Trial Outcomes & Findings for Effect of Inhaled Steroids on Gene Expression in the Lungs - 2 (NCT NCT00826748)
NCT ID: NCT00826748
Last Updated: 2018-01-25
Results Overview
The primary study endpoint is a change in the gene expression in the airway epithelium or alveolar macrophages of healthy smokers following treatment with beclomethasone. Airway epithelium and alveolar macrophages are processed to yield high quality RNA. Complementary DNA (cDNA) is transcribed from the RNA in vitro and the product is hybridized onto gene microarray chips. The chip is then scanned and the image analyzed using the Affymetrix Microarray suite version 5 (MAS5) algorithm. Using GeneSpring software the data is normalized and differential expression is determined by fold change (up or down regulation) of the individual genes by comparing the geometric mean expression value from the airway epithelium and alveolar macrophages obtained from Day 7 and Day 14 following initiation of therapy to baseline values.
TERMINATED
PHASE4
24 participants
Analysis will be done on samples collected on Day 7 and Day 14 following initiation of therapy compared to baseline values obtained on the day prior to initiation of treatment.
2018-01-25
Participant Flow
24 subjects underwent informed consent and enrolled into the study. 2 smoker subjects screen-failed (recent illicit drug use history of myocardial infarction). These individuals were dropped from the study prior to randomization, therefore only 22 individuals were assigned into one of the three study groups.
Participant milestones
| Measure |
Treated Smokers
The treatment with inhaled beclomethasone will be administered to Treated Smokers from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. QVAR will be purchased by the Department of Genetic Medicine. The dose will be 2 puffs twice a day for 7 days.
|
Non-Treated Smokers
Non-Treated Smokers will act as control and include healthy smokers who receive no treatment.
|
Non-Smokers
Non-Smokers will act as control and include healthy non-smokers who receive no treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
12
|
|
Overall Study
COMPLETED
|
6
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
4
|
Reasons for withdrawal
| Measure |
Treated Smokers
The treatment with inhaled beclomethasone will be administered to Treated Smokers from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. QVAR will be purchased by the Department of Genetic Medicine. The dose will be 2 puffs twice a day for 7 days.
|
Non-Treated Smokers
Non-Treated Smokers will act as control and include healthy smokers who receive no treatment.
|
Non-Smokers
Non-Smokers will act as control and include healthy non-smokers who receive no treatment.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Samples Did Not pass QC
|
0
|
0
|
1
|
Baseline Characteristics
Effect of Inhaled Steroids on Gene Expression in the Lungs - 2
Baseline characteristics by cohort
| Measure |
Treated Smokers
n=6 Participants
The treatment with inhaled beclomethasone will be administered to Treated Smokers from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. QVAR will be purchased by the Department of Genetic Medicine. The dose will be 2 puffs twice a day for 7 days.
|
Non-Treated Smokers
n=4 Participants
Non-Treated Smokers will act as a control and includes healthy smokers who received no treatment.
|
Non-smokers
n=12 Participants
Non-Smokers will act as a control and includes healthy non-smokers who received no treatment.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Analysis will be done on samples collected on Day 7 and Day 14 following initiation of therapy compared to baseline values obtained on the day prior to initiation of treatment.Population: Subjects underwent bronchoscopy procedure at 7 and 14 days after baseline to collect samples including small airway epithelium and alveolar macrophages.
The primary study endpoint is a change in the gene expression in the airway epithelium or alveolar macrophages of healthy smokers following treatment with beclomethasone. Airway epithelium and alveolar macrophages are processed to yield high quality RNA. Complementary DNA (cDNA) is transcribed from the RNA in vitro and the product is hybridized onto gene microarray chips. The chip is then scanned and the image analyzed using the Affymetrix Microarray suite version 5 (MAS5) algorithm. Using GeneSpring software the data is normalized and differential expression is determined by fold change (up or down regulation) of the individual genes by comparing the geometric mean expression value from the airway epithelium and alveolar macrophages obtained from Day 7 and Day 14 following initiation of therapy to baseline values.
Outcome measures
| Measure |
Treated Smokers
n=6 Participants
The treatment with inhaled beclomethasone will be administered to Treated Smokers from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. QVAR will be purchased by the Department of Genetic Medicine. The dose will be 2 puffs twice a day for 7 days
|
Non-Treated Smokers
n=4 Participants
Non-Treated Smokers will act as control and include healthy smokers who receive no treatment.
|
Non-Smokers
n=10 Participants
Non-Smokers will act as control and include healthy non-smokers who receive no treatment. Two subjects withdrew consent prior to the Day 7 timepoint, therefore only 10 subjects have data available past Day 7.
|
|---|---|---|---|
|
Number of Participants With A Significant Change in Gene Expression in the Airway Epithelium and Alveolar Macrophages at Days 7 and 14
Small Airway Epithelium
|
0 Participants
|
NA Participants
No analysis was performed for this group since:
1. There was no effect observed in the intervention group (Treated Smokers) and
2. Not enough subjects had samples collected for all timepoints obviating a meaningful analysis.
|
NA Participants
No analysis was performed for this group since:
1. There was no effect observed in the intervention group (Treated Smokers) and
2. Not enough subjects had samples collected for all timepoints obviating a meaningful analysis
|
|
Number of Participants With A Significant Change in Gene Expression in the Airway Epithelium and Alveolar Macrophages at Days 7 and 14
Alveolar Macrophages
|
0 Participants
|
NA Participants
No analysis was performed for this group since:
1. There was no effect observed in the intervention group (Treated Smokers) and
2. Not enough subjects had samples collected for all timepoints obviating a meaningful analysis.
|
NA Participants
No analysis was performed for this group since:
1. There was no effect observed in the intervention group (Treated Smokers) and
2. Not enough subjects had samples collected for all timepoints obviating a meaningful analysis.
|
Adverse Events
Treated Smokers
Non-Treated Smokers
Non-smokers
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