Trial Outcomes & Findings for Health Effects of Diesel Exhaust in Asthmatic Patients: A Real-world Study in a London Street (NCT NCT00127062)
NCT ID: NCT00127062
Last Updated: 2019-11-05
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
baseline, 24 hours after
Results posted on
2019-11-05
Participant Flow
Healthy volunteers were not recruited. Only asthma patients.
Participant milestones
| Measure |
Mild Asthma
Asthma patients with mild asthma
|
Moderate Asthma
Asthma patients with moderate asthma
|
|---|---|---|
|
First intervention_Oxford Street
STARTED
|
31
|
29
|
|
First intervention_Oxford Street
COMPLETED
|
31
|
29
|
|
First intervention_Oxford Street
NOT COMPLETED
|
0
|
0
|
|
Second intervention_Hyde Park
STARTED
|
31
|
29
|
|
Second intervention_Hyde Park
COMPLETED
|
31
|
29
|
|
Second intervention_Hyde Park
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Mild Asthma
n=31 Participants
Asthma patients with mild asthma
|
Moderate Asthma
n=29 Participants
Asthma patients with moderate asthma
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 years
n=31 Participants
|
34 years
n=29 Participants
|
32 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=31 Participants
|
15 Participants
n=29 Participants
|
29 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=31 Participants
|
14 Participants
n=29 Participants
|
31 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
31 participants
n=31 Participants
|
29 participants
n=29 Participants
|
60 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: baseline, 24 hours afterOutcome measures
| Measure |
Mild Asthma Hyde Park
n=31 Participants
Mild asthma patients walking on Hyde park
|
Mild Asthma Oxford Street
n=31 Participants
Mild asthma patients walking on Oxford Street
|
Moderate Asthma Hyde Park
n=29 Participants
Moderate asthma patients walking on Hyde park
|
Moderate Asthma Oxford Street
n=29 Participants
Moderate asthma patients walking on Oxford Street
|
|---|---|---|---|---|
|
Spirometry, Percentage Change in FEV1 From Baseline
|
-1.0 percentage change in FEV1 from baseline
Interval -3.0 to 0.6
|
-4.8 percentage change in FEV1 from baseline
Interval -6.8 to -2.8
|
-2.2 percentage change in FEV1 from baseline
Interval -4.0 to -1.0
|
-7.4 percentage change in FEV1 from baseline
Interval -9.5 to -5.5
|
Adverse Events
Mild asthma_Oxford Street
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mild asthma_Hyde Park
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate asthma_Oxford Street
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate asthma_Hyde Park
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place