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Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)

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ClinicalTrials.gov Identifier: NCT01854645
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Brief Summary:
The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: GFF MDI Drug: GP MDI Drug: FF MDI Drug: Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®) Drug: Placebo MDI Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Chronic Dosing, 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 and Spiriva® Handihaler® (Tiotropium Bromide 18 µg Open-Label) as an Active Control
Study Start Date : May 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GFF MDI
Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) (PT003)
Drug: GFF MDI
GFF MDI administered as two puffs Bis in Di.e. Twice Daily (BID)

Experimental: GP MDI
Glycopyrronium (GP) MDI (PT001)
Drug: GP MDI
GP MDI administered as two puffs BID

Experimental: FF MDI
Formoterol Fumarate (FF) MDI (PT005)
Drug: FF MDI
FF MDI administered as two puffs BID

Active Comparator: Open-label tiotropium bromide inhalation powder
Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
Drug: Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
Taken as 1 capsule daily containing 18 µg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)

Placebo Comparator: Placebo
Placebo MDI
Drug: Placebo MDI
Inhaled placebo administered as two puffs BID




Primary Outcome Measures :
  1. Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 [ Time Frame: Baseline and at Week 24 ]
    Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24


Secondary Outcome Measures :
  1. Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks [ Time Frame: Baseline and Weeks 2 to 24 ]
    Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline,and a modelbased average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.

  2. St. George's Respiratory Questionnaire (SGRQ) Score [ Time Frame: Baseline and at Week 24 ]
    Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo 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. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.

  3. Rescue Ventolin Hydrofluoroalkane (HFA) Use [ Time Frame: Baseline and at Week 24 ]
    Change from baseline in average daily rescue Ventolin HFA use

  4. Onset of Action as Assessed by FEV1 [ Time Frame: Assessed for 5- and 15-minute post dose on Day 1 ]
    Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant

  5. Peak Change From Baseline in FEV1 Within 2 Hours Post-dose [ Time Frame: Baseline and at Week 24 ]
    Peak change from baseline in forced expiratory volume in 1 second (FEV1) within 2 hours post-dose



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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

Key Inclusion Criteria:

  • Male or female subjects at least 40 years of age and no older than 80 at Visit 1.
  • 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.
  • Average f the -60 and the -30 min pre-dose FEV1 assessments must be < 80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations.
  • Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol

Key Exclusion Criteria:

  • Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may put the patient 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
  • Current diagnosis of asthma or alpha-1 antitrypsin deficiency
  • Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea
  • Hospitalized due to poorly controlled COPD within 3 months prior to screening or during the Screening Period
  • Poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the Screening Period
  • Lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the Screening Period
  • Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment.
  • Recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months
  • Congestive heart failure (CHF) New York Heart Association (NYHA) Class III/IV)
  • Clinically significant abnormal 12-lead ECG
  • Abnormal liver function tests defined as aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin ≥ 1.5 times upper limit of normal at Visit 1 and on repeat testing
  • Cancer not in complete remission for at least five years
  • History of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the MDI

Other protocol-defined inclusion/exclusion criteria may apply


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): NCT01854645


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Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
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Study Director: Colin Reisner, MD Pearl Therapeutics, Inc.

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: NCT01854645     History of Changes
Other Study ID Numbers: PT003006-00
First Posted: May 15, 2013    Key Record Dates
Results First Posted: March 28, 2017
Last Update Posted: March 28, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Tiotropium Bromide
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents