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Trial record 41 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With COPD Compared With Symbicort® Turbohaler®

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: NCT03262012
Recruitment Status : Completed
First Posted : August 25, 2017
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Brief Summary:
A Randomized, Double-Blind, Parallel Group, 28-Week Chronic Dosing, Multi-Center Long-term Extension Study to Assess the Safety and Efficacy in Japanese Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) compared with Symbicort® Turbohaler®

Condition or disease Intervention/treatment Phase
COPD Drug: BGF MDI (PT010) Drug: GFF MDI (PT003) Drug: BFF MDI (PT009) Drug: Symbicort® Turbohaler® Inhalation Powder Phase 3

Detailed Description:
This is a multicenter, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week, safety extension of Study PT010006 to assess the safety and efficacy of BGF MDI, GFF MDI, BFF MDI, and Symbicort TBH as an active control over a 52-week period in Japanese subjects with moderate to very severe COPD who remain symptomatic on maintenance treatment with either an ICS and one or more bronchodilator(s) or two or more maintenance bronchodilators.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 347 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, 28-Week, Chronic-Dosing, Multi-Center, Extension Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) Compared With Symbicort® Turbuhaler® as an Active Control
Actual Study Start Date : August 9, 2016
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : June 15, 2018

Arm Intervention/treatment
Experimental: BGF MDI (PT010)
Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010
Drug: BGF MDI (PT010)
Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010
Other Name: BGF

Experimental: GFF MDI (PT003)
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003
Drug: GFF MDI (PT003)
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003
Other Name: GFF

Experimental: BFF MDI (PT009)
Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009
Drug: BFF MDI (PT009)
Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009
Other Name: BFF

Active Comparator: Symbicort® Turbohaler® Inhalation Powder
Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler
Drug: Symbicort® Turbohaler® Inhalation Powder
Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler
Other Name: Symbicort




Primary Outcome Measures :
  1. Evaluate the long-term safety and tolerability of BGF MDI, GFF MDI, BFF MDI, & Symbicort Turbuhaler (TBH) in Japanese subjects with moderate to very severe COPD by collecting Adverse Events, 12-Lead ECGs, Laboratory testing, & Vital sign measurements. [ Time Frame: 52 Weeks ]
    Evaluate the long-term safety and tolerability of BGF MDI, GFF MDI, BFF MDI, and Symbicort Turbuhaler (TBH) in Japanese subjects with moderate to very severe COPD



Information from the National Library of Medicine

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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

  • Given their signed written informed consent to participate.
  • Subjects must have agreed to participate and complete the lead-in Study PT010006.
  • 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), or other local applicable guidelines.
  • Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
  • Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <80% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions).
  • Required COPD maintenance therapy:
  • All Subjects must have been on two or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening. Scheduled SABA and/or scheduled SAMA are considered inhaled maintenance therapies.

Please refer to the study protocol for the complete inclusion criteria list.

Exclusion Criteria

  • Significant diseases or conditions other than COPD, 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 are planning to become pregnant during the course of the study, 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
  • 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
  • Immune suppression or severe neurological disorders affecting control of the upper airway or other risk factors that in the opinion of the Investigator would put the subject at substantial risk of pneumonia.
  • Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the Investigator, have not been adequately treated.
  • Subjects who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any other component of the IMPs.

Please refer to the study protocol for the complete exclusion criteria list.


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): NCT03262012


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Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
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Study Director: Paul M. Dorinsky, MD Pearl Therapeutics, Inc.

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Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03262012     History of Changes
Other Study ID Numbers: PT010007
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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.: Yes

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