Trial Outcomes & Findings for Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) Dose Indicator Study in Adults With Moderate to Very Severe COPD (NCT NCT02268396)

NCT ID: NCT02268396

Last Updated: 2016-12-23

Results Overview

Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit: ITT Population

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

138 participants

Primary outcome timeframe

Over the life of the canister/120 puffs - up to 4 weeks

Results posted on

2016-12-23

Participant Flow

Conducted at 10 study sites in the United states from November 2014 - January 2015. The entire study period was scheduled to take approximately 6 weeks for each individual subject. The study was anticipated to run for approximately 6 months.

Study was an open-label, multi center study to evaluate the accuracy, reliability, and functionality of GFF MDI dose indicator in adult subjects with moderate to very severe COPD over a 4-week treatment period.

Participant milestones

Participant milestones
Measure	GFF MDI (PT003) GFF MDI 14.4/9.6 μg
Overall Study STARTED	138
Overall Study COMPLETED	126
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	GFF MDI (PT003) GFF MDI 14.4/9.6 μg
Overall Study Adverse Event	3
Overall Study Administrative	2
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	2
Overall Study Protocol-Specified Criteria	2
Overall Study 2 Subjects no Day 29 Assessment	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GFF MDI (PT003) n=138 Participants GFF MDI 14.4/9.6 μg
Age, Continuous	62.1 Years STANDARD_DEVIATION 8.3 • n=5 Participants
Gender Female	68 Participants n=5 Participants
Gender Male	70 Participants n=5 Participants

PRIMARY outcome

Timeframe: Over the life of the canister/120 puffs - up to 4 weeks

Population: ITT Population

Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit: ITT Population

Outcome measures

Outcome measures
Measure	GFF MDI (PT003) n=137 Participants GFF MDI 14.4/9.6 μg
Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count	96.4 Percentage 18.9 • Interval 0.0 to 130.0

SECONDARY outcome

Timeframe: Over the life of the canister/120 puffs - up to 4 weeks

Population: ITT Population

Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight

Outcome measures

Outcome measures
Measure	GFF MDI (PT003) n=137 Participants GFF MDI 14.4/9.6 μg
Percentage of Devices in Agreement Between eCRF-Based Dose Indicator Actuation Count and Weight-Based Actuation Count at the Last Available Visit	86.9 Percentage of Devices 19.0 • Interval 18.0 to 130.0

SECONDARY outcome

Timeframe: Over the life of the canister/120 puffs - up to 4 weeks

Population: ITT Population

Percentage of devices whose number of actuations counted at the end of the study, using the lab-advanced dose indicator reading, was consistent (±20 actuations) with the number of actuations used as reported by the subject

Outcome measures

Outcome measures
Measure	GFF MDI (PT003) n=132 Participants GFF MDI 14.4/9.6 μg
Percentage of Devices in Agreement Between Laboratory-Advanced Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit	96.2 Percentage of devices 19.0 • Interval 0.0 to 130.0

SECONDARY outcome

Timeframe: Over the life of the canister/120 puffs - up to 4 weeks

Population: ITT Population

Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight

Outcome measures

Outcome measures
Measure	GFF MDI (PT003) n=132 Participants GFF MDI 14.4/9.6 μg
Percentage of Devices in Agreement Between Laboratory-advanced Does Indicator Actuation and Weight-based Actuation Count at Last Available Visit.	75.0 Percentage 19.0 • Interval 17.0 to 171.0

SECONDARY outcome

Timeframe: Over the life of the canister/120 puffs - up to 4 weeks

Population: ITT Population

Percentage of devices where the dose indicator actuation count is \>20 less than the subject-reported actuation count (undercount)

Outcome measures

Outcome measures
Measure	GFF MDI (PT003) n=132 Participants GFF MDI 14.4/9.6 μg
Percentage of Devices Where the Dose Indicator Actuation Count is >20 Less Than the Subject-reported Actuation Count (Undercount)	2.9 Percentage 2.9 • Interval 17.0 to 171.0

SECONDARY outcome

Timeframe: Over the life of the canister/120 puffs - up to 4 weeks

Population: ITT Population

Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count

Outcome measures

Outcome measures
Measure	GFF MDI (PT003) n=132 Participants GFF MDI 14.4/9.6 μg
Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count Correct within ±2 actuations	87.3 Percentage of correct advances Interval 17.0 to 171.0
Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count Correct within ±4 actuations	93.2 Percentage of correct advances

Adverse Events

GFF MDI (PT003)

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GFF MDI (PT003) n=138 participants at risk GFF MDI 14.4/9.6 μg
Respiratory, thoracic and mediastinal disorders COPD	1.4% 2/138 • Number of events 2 • AEs occurring between when signed consent and randomized reported as SAEs up to 14 days following last dose of study drug. AEs occurring at time of and following first study drug administration were reported and followed until stabilized/resolved. Safety population included all participants who received at least one dose of investigational drug and had safety data available (Note: A subject who used the GFF MDI, but took less than 1 full dose of treatment qualified for this population.)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Neoplasm	0.72% 1/138 • Number of events 1 • AEs occurring between when signed consent and randomized reported as SAEs up to 14 days following last dose of study drug. AEs occurring at time of and following first study drug administration were reported and followed until stabilized/resolved. Safety population included all participants who received at least one dose of investigational drug and had safety data available (Note: A subject who used the GFF MDI, but took less than 1 full dose of treatment qualified for this population.)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Pain	0.72% 1/138 • Number of events 1 • AEs occurring between when signed consent and randomized reported as SAEs up to 14 days following last dose of study drug. AEs occurring at time of and following first study drug administration were reported and followed until stabilized/resolved. Safety population included all participants who received at least one dose of investigational drug and had safety data available (Note: A subject who used the GFF MDI, but took less than 1 full dose of treatment qualified for this population.)

Other adverse events

Other adverse events
Measure	GFF MDI (PT003) n=138 participants at risk GFF MDI 14.4/9.6 μg
Respiratory, thoracic and mediastinal disorders COPD	7.2% 10/138 • Number of events 11 • AEs occurring between when signed consent and randomized reported as SAEs up to 14 days following last dose of study drug. AEs occurring at time of and following first study drug administration were reported and followed until stabilized/resolved. Safety population included all participants who received at least one dose of investigational drug and had safety data available (Note: A subject who used the GFF MDI, but took less than 1 full dose of treatment qualified for this population.)

Additional Information

Colin Reisner, MD, FCCP, FAAAAI

Pearl Therapeutics Inc

Phone: 973-975-0320

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent its opinions, or the opinions of the publication committee, if these differ with the proposed publication.
Publication restrictions are in place

Restriction type: OTHER