Clinical trial NCT02643082: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COPD
Lead sponsor: Pearl Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-30
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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 β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.

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

Primary outcomes:
measure: Specific Airway Volume (siVaw)
timeFrame: Day 15
measure: Specific Airway Resistance (siRaw)
timeFrame: Day 15
Secondary outcomes:
measure: Airway Resistance (iRaw)
timeFrame: Day 15
measure: Airway Volume (iVaw)
timeFrame: Day 15
measure: Change From Baseline in FEV1 (L) at Day 15
timeFrame: Baseline and Day 15
measure: Change From Baseline in FRC (L) at Day 15
timeFrame: Baseline and Day 15
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Research Site
Study officials:
affiliation: Pearl Therapeutics
name: Chad Orevillo
role: STUDY_DIRECTOR
References:
citation: De Backer W, De Backer J, Vos W, Verlinden I, Van Holsbeke C, Clukers J, Hajian B, Siddiqui S, Jenkins M, Reisner C, Martin UJ. A randomized study using functional respiratory imaging to characterize bronchodilator effects of glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler using co-suspension delivery technology in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2018 Aug 30;13:2673-2684. doi: 10.2147/COPD.S171707. eCollection 2018.