A Randomized, Double Blind, Multi Center, Parallel Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations over a 52 Week Treatment Period in Subjects With Moderate to Very Severe COPD

Phase 3

Completed

• Conditions: chronic lung disease; Chronic Obstructive Pulmonary Disease; 10038716

• Registration Number: NL-OMON47721
• Lead Sponsor: Pearl Therapeutics, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 126

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.

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 (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).
* 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 *2-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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Rate of moderate or severe COPD exacerbations</p><br>