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Trial Outcomes & Findings for Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation (NCT NCT00415493)

NCT ID: NCT00415493

Last Updated: 2017-03-06

Results Overview

Net proportional change in nasal airway resistance, pre- to post-exposure, cold air minus warm air day, calculated as a time-weighted average over the 1.0 h post-exposure. At each time point (pre-exposure, immediately post-exposure, and at 15-, 30-, 45- and 60 minutes post-exposure), nasal airway resistance (in Pa/L/sec) was measured in triplicate. The average of each of these measures was taken for each time point. The time-weighted average of these averages was then calculated for the post-exposure time points and compared with the baseline average for that individual on that testing day. The proportional change from baseline on that day was then calculated (unit-less measure). The difference between the pre-to-post change on the cold air day minus the pre-to-post change on the warm air day was then calculated (unit-less measure). The net proportional change corrects for both inter- and intra-individual variability, which in the case of nasal airway resistance is considerable.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

One hour

Results posted on

2017-03-06

Participant Flow

Participant milestones

Participant milestones
Measure
Cold-dry Air Followed by Warm-moist Air
To control for possible stimulus-order effects, half of the subjects were evaluated pre- and post-exposure to Cold-dry air followed (on a separate day) by Warm-moist air. Exposures lasted 15 minutes, with a one-hour follow-up period.
Warm-moist Air Followed by Cold-dry Air
To control for possible stimulus-order effects, half of the subjects were evaluated pre- and post-exposure to Warm-moist air followed (on a separate day) by Cold-dry air. Exposures lasted 15 minutes, with a one-hour follow-up period.
Overall Study
STARTED
12
12
Overall Study
COMPLETED
12
12
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cases
n=14 Participants
non-allergic rhinitis subjects
Controls
n=10 Participants
normal subjects
Total
n=24 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
n=5 Participants
10 Participants
n=7 Participants
24 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
36.9 years
STANDARD_DEVIATION 10.5 • n=5 Participants
32.7 years
STANDARD_DEVIATION 14.6 • n=7 Participants
35.1 years
STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
7 Participants
n=7 Participants
17 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
3 Participants
n=7 Participants
7 Participants
n=5 Participants
Region of Enrollment
United States
14 participants
n=5 Participants
10 participants
n=7 Participants
24 participants
n=5 Participants

PRIMARY outcome

Timeframe: One hour

Net proportional change in nasal airway resistance, pre- to post-exposure, cold air minus warm air day, calculated as a time-weighted average over the 1.0 h post-exposure. At each time point (pre-exposure, immediately post-exposure, and at 15-, 30-, 45- and 60 minutes post-exposure), nasal airway resistance (in Pa/L/sec) was measured in triplicate. The average of each of these measures was taken for each time point. The time-weighted average of these averages was then calculated for the post-exposure time points and compared with the baseline average for that individual on that testing day. The proportional change from baseline on that day was then calculated (unit-less measure). The difference between the pre-to-post change on the cold air day minus the pre-to-post change on the warm air day was then calculated (unit-less measure). The net proportional change corrects for both inter- and intra-individual variability, which in the case of nasal airway resistance is considerable.

Outcome measures

Outcome measures
Measure
Cases
n=14 Participants
non-allergic rhinitis subjects
Controls
n=10 Participants
normal subjects
Net Proportional Change in Nasal Airway Resistance
0.11 proportional change (unit-less)
Standard Error 0.27
0.04 proportional change (unit-less)
Standard Error 0.16

Adverse Events

Cases

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

Controls

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

Principal Investigator

ASTHMA Inc.

Phone: (510) 620-5714

Results disclosure agreements

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