Crossover Study to Assess the Efficacy of PT003 With and Without a Valved Holding Chamber in Subjects With Moderate to Severe COPD

COPD Clinical Trial

Official title:

A Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multicenter, Crossover Study to Assess the Efficacy, Safety and Pharmacokinetics of PT003 in Subjects With Moderate to Very Severe COPD With and Without a Valved Holding Chamber

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454959
• Other study ID #: PT003013
• Status: Completed
• Phase: Phase 3
• First received: May 13, 2015
• Last updated: March 3, 2017
• Start date: May 1, 2015
• Est. completion date: March 25, 2016

Study information

• Verified date: March 2017
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multi-center, Crossover Study to Assess the Efficacy of PT003 in Subjects with Moderate to Severe COPD with and without a Valved Holding Chamber.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 25, 2016
• Est. primary completion date: March 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• At least 40 years of age and no older than 80 at Screening

• Women of non-child bearing potential or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly Screening until 14 days after final visit.

• 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

• Pre- and post-bronchodilator FEV1/FVC ratio of <0.70

• Post-bronchodilator FEV1 must be <80% predicted normal value, calculated using NHANES III reference equations, and the measured FEV1 must also be =30% of predicted normal value.

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 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 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 Screening or during the Screening Period.

• Subjects who have clinically significant uncontrolled hypertension.

• Subjects who have cancer that has not been in complete remission for at least five years.

• Subjects with abnormal liver function tests defined as AST, ALT, or total bilirubin =1.5 times upper limit of normal at Screening and on repeat testing.

• Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible.

• Subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator. Subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening are excluded from the study.

• Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator.

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• GFF MDI (PT003) with Aerochamber
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) with Aerochamber Plus Valved Holding Chamber
• GFF MDI (PT003) without Aerochamber
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) without Aerochamber Plus Valved Holding Chamber

Locations

Country	Name	City	State
United States	Pearl Investigative Site	Charlotte	North Carolina
United States	Pearl Investigative Site	Clearwater	Florida
United States	Pearl Investigative Site	Gaffney	South Carolina
United States	Pearl Investigative Site	Tampa	Florida
United States	Pearl Investigative Site	Winston-Salem	North Carolina
United States	Pearl Investigative Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve for change from baseline in forced expiratory volume in 1 second (FEV1) from 0 to 12 hours (AUC0-12) on Day 8		7 days of treatment
Secondary	Composite Measure of Pharmacokinetics on Day 8	(PK parameters at all doses will include Cmax, AUC0-12, tmax)	7 days of treatment