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Trial Outcomes & Findings for Assessment Of The Effects Of Short and Long Term Use Of CPAP (NCT NCT00592631)

NCT ID: NCT00592631

Last Updated: 2016-02-10

Results Overview

Methacholine is an inhaled medication used to assess asthma and reactive airways. It was given at increasing concentrations (beginning with 0.0625 mg/ml and ending with 16.0 mg/ml). Each dose was followed by a lung measurement until a change of FEV1 of 20% occurs or until a maximum dose was reached, whichever came first.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

7 to 10 nights after cpap is started.

Results posted on

2016-02-10

Participant Flow

Participant milestones

Participant milestones
Measure
Continuous Positivie Airway Pressure
Adult with stable asthma and normal spirometry used CPAP with a mask pressure between 8 and 10 cm H20 for 7 to 10 nights prior to the follow-up assessment.
Sham Treatment
Adults with stable asthma and normal spirometry used SHAM with a mask pressure Mask pressure between 0 and 2 cm H20 for 7 to 10 nights prior to the follow-up assessment.
Overall Study
STARTED
16
11
Overall Study
COMPLETED
16
9
Overall Study
NOT COMPLETED
0
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Continuous Positivie Airway Pressure
Adult with stable asthma and normal spirometry used CPAP with a mask pressure between 8 and 10 cm H20 for 7 to 10 nights prior to the follow-up assessment.
Sham Treatment
Adults with stable asthma and normal spirometry used SHAM with a mask pressure Mask pressure between 0 and 2 cm H20 for 7 to 10 nights prior to the follow-up assessment.
Overall Study
Lost to Follow-up
0
2

Baseline Characteristics

Assessment Of The Effects Of Short and Long Term Use Of CPAP

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CPAP
n=16 Participants
Subjects used CPAP set at 8-10 cmH20 for 7-10 nights.
Sham
n=9 Participants
Subjects used SHAM set at 0-2 cmH20 for 7-10 nights
Total
n=25 Participants
Total of all reporting groups
Age, Continuous
27 years
STANDARD_DEVIATION 6 • n=5 Participants
32 years
STANDARD_DEVIATION 9 • n=7 Participants
29 years
STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male
Female
11 Participants
n=5 Participants
6 Participants
n=7 Participants
17 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
3 Participants
n=7 Participants
8 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 7 to 10 nights after cpap is started.

Methacholine is an inhaled medication used to assess asthma and reactive airways. It was given at increasing concentrations (beginning with 0.0625 mg/ml and ending with 16.0 mg/ml). Each dose was followed by a lung measurement until a change of FEV1 of 20% occurs or until a maximum dose was reached, whichever came first.

Outcome measures

Outcome measures
Measure
CPAP
n=16 Participants
Subjects used CPAP set at 8-10 cmH20 for 7-10 nights.
Sham
n=9 Participants
Subjects used sham set at 0-2 cmH20 for 7-10 nights
Change in Provocative Concentration of Methacholine Causing a 20% Fall in Forced Expiratory Volume in 1 Second (FEV1)
0.406 log mg/ml
Standard Error 0.066
0.003 log mg/ml
Standard Error 0.193

Adverse Events

Continuous Positive Airway Pressure

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sham

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

Robert Tepper, MD, Ph.D.

Indiana University

Phone: 317-274-9647

Results disclosure agreements

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