Trial Outcomes & Findings for PEEP as Rescue Therapy for Asthmatics With Elevated BMI (NCT NCT02696980)

NCT ID: NCT02696980

Last Updated: 2024-07-17

Results Overview

Investigators compare changes in respiratory system elastance to methacholine. Respiratory system impedance was measured at the 8-min time point and fit with the two-compartment series model of respiratory mechanics. The elastances of the central and distal compartments obtained from good quality fits of this model are reported for each of the following conditions: V2: PEP of 0 was administered during (0-4.5 min) and after (4.5-8 min) methacholine administration. V3: PEP of 0 was administered during (0-4.5 min) and PEP of 10 cmH2O after (4.5-8 min) methacholine administration. V4: This is a repeat of V2 above to test for stability of the response. V5: PEP of 10 cmH2O was administered both during (0-4.5 min) and after (4.5-8 min) methacholine administration. V1 was a baseline visit to establish physiologic parameters required for conducting Visits 2-5. There are no outcome measures for Visit 1.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: The end of the experiment (at the 8-min time point)
• Results posted on: 2024-07-17

Participant Flow

Participants were enrolled between 2016-2019. There was a minor delay to the enrollment timeline relative to the proposed starting date due to staffing changes. The uploaded protocol is an IRB approved document. Given that the study is now complete, the IRB record has been closed out and further modification of this protocol is not possible.

Participant milestones

Measure	All Patients Cross over study: Intervention: 1. Positive expiratory pressure (PEP) 10 applied for 2.5 minutes after administration of participant's PC20 dose of methacholine (dose producing a 20% fall in FEV1). 2. PEP 10 during and after for 2.5 minutes after participant's PC20 dose of methacholine 3. PEP 0 during and for 2.5 minutes after administration of participant's PC20 dose of methacholine All participants were studied in conditions 1, 2 and 3 on separate days, order of visits were randomized
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PEEP as Rescue Therapy for Asthmatics With Elevated BMI

Baseline characteristics by cohort

Measure	All Study Participants Assigned to Intervention in Cross Over Design n=18 Participants participants underwent the following studies and intervention 1\. PEP 10 after methacholine 3. PEP 10 during methacholine 3. PEP 0
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: The end of the experiment (at the 8-min time point)

Investigators compare changes in respiratory system elastance to methacholine. Respiratory system impedance was measured at the 8-min time point and fit with the two-compartment series model of respiratory mechanics. The elastances of the central and distal compartments obtained from good quality fits of this model are reported for each of the following conditions:

V2: PEP of 0 was administered during (0-4.5 min) and after (4.5-8 min) methacholine administration.

V3: PEP of 0 was administered during (0-4.5 min) and PEP of 10 cmH2O after (4.5-8 min) methacholine administration.

V4: This is a repeat of V2 above to test for stability of the response. V5: PEP of 10 cmH2O was administered both during (0-4.5 min) and after (4.5-8 min) methacholine administration.

V1 was a baseline visit to establish physiologic parameters required for conducting Visits 2-5. There are no outcome measures for Visit 1.

Outcome measures

Measure	Visit 2 n=10 Participants PEP 0 during and after methacholine	Visit 3 n=10 Participants PEP 0 during methacholine, PEP 10 cmH2O after methacholine	Visit 4 n=13 Participants PEP 0 during and after methacholine	Visit 5 n=10 Participants PEP 10 cmH2O during and after methacholine
Central and Peripheral Elastance Central Elastance	391 cmH2O/L Standard Error 86	461 cmH2O/L Standard Error 82	587 cmH2O/L Standard Error 299	334 cmH2O/L Standard Error 60
Central and Peripheral Elastance Peripheral Elastance	103 cmH2O/L Standard Error 50	82 cmH2O/L Standard Error 16	162 cmH2O/L Standard Error 33	42 cmH2O/L Standard Error 16

Adverse Events

Rescue

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

Anne Dixon, MD

University of Vermont

Phone: 802 847 2700

Email: anne.dixon@uvm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place