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Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation

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ClinicalTrials.gov Identifier: NCT00415493
Recruitment Status : Completed
First Posted : December 25, 2006
Results First Posted : October 26, 2012
Last Update Posted : March 6, 2017
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Stephen A. Tilles MD, Associated Scientists to Help Minimize Allergies

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Investigator);   Primary Purpose: Diagnostic
Condition Vasomotor Rhinitis
Interventions Other: Cold-dry air provocation
Other: Warm-moist air provocation
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cold-dry Air Followed by Warm-moist Air Warm-moist Air Followed by Cold-dry Air
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Cases Controls Total
Hide Arm/Group Description non-allergic rhinitis subjects normal subjects Total of all reporting groups
Overall Number of Baseline Participants 14 10 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 10 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
10
 100.0%
24
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 10 participants 24 participants
36.9  (10.5) 32.7  (14.6) 35.1  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 10 participants 24 participants
Female
10
  71.4%
7
  70.0%
17
  70.8%
Male
4
  28.6%
3
  30.0%
7
  29.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 10 participants 24 participants
14 10 24
1.Primary Outcome
Title Net Proportional Change in Nasal Airway Resistance
Hide Description 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.
Time Frame One hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cases Controls
Hide Arm/Group Description:
non-allergic rhinitis subjects
normal subjects
Overall Number of Participants Analyzed 14 10
Mean (Standard Error)
Unit of Measure: proportional change (unit-less)
0.11  (0.27) 0.04  (0.16)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cases Controls
Hide Arm/Group Description non-allergic rhinitis subjects normal subjects
All-Cause Mortality
Cases Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cases Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Cases Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Principal Investigator
Organization: ASTHMA Inc.
Phone: (510) 620-5714
Responsible Party: Stephen A. Tilles MD, Associated Scientists to Help Minimize Allergies
ClinicalTrials.gov Identifier: NCT00415493     History of Changes
Other Study ID Numbers: AI-005 NAR
First Submitted: December 21, 2006
First Posted: December 25, 2006
Results First Submitted: July 20, 2012
Results First Posted: October 26, 2012
Last Update Posted: March 6, 2017