Trial Outcomes & Findings for Peak Inspiratory Flow and Dry Powder Inhaler Performance in COPD (NCT NCT04606394)

Results Overview

Outcome = the number of subject test days (2 test days per subject) meeting responder criteria defined as: DPI Responder - a positive (\>50 ml) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (\<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Partial Responder a positive (\>50 ml) peak FEV1 response 2 hours after Trelegy® Ellipta DPI with a positive (\>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Failure - a negative (\<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a positive (\>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) Irreversible - a negative (\<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (\<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

2 weeks

Results posted on

2023-05-08

Participant Flow

Severe/very severe COPD patients in stable condition stratified to insure that at least 12 of 30 subjects had a suboptimal peak inspiratory flow (PIF \<60L/min)

Enrollment, run-in on current maintenance therapy followed by testing, conversion of maintenance therapy to Trelegy Ellipta therapy for 2 weeks followed by testing

Participant milestones

Participant milestones
Measure	Trelegy Ellipta Open Label Treatment All subjects receive Trelegy and Ventolin for 2 weeks Trelegy Ellipta 100/62.5/25Mcg Inh 30D: Administration of Trelegy in all patients Ventolin 90Mcg/Actuation Inhalation Aerosol: 2 hours after the administration of Trelegy, administer Ventolin in all patients
Overall Study STARTED	45
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Trelegy Ellipta Open Label Treatment All subjects receive Trelegy and Ventolin for 2 weeks Trelegy Ellipta 100/62.5/25Mcg Inh 30D: Administration of Trelegy in all patients Ventolin 90Mcg/Actuation Inhalation Aerosol: 2 hours after the administration of Trelegy, administer Ventolin in all patients
Overall Study Withdrawal by Subject	3
Overall Study Exclusion criteria screen failure	12

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Treatment n=30 Participants All subjects receive Trelegy and Ventolin for 2 weeks Trelegy Ellipta 100/62.5/25Mcg Inh 30D: Administration of Trelegy in all patients Ventolin 90Mcg/Actuation Inhalation Aerosol: 2 hours after the administration of Trelegy, administer Ventolin in all patients
Age, Continuous	66 years STANDARD_DEVIATION 7 • n=30 Participants
Sex: Female, Male Female	13 Participants n=30 Participants
Sex: Female, Male Male	17 Participants n=30 Participants
Using triple therapy at baseline	18 Participants n=30 Participants
CAT score ≥10	30 Participants n=30 Participants
CAT score ≥15	28 Participants n=30 Participants
History of 2 moderate/1 severe exacerbation	9 Participants n=30 Participants
History of severe exacearbtion	8 Participants n=30 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Number of subject test days (2 per subject) with DPI Failure based on baseline PIF \<60 L/min or \>60 L/min

Outcome = the number of subject test days (2 test days per subject) meeting responder criteria defined as: DPI Responder - a positive (\>50 ml) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (\<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Partial Responder a positive (\>50 ml) peak FEV1 response 2 hours after Trelegy® Ellipta DPI with a positive (\>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Failure - a negative (\<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a positive (\>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) Irreversible - a negative (\<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (\<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy)

Outcome measures

Outcome measures
Measure	Suboptimal PIF n=24 Subjet test days Subject with PIF \< 60 L/min at baseline	Normal PIF n=36 Subjet test days Subjects with PIF \> 60 L/min at baseline	Instructed PIF Pif measured with maximal PIF instrucitons only	Encouraged PIF Pif measured while instructed and encouraged for maximal effort	Spiro PIF PIF measured with maximal inspiratory effort/flow loop during spirometry
DPI Responder Analysis in Patients With Suboptimal PIF (<60 L/Min)	2 Number of subject test days	1 Number of subject test days	—	—	—

SECONDARY outcome

Timeframe: 2 weeks

Population: Number of subject test days (2 per subject) with DPI Failure based on baseline PIF \<45 L/min or \>45 L/min

Outcome = the number of subject test days (2 test days per subject) meeting responder criteria defined as: DPI Responder - a positive (\>50 ml) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (\<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Partial Responder a positive (\>50 ml) peak FEV1 response 2 hours after Trelegy® Ellipta DPI with a positive (\>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Failure - a negative (\<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a positive (\>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) Irreversible - a negative (\<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (\<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy)

Outcome measures

Outcome measures
Measure	Suboptimal PIF n=12 Number of sub ject test days Subject with PIF \< 60 L/min at baseline	Normal PIF n=48 Number of sub ject test days Subjects with PIF \> 60 L/min at baseline	Instructed PIF Pif measured with maximal PIF instrucitons only	Encouraged PIF Pif measured while instructed and encouraged for maximal effort	Spiro PIF PIF measured with maximal inspiratory effort/flow loop during spirometry
DPI Responder Analysis in Patients With Reduced PIF (<45 L/Min)	2 Number of subject test days	1 Number of subject test days	—	—	—

SECONDARY outcome

Timeframe: Baseline on day of testing

Population: All subjects

PIF value (L/min) based on different PIF measurement techniques

Outcome measures

Outcome measures
Measure	Suboptimal PIF n=30 Participants Subject with PIF \< 60 L/min at baseline	Normal PIF n=30 Participants Subjects with PIF \> 60 L/min at baseline	Instructed PIF n=30 Participants Pif measured with maximal PIF instrucitons only	Encouraged PIF n=30 Participants Pif measured while instructed and encouraged for maximal effort	Spiro PIF n=30 Participants PIF measured with maximal inspiratory effort/flow loop during spirometry
PIF Measurement Techniques	52 L/min Standard Deviation 17	53 L/min Standard Deviation 25	70 L/min Standard Deviation 18	74 L/min Standard Deviation 18	137 L/min Standard Deviation 67

Adverse Events

Open Label Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gary T Ferguson, M.D.

PRISM

Phone: 248-514-6063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place