Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations in Subjects With Moderate to Very Severe COPD

Phase 1

• Conditions: Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 21.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855; MedDRA version: 21.1 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-005671-92-AT
• Lead Sponsor: Pearl Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-10
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 8400

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 (FEV1)/Forced vital capacity (FVC) ratio of <0.70 and FEV1 of <65% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions). Note: This criteria applies to subjects in the
PFT sub-study only.
• Subjects with history of exacerbations. Please refer to the study protocol for the complete inclusion criteria list.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4620
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3780

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 6 weeks prior to Visit 1 (Screening) with less then a 4 weeks washout of corticosteriods and/or antibiotics prior to Visit 1 (Screening).
• 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) with less than a 4 week washout of corticosteriods and/or antibiotics prior to Visit 1 (Screening).
• 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 ß2-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified