Trial Outcomes & Findings for Genetic Susceptibility to Ozone in Mild Asthmatic Volunteers (NCT NCT00287365)

NCT ID: NCT00287365

Last Updated: 2017-10-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: 6 hours post exposure
• Results posted on: 2017-10-13

Participant Flow

None. All subjects who successfully screened were enrolled.

Participant milestones

Measure	Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects ozone: 2 hour exposure to 0.4 ppm ozone
Overall Study STARTED	25
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Measure	Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects ozone: 2 hour exposure to 0.4 ppm ozone
Overall Study sample not acquired	13

Baseline Characteristics

2 subjects had insufficient sputum post exposure for analysis.

Baseline characteristics by cohort

Measure	Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to n=12 Participants Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects ozone: 2 hour exposure to 0.4 ppm ozone
Age, Continuous	25 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants • 2 subjects had insufficient sputum post exposure for analysis.
Sex: Female, Male Male	4 Participants n=5 Participants • 2 subjects had insufficient sputum post exposure for analysis.

PRIMARY outcome

Timeframe: 6 hours post exposure

Population: Mild asthmatics exposed to ozone

Outcome measures

Measure	GSTM1 Null n=4 Participants GSTM1 null mild asthmatics	GSTM1 Sufficient n=8 Participants GSTM1 sufficient mild asthmatics
Post Ozone Change in Lung Function (FEV1) Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects	85 percentage of FEV1 predicted Standard Error 6	79 percentage of FEV1 predicted Standard Error 6

SECONDARY outcome

Timeframe: 6 hours post exposure

Outcome measures

Measure	GSTM1 Null n=4 Participants GSTM1 null mild asthmatics	GSTM1 Sufficient n=8 Participants GSTM1 sufficient mild asthmatics
Secondary Endpoints Include Post Ozone Airway PMN Influx Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects	4 percentage of cells Standard Error 8	8 percentage of cells Standard Error 16

SECONDARY outcome

Timeframe: 6 hours post exposure

Outcome measures

Measure	GSTM1 Null n=4 Participants GSTM1 null mild asthmatics	GSTM1 Sufficient n=8 Participants GSTM1 sufficient mild asthmatics
% Decrease in FVC in Asthmatics Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects	93 percentage of FVC predicted Standard Error 5	85 percentage of FVC predicted Standard Error 4

Adverse Events

Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to n=25 participants at risk Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects ozone: 2 hour exposure to 0.4 ppm ozone
Respiratory, thoracic and mediastinal disorders decreased FEV1	4.0% 1/25 • Number of events 1 • 2 weeks
Respiratory, thoracic and mediastinal disorders sore throat	4.0% 1/25 • Number of events 1 • 2 weeks

Additional Information

David B. Peden, MD, MS

University of North Carolina at Chapel Hill

Phone: 919-966-0768

Email: dpeden@med.unc.edu

Results disclosure agreements

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