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Genetic Susceptibility to Ozone in Mild Asthmatic Volunteers (Glutoz)

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ClinicalTrials.gov Identifier: NCT00287365
Recruitment Status : Completed
First Posted : February 6, 2006
Results First Posted : May 15, 2017
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
Environmental Protection Agency (EPA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Mild Asthma
Intervention Drug: ozone
Enrollment 25
Recruitment Details  
Pre-assignment Details None. All subjects who successfully screened were enrolled.
Arm/Group Title Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to
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Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects

ozone: 2 hour exposure to 0.4 ppm ozone

Period Title: Overall Study
Started 25
Completed 12
Not Completed 13
Reason Not Completed
sample not acquired             13
Arm/Group Title Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to
Hide Arm/Group Description

Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects

ozone: 2 hour exposure to 0.4 ppm ozone

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
Analysis population only includes those who could produce sputum after ozone challenge. 2 of the original 25 volunteers did not produce adequate sputum
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
25
(18 to 50)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
8
  66.7%
Male
4
  33.3%
[1]
Measure Analysis Population Description: 2 subjects had insufficient sputum post exposure for analysis.
1.Primary Outcome
Title Post Ozone Change in Lung Function (FEV1) Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects
Hide Description [Not Specified]
Time Frame 6 hours post exposure
Hide Outcome Measure Data
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Mild asthmatics exposed to ozone
Arm/Group Title GSTM1 Null GSTM1 Sufficient
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GSTM1 null mild asthmatics
GSTM1 sufficient mild asthmatics
Overall Number of Participants Analyzed 4 8
Mean (Standard Error)
Unit of Measure: percentage of FEV1 predicted
85  (6) 79  (6)
2.Secondary Outcome
Title Secondary Endpoints Include Post Ozone Airway PMN Influx Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects
Hide Description [Not Specified]
Time Frame 6 hours post exposure
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title GSTM1 Null GSTM1 Sufficient
Hide Arm/Group Description:
GSTM1 null mild asthmatics
GSTM1 sufficient mild asthmatics
Overall Number of Participants Analyzed 4 8
Mean (Standard Error)
Unit of Measure: percentage of cells
4  (8) 8  (16)
3.Secondary Outcome
Title % Decrease in FVC in Asthmatics Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects
Hide Description [Not Specified]
Time Frame 6 hours post exposure
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title GSTM1 Null GSTM1 Sufficient
Hide Arm/Group Description:
GSTM1 null mild asthmatics
GSTM1 sufficient mild asthmatics
Overall Number of Participants Analyzed 4 8
Mean (Standard Error)
Unit of Measure: percentage of FVC predicted
93  (5) 85  (4)
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to
Hide Arm/Group Description

Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects

ozone: 2 hour exposure to 0.4 ppm ozone

All-Cause Mortality
Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to
Affected / at Risk (%) # Events
Total   0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to
Affected / at Risk (%) # Events
Total   2/25 (8.00%)    
Respiratory, thoracic and mediastinal disorders   
decreased FEV1   1/25 (4.00%)  1
sore throat   1/25 (4.00%)  1
Indicates events were collected by systematic assessment
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: David B. Peden, MD, MS
Organization: University of North Carolina at Chapel Hill
Phone: 919-966-0768
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00287365     History of Changes
Other Study ID Numbers: GCRC-2371
NCCAM 1PO1AT002620 ( Other Grant/Funding Number: National Center for Complementary and Alternative Medicine )
First Submitted: February 3, 2006
First Posted: February 6, 2006
Results First Submitted: February 15, 2017
Results First Posted: May 15, 2017
Last Update Posted: October 13, 2017