Overview

This trial is active, not recruiting.

Condition copd
Treatment glycopyrronium and formoterol fumarate metered-dose inhaler
Phase phase 3
Sponsor Pearl Therapeutics, Inc.
Start date November 2014
End date February 2015
Trial size 125 participants
Trial identifier NCT02268396, PT003016-00

Summary

This is an open-label, multi-center study to evaluate the accuracy, reliability and functionality of the Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) dose indicator in adult subjects with moderate to very severe COPD over a 4-week Treatment Period.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler (GFF MDI), PT003
glycopyrronium and formoterol fumarate metered-dose inhaler GFF MDI, PT003
GFF MDI administered as 2 inhalations BID

Primary Outcomes

Measure
Percentage of devices where the number of actuations as counted at the end of the study using the dose indicator reading is consistent (± 20 actuations) with the number of actuations reported by the subject.
time frame: 4 week treatment period

Secondary Outcomes

Measure
Percentage of devices where the number of actuations as counted at the end of the study using the dose indicator reading is consistent (± 20 actuations) with the number of actuations used as estimated by the change in MDI weight.
time frame: 4 week treatment period
Percentage of devices where the number of actuations as counted at the end of the study using the lab-advanced dose indicator reading is consistent (± 20 actuations) with the number of actuations used as reported by the subject.
time frame: 4 week treatment period
Percentage of devices where the dose indicator actuation count is >20 less than the subject-reported actuation count (undercount).
time frame: 4 week treatment period
Number of correct advances (±2 actuations) of the dose indicator based on subject reported use.
time frame: 4 week treatment period
Percentage of correct advances (±2 actuations) = 100 x (correct advances/total advances) based on subject reported use.
time frame: 4 week treatment period
Number of correct advances (±4 actuations) of the dose indicator based on subject reported use.
time frame: 4 week treatment period
Percentage of correct advances (±4 actuations) = 100 x (correct advances/total advances).
time frame: 4 week treatment period

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

Inclusion Criteria: - Give their signed written informed consent to participate. - Are at least 40 years of age and no older than 80 at Visit 1. - A female of non-child bearing potential or child bearing potential, has a negative serum pregnancy test, and agrees to approved contraceptive methods. - COPD Diagnosis: 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. - FEV1/FVC ratio of <0.70. - Post-bronchodilator FEV1 must be ≥ 30% and <80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations, and must also be greater than or equal to 750 mL. - Subject is willing and, in the opinion of the Investigator, able to adjust current COPD therapy as required by the protocol. Exclusion Criteria: - Pregnancy, nursing females or subjects trying to conceive. - Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study. - Current primary diagnosis of asthma. - History of ECG abnormalities. - Poorly controlled or worsening COPD prior to Screening or during the Screening Period. - Clinically significant bladder neck obstruction or urinary retention. - Male subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening. - Cancer that has not been in complete remission for at least five years. - Inadequately treated glaucoma. - History of allergic reaction or hypersensitivity to any component of the formulations used in this study.

Additional Information

Official title An Open-Label, Multi-Center, Dose Indicator Study of Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) in Adult Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Pearl Therapeutics, Inc..