To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Randomized, Double-Blind, Parallel-Group, 12-Week, Chronic Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03081247
• Other study ID #: PT010017
• Status: Withdrawn
• Phase: Phase 3
• Start date: April 16, 2018
• Est. completion date: December 7, 2018

Study information

• Verified date: July 2018
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD.

Description:

This is a multicenter, randomized, double-blind, parallel-group, 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD. The study has a total of 7 visits over a Screening Period of up to 28 days and a Treatment Period of 12 weeks followed by a telephone follow-up call 14 days after the last dose of study drug.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 7, 2018
• Est. primary completion date: December 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Key Inclusion Criteria:

• Signed Informed Consent

• Subjects with an established clinical history of COPD

• Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <80% predicted normal value

• All subjects must have been on 2 or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening

• Current or former smokers with a history of at least 10 pack-years of cigarette smoking

• Women of Non-childbearing potential

• Women of childbearing potential and sexually active agree to prevent pregnancy by using acceptable contraceptive methods consistently

Key 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

• Current diagnosis of asthma

• Uncontrolled sleep apnea

• Other Serious Respiratory Disorders

• Hospitalized due to poorly controlled COPD within 6 weeks

• Poorly Controlled COPD

• Immune deficiency and/or severe neurological disorders affecting control of the upper airway

• Hypersensitivity to ß2-agonists, corticosteroids, or muscarinic anticholinergics

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• BGF 320/14.4/9.6 µg MDI
Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)
• BFF 320/9.6 µg
Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume area under the curve from 0 to 4 hours (AUC0-4)		Week 12
Secondary	Change from baseline in morning pre-dose trough FEV1		Week 12
Secondary	Peak change from baseline in inspiratory capacity		Week 12
Secondary	Percentage of subjects achieving a minimally clinical important difference (MCID) of 4 units or more in St. George's Respiratory Questionnaire (SGRQ)		Week 12
Secondary	Time to first clinically important deterioration (CID) in COPD		12 weeks
Secondary	Change from baseline in average daily rescue Ventolin HFA use		12 weeks
Secondary	Peak change from baseline in FEV1		Week 12
Secondary	Time to onset of action		Day 1