24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003, Open-Label Spiriva® Respimat® as an Active Control, and Placebo

COPD Clinical Trial

Official title:

A Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects With Moderate to Very Severe COPD After 4 Weeks of Treatment With PT003, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02347072
• Other study ID #: PT003011-00
• Status: Completed
• Phase: Phase 3
• First received: January 21, 2015
• Last updated: March 16, 2016
• Start date: February 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD after 4 Weeks of Treatment with PT003, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• 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 =750 mL if FEV1 <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.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• GFF MDI (PT003)

• Placebo MDI

• Spiriva® Respimat® (Tiotropium Bromide)
Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)

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 in 1 second (FEV1) area under the curve from 0 to 24 hours (AUC0-24) on Day 29		28 days of Treatment	No
Secondary	FEV1 AUC12-24 on Day 29		28 days of treatment	No
Secondary	FEV1 AUC0-12 on Day 29		28 days of treatment	No
Secondary	Peak change from baseline in FEV1 following the evening dose on Day 29		28 days of treatment	No
Secondary	Peak change from baseline in FEV1 following the morning dose on Day 29		28 days of treatment	No
Secondary	Change from baseline in morning pre-dose trough FEV1 on Day 29		28 days of treatment	No
Secondary	Change from baseline in morning pre-dose trough FEV1 on Day 30		28 days of treatment	No
Secondary	Peak change from baseline in IC following the evening dose on Day 29		28 days of treatment	No
Secondary	Peak change from baseline in IC following the morning dose on Day 29		28 days of treatment	No