Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) Dose Indicator Study in Adults With Moderate to Very Severe COPD

COPD Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268396
• Other study ID #: PT003016-00
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2014
• Last updated: July 7, 2015
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: May 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler
GFF MDI administered as 2 inhalations BID

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	Columbus	Ohio
United States	Pearl Investigative Site	Greenville	South Carolina
United States	Pearl Investigative Site	Medford	Oregon
United States	Pearl Investigative Site	Richmond	Virginia
United States	Pearl Investigative Site	Rock Hill	South Carolina
United States	Pearl Investigative Site	Spartanburg	South Carolina
United States	Pearl Investigative Site	Tampa	Florida
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	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.		4 week treatment period	No
Secondary	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.		4 week treatment period	Yes
Secondary	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.		4 week treatment period	No
Secondary	Percentage of devices where the dose indicator actuation count is >20 less than the subject-reported actuation count (undercount).		4 week treatment period	No
Secondary	Number of correct advances (±2 actuations) of the dose indicator based on subject reported use.		4 week treatment period	No
Secondary	Percentage of correct advances (±2 actuations) = 100 x (correct advances/total advances) based on subject reported use.		4 week treatment period	No
Secondary	Number of correct advances (±4 actuations) of the dose indicator based on subject reported use.		4 week treatment period	No
Secondary	Percentage of correct advances (±4 actuations) = 100 x (correct advances/total advances).		4 week treatment period	No