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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Cold-dry Air Followed by Warm-moist Air   Warm-moist Air Followed by Cold-dry Air
STARTED   12   12 
COMPLETED   12   12 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cases non-allergic rhinitis subjects
Controls normal subjects
Total Total of all reporting groups

Baseline Measures
   Cases   Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   10   24 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 36.9  (10.5)   32.7  (14.6)   35.1  (12.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10  71.4%      7  70.0%      17  70.8% 
Male      4  28.6%      3  30.0%      7  29.2% 
Region of Enrollment 
[Units: Participants]
     
United States   14   10   24 


  Outcome Measures

1.  Primary:   Net Proportional Change in Nasal Airway Resistance   [ Time Frame: One hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: dennis.shusterman@cdph.ca.gov



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