change from baseline in SGRQ total score [ Time Frame: 24 weeks ]
    Assessed at Week 24 for US/China. Assessed over Weeks 12-24 for EU/South Korea/Taiwan/Japan

  5. Change from baseline in average daily rescue Ventolin (albuterol sulfate) HFA use [ Time Frame: Over 24 Weeks ]
  6. Time to onset of action on Day 1 (All) [ Time Frame: Day 1 ]
    1st timepoint at which active treatment is significantly improved from placebo

  7. TDI score in Symptomatic Population [ Time Frame: 24 weeks ]
    Assessed Over 24 Weeks for US/China and EU/South Korea/Taiwan. Assessed over weeks 12-24 for Japan.

  8. Change from baseline in SGRQ total score in the Symptomatic Population [ Time Frame: 24 weeks ]
    Assessed At Week 24 for US/China. Assessed over weeks 12-24 for Japan and EU/South Korea/Taiwan.



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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:

  • Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
  • Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS).
  • Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
  • Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of <0.70.
  • FEV1 must be <80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations. (Or reference norms applicable to other regions).

Exclusion Criteria:

  • Significant diseases other than COPD, ie, disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
  • Women who are pregnant or lactating or women of childbearing potential who are not using an acceptable method of contraception.
  • Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
  • Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
  • Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
  • Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible.
  • Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.

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): NCT02343458


  Show 46 Study Locations
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
Study Chair: Colin Reisner, MD Pearl Therapeutics, Inc.

Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02343458     History of Changes
Other Study ID Numbers: PT003014
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AstraZeneca's policy is to share data with researchers if the request is in scope of our policy. The policy and additional information can be found on astrazenecaclinicaltrials.com.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pearl Therapeutics, Inc.:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
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