Clinical trial NCT02268396: Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) Dose Indicator Study in Adults With Moderate to Very Severe COPD
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COPD
Lead sponsor: Pearl Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 138
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count
timeFrame: Over the life of the canister/120 puffs - up to 4 weeks
Secondary outcomes:
measure: Percentage of Devices in Agreement Between eCRF-Based Dose Indicator Actuation Count and Weight-Based Actuation Count at the Last Available Visit
timeFrame: Over the life of the canister/120 puffs - up to 4 weeks
measure: Percentage of Devices in Agreement Between Laboratory-Advanced Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit
timeFrame: Over the life of the canister/120 puffs - up to 4 weeks
measure: Percentage of Devices in Agreement Between Laboratory-advanced Does Indicator Actuation and Weight-based Actuation Count at Last Available Visit.
timeFrame: Over the life of the canister/120 puffs - up to 4 weeks
measure: Percentage of Devices Where the Dose Indicator Actuation Count is >20 Less Than the Subject-reported Actuation Count (Undercount)
timeFrame: Over the life of the canister/120 puffs - up to 4 weeks
measure: Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count
timeFrame: Over the life of the canister/120 puffs - up to 4 weeks
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Pearl Investigative Site
state: Florida
city: Tampa
country: United States
facility: Pearl Investigative Site
state: Florida
city: Winter Park
country: United States
facility: Pearl Investigative Site
state: Florida
city: Charlotte
country: United States
facility: Pearl Investigative Site
state: North Carolina
city: Columbus
country: United States
facility: Pearl Investigative Site
state: Ohio
city: Medford
country: United States
facility: Pearl Investigative Site
state: Oregon
city: Greenville
country: United States
facility: Pearl Investigative Site
state: South Carolina
city: Rock Hill
country: United States
facility: Pearl Investigative Site
state: South Carolina
city: Spartanburg
country: United States
facility: Pearl Investigative Site
state: South Carolina
city: Richmond
country: United States
facility: Pearl Investigative Site
state: Virginia
Study officials:
affiliation: Pearl Therapeutics
name: Colin Reisner, MD
role: STUDY_DIRECTOR
References:
citation: Pudi K, Feldman G, Fakih F, Mack P, Maes A, Siddiqui S, St Rose E, Reisner C. An Open-Label Study Evaluating the Performance of the Dose Indicator in a Metered Dose Inhaler Delivering Glycopyrrolate and Formoterol Fumarate in Patients with Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease. J Aerosol Med Pulm Drug Deliv. 2019 Feb;32(1):40-46. doi: 10.1089/jamp.2018.1466. Epub 2018 Nov 1.