A Study to Assess the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

COPD Clinical Trial

Official title:

A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Single-Center Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02643082
• Other study ID #: PT003018
• Status: Completed
• Phase: Phase 3
• Start date: December 23, 2015
• Est. completion date: January 26, 2017

Study information

• Verified date: February 2019
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance With Moderate to Severe COPD.

Description:

Enrolled patients with COPD who were randomized to receive either PT003 MDI or Placebo MDI first and then crossed over to receive the opposite intervention. The study consisted of 2 treatment periods of 14 days separated by a washout period of 5-21 days.

Other known NCT identifiers

• NCT03024346

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 26, 2017
• Est. primary completion date: January 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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 urine pregnancy test at Visit 1 and agrees to an acceptable method of contraception

• 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.

• At Visit 1, FEV1/FVC ratio must be <0.70

• At Visit 1, post-bronchodilator FEV1/FVC ratio of <70% and FEV1 must be 30% to 80% before predicted normal value, calculated using NHANES III reference equations.

Exclusion criteria:

• Significant diseases other than COPD, i.e., disease or condition 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 run-in period (Visit 1 to Visit 2).

• 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 run-in period (Visit 1 to Visit 2).

• Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated.

• Subjects who have a history of hypersensitivity to ß2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.

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

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• GFF MDI (PT003) 14.4/9.6µg
Glycopyrronium and Formoterol Fumarate
• Placebo MDI
Comparator: Placebo MDI which contains no active ingredients

Locations

Country	Name	City	State
Belgium	Research Site	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific Airway Volume (siVaw)	Specific image-based airway volume. Average across lobe, adjusted for lobe volume	Day 15
Primary	Specific Airway Resistance (siRaw)	Specific image-based airway resistance. Average across lobes, adjusted for lobe volume	Day 15
Secondary	Airway Resistance (iRaw)	iRaw represents the airway resistance, averaged across lobes, without correction for lung lobe volume	Day 15
Secondary	Airway Volume (iVaw)	iVaw represents the airway Volume, averaged across lobes, without correction for lung lobe volume	Day 15
Secondary	Change From Baseline in FEV1 (L) at Day 15	Change from baseline in Forced Expiratory Volume at 1 second	Baseline and Day 15
Secondary	Change From Baseline in FRC (L) at Day 15	Change from baseline in Functional Residual Capacity	Baseline and Day 15

External Links

•   Protocol with updated PDFA coverpage
•   Updated version per comments from CT.gov
•   Updated version per comments from CT.gov
•   Updated version per comments from CT.gov
•   Updated version per comments from CT.gov
•   Updated version per CT.gov comments
•   Updated version per CT.gov comments
•   Updated version per CT.gov comments