Trial Outcomes & Findings for Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma (NCT NCT03364608)

Last Updated: 2019-07-24

Results Overview

Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-6 (Area under the curve from 0 to 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose) normalized for length of follow up.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

86 participants

Primary outcome timeframe

Over 6 hours post dose on Day 1

Results posted on

2019-07-24

Participant Flow

This study was conducted at 10 sites in the United States, from December 2017 to March 2018. The study was anticipated to run for at least 23 days but not to exceed 68 days.

Subjects were randomized into one of 10 treatment sequences. Each sequence comprised all 5 treatments included in this study (ie, AS MDI 90 μg, AS MDI 180 μg, Placebo MDI, Proventil 90 μg, and Proventil 180 μg) in a randomized order

Participant milestones

Participant milestones
Measure	Subjects ITT Analysis set
Overall Study STARTED	86
Overall Study Placebo MDI	82
Overall Study AS MDI 90 µg	81
Overall Study AS MDI 180 µg	81
Overall Study Proventil 90 µg	82
Overall Study Proventil 180 µg	79
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Subjects ITT Analysis set
Overall Study Withdrawal by Subject	4
Overall Study Protocol Violation	2
Overall Study Lost to Follow-up	2

Baseline Characteristics

Safety Set

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=86 Participants Safety Set
Age, Continuous	42.7 Years STANDARD_DEVIATION 13.4 • n=5 Participants • Safety Set
Sex: Female, Male Female	47 Participants n=5 Participants • Safety Set
Sex: Female, Male Male	39 Participants n=5 Participants • Safety Set
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants • Safety Set
Ethnicity (NIH/OMB) Not Hispanic or Latino	72 Participants n=5 Participants • Safety Set
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Safety Set
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • Safety Set
Race (NIH/OMB) Asian	1 Participants n=5 Participants • Safety Set
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Safety Set
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants • Safety Set
Race (NIH/OMB) White	62 Participants n=5 Participants • Safety Set
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • Safety Set
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants • Safety Set

PRIMARY outcome

Timeframe: Over 6 hours post dose on Day 1

Population: mITT Population

Outcome measures

Outcome measures
Measure	AS MDI 180 µg n=79 Participants (2 actuations of 90 µg/actuation)	AS MDI 90 µg n=79 Participants (2 actuations of 45 µg/actuation)	Proventil 180 µg n=77 Participants (2 actuations of 90 µg/actuation)	Proventil 90 µg n=78 Participants (1 actuation of 90 µg/actuation)	Placebo MDI n=78 Participants (2 actuations)
Change From Baseline in FEV1 AUC0-6	0.266 Liters Interval 0.219 to 0.313	0.203 Liters Interval 0.156 to 0.251	0.282 Liters Interval 0.234 to 0.329	0.240 Liters Interval 0.193 to 0.288	0.070 Liters Interval 0.022 to 0.117

SECONDARY outcome

Timeframe: Over 4 hours post dose on Day 1

Population: mITT Population

Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-4 (Area under the curve from 0 to 4 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up.

Outcome measures

Outcome measures
Measure	AS MDI 180 µg n=79 Participants (2 actuations of 90 µg/actuation)	AS MDI 90 µg n=79 Participants (2 actuations of 45 µg/actuation)	Proventil 180 µg n=77 Participants (2 actuations of 90 µg/actuation)	Proventil 90 µg n=78 Participants (1 actuation of 90 µg/actuation)	Placebo MDI n=78 Participants (2 actuations)
Change From Baseline in FEV1 AUC0-4	0.331 Liters Interval 0.28 to 0.381	0.263 Liters Interval 0.213 to 0.313	0.349 Liters Interval 0.299 to 0.4	0.297 Liters Interval 0.247 to 0.348	0.080 Liters Interval 0.03 to 0.131

SECONDARY outcome

Timeframe: Over 6 hours post dose on Day 1

Population: mITT Population

Peak Change from baseline in FEV1 (Forced expiratory volume in 1 second)