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Trial record 32 of 70 for:    inhaler | Recruiting, Not yet recruiting, Available Studies | "Lung Diseases"

Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT02536508
Recruitment Status : Recruiting
First Posted : September 1, 2015
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Brief Summary:
Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Condition or disease Intervention/treatment Phase
COPD Drug: BGF MDI 320/14.4/9.6 μg Drug: GFF MDI 14.4/9.6 μg Drug: BFF MDI 320/9.6 μg Phase 3

Detailed Description:
A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Actual Study Start Date : September 22, 2015
Estimated Primary Completion Date : September 6, 2017
Estimated Study Completion Date : September 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BGF MDI (PT010) 320/14.4/9.6 μg
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) (PT010, BGF MDI)
Drug: BGF MDI 320/14.4/9.6 μg
Budesonide, Glycopyrronium, and Formoterol Fumarate
Other Name: BGF MDI
Experimental: GFF MDI (PT003) 14.4/9.6 μg
Glycopyrronium and Formoterol Fumarate (GFF) metered dose inhaler (MDI) (PT003, GFF MDI)
Drug: GFF MDI 14.4/9.6 μg
Glycopyrronium and Formoterol Fumarate
Other Name: GFF MDI
Experimental: BFF MDI (PT009) 320/9.6 μg
Budesonide and Formoterol Fumarate (BFF) metered dose inhaler (MDI) (PT009, BFF MDI)
Drug: BFF MDI 320/9.6 μg
Budesonide and Formoterol Fumarate
Other Name: BFF MDI



Primary Outcome Measures :
  1. Percent change from baseline Bone Mineral Density (BMD) of the lumbar spine measured using DEXA scans of L2-L4 at Week 52 [ Time Frame: 52 weeks ]
  2. Change from Baseline in the Lens Opacities Classification System III (LOC III) P scale (P) Score at Week 52 [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Given their signed written informed consent to participate. Must have agreed to participate in and complete the lead-in Study PT010006.(NCT02497001)

Exclusion Criteria:

Severe osteoporosis Unable to achieve an acceptable DEXA scan Inability to achieve pupil dilation to at least 6 mm Subjects with an implanted artificial intraocular lens or are scheduled to undergo cataract surgery


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): NCT02536508


Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

  Show 70 Study Locations
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
Study Director: Colin Reisner Pearl Therapeutics
Study Director: Paul Dorinsky, MD Pearl Therapeutics

Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02536508     History of Changes
Other Study ID Numbers: PT010008
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
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