Trial Outcomes & Findings for Evaluating Long Acting Beta Agonists Used to Treat Asthma Among Those With Either Arg/Arg or Gly/Gly Genotypes (NCT NCT00521222)
NCT ID: NCT00521222
Last Updated: 2023-04-21
Results Overview
Absolute change in morning peak flow at the end of the 16-week study period compared with baseline (last two weeks of run-in). Peak flow measurement is a test to measure air flowing out of the lung.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
Up to 16 weeks from baseline
Results posted on
2023-04-21
Participant Flow
90 participants enrolled (40 Arg/Arg Genotype and 50 Gly/Gly Genotype). Nine Arg/Arg participants and 14 Gly/Gly participants were not randomized due to dropout or ineligibility.
Participant milestones
| Measure |
Arg/Arg Genotype on Advair (Fluticasone With Salmeterol) HFA
Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Advair (Fluticasone With Salmeterol) HFA
Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Arg/Arg Genotype on Fluticasone HFA
Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone.
Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Fluticasone HFA
Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone.
Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
18
|
16
|
18
|
|
Overall Study
COMPLETED
|
15
|
17
|
13
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
3
|
2
|
Reasons for withdrawal
| Measure |
Arg/Arg Genotype on Advair (Fluticasone With Salmeterol) HFA
Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Advair (Fluticasone With Salmeterol) HFA
Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Arg/Arg Genotype on Fluticasone HFA
Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone.
Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Fluticasone HFA
Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone.
Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Evaluating Long Acting Beta Agonists Used to Treat Asthma Among Those With Either Arg/Arg or Gly/Gly Genotypes
Baseline characteristics by cohort
| Measure |
Arg/Arg Genotype on Advair (Fluticasone With Salmeterol) HFA
n=15 Participants
Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Drug: Fluticasone with salmeterol Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Other Name: Advair HFA
Drug: Ipratropium HFA Primary as-needed rescue medication in all treatment groups Other Name: Atrovent
Drug: Albuterol HFA Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Advair (Fluticasone With Salmeterol) HFA
n=17 Participants
Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Drug: Fluticasone with salmeterol Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Other Name: Advair HFA
Drug: Ipratropium HFA Primary as-needed rescue medication in all treatment groups Other Name: Atrovent
Drug: Albuterol HFA Secondary as-needed rescue medication in all treatment groups
|
Arg/Arg Genotype on Fluticasone HFA
n=13 Participants
Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone.
Drug: Fluticasone HFA Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Other Name: Flovent HFA
Drug: Ipratropium HFA Primary as-needed rescue medication in all treatment groups Other Name: Atrovent
Drug: Albuterol HFA Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Fluticasone HFA
n=16 Participants
Gly/Gly genotype on Fluticasone HFA
Drug: Fluticasone HFA Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Other Name: Flovent HFA
Drug: Ipratropium HFA Primary as-needed rescue medication in all treatment groups Other Name: Atrovent
Drug: Albuterol HFA Secondary as-needed rescue medication in all treatment groups
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African-American
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 16 weeks from baselineAbsolute change in morning peak flow at the end of the 16-week study period compared with baseline (last two weeks of run-in). Peak flow measurement is a test to measure air flowing out of the lung.
Outcome measures
| Measure |
Arg/Arg Genotype on Advair (Fluticasone With Salmeterol) HFA
n=15 Participants
Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Advair (Fluticasone With Salmeterol) HFA
n=17 Participants
Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Arg/Arg Genotype on Fluticasone HFA
n=13 Participants
Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone.
Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Fluticasone HFA
n=16 Participants
Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone.
Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
|---|---|---|---|---|
|
Absolute Change in Morning Peak Flow
|
-15.7 L/min
Standard Deviation 69.6
|
8.4 L/min
Standard Deviation 29.7
|
-5.6 L/min
Standard Deviation 17.9
|
-14.4 L/min
Standard Deviation 36.2
|
SECONDARY outcome
Timeframe: Up to 16 weeks from baselineChange in Forced Expiratory Volume in 1 Second (FEV1) Pre-Bronchodilator as measured by spirometry
Outcome measures
| Measure |
Arg/Arg Genotype on Advair (Fluticasone With Salmeterol) HFA
n=15 Participants
Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Advair (Fluticasone With Salmeterol) HFA
n=17 Participants
Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Arg/Arg Genotype on Fluticasone HFA
n=13 Participants
Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone.
Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Fluticasone HFA
n=16 Participants
Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone.
Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
|---|---|---|---|---|
|
Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-Bronchodilator
|
-0.03 Liter
Standard Deviation 0.20
|
-0.08 Liter
Standard Deviation 0.21
|
-0.12 Liter
Standard Deviation 0.16
|
-0.11 Liter
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Up to 16 weeks from baselineChange in Forced Expiratory Volume in 1 Second (FEV1) Post-Bronchodilator as measured by spirometry
Outcome measures
| Measure |
Arg/Arg Genotype on Advair (Fluticasone With Salmeterol) HFA
n=15 Participants
Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Advair (Fluticasone With Salmeterol) HFA
n=17 Participants
Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Arg/Arg Genotype on Fluticasone HFA
n=13 Participants
Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone.
Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Fluticasone HFA
n=16 Participants
Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone.
Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
|---|---|---|---|---|
|
Change in Forced Expiratory Volume in 1 Second (FEV1) Post-Bronchodilator
|
0.02 Liter
Standard Deviation 0.20
|
-0.07 Liter
Standard Deviation 0.19
|
-0.11 Liter
Standard Deviation 0.18
|
-0.07 Liter
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: Up to 16 weeks from baselineChange in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted Pre-Bronchodilator as measured by spirometry
Outcome measures
| Measure |
Arg/Arg Genotype on Advair (Fluticasone With Salmeterol) HFA
n=15 Participants
Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Advair (Fluticasone With Salmeterol) HFA
n=17 Participants
Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Arg/Arg Genotype on Fluticasone HFA
n=13 Participants
Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone.
Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Fluticasone HFA
n=16 Participants
Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone.
Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
|---|---|---|---|---|
|
Change in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted Pre-Bronchodilator
|
-1.0 Percent Predicted
Standard Deviation 7.6
|
-2.5 Percent Predicted
Standard Deviation 7.5
|
-3.8 Percent Predicted
Standard Deviation 5.5
|
-3.3 Percent Predicted
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Up to 16 weeks from baselineAsthma symptom score measures asthma symptoms on a scale from 0 to 3. 0 = No asthma symptoms; 1 = 1-3 asthma episodes each lasting 2 hours or less, all mild; 2= 4 or more asthma episodes that interfered with activity, play, school, or sleep for less than 2 hours; 3= 1 or more asthma episodes lasting longer than 2 hours, or resulting in shortening normal activity, or seeing a doctor, or going to a hospital. A higher score indicates a worse outcome.
Outcome measures
| Measure |
Arg/Arg Genotype on Advair (Fluticasone With Salmeterol) HFA
n=15 Participants
Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Advair (Fluticasone With Salmeterol) HFA
n=17 Participants
Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Arg/Arg Genotype on Fluticasone HFA
n=13 Participants
Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone.
Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Fluticasone HFA
n=16 Participants
Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone.
Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
|---|---|---|---|---|
|
Change in Asthma Symptom Score
|
0.3 score on a scale
Standard Deviation 3.5
|
-1.2 score on a scale
Standard Deviation 3.2
|
0.4 score on a scale
Standard Deviation 4.1
|
0.5 score on a scale
Standard Deviation 1.2
|
Adverse Events
Arg/Arg Genotype on Advair (Fluticasone With Salmeterol) HFA
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Gly/Gly Genotype on Advair (Fluticasone With Salmeterol) HFA
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arg/Arg Genotype on Fluticasone HFA
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Gly/Gly Genotype on Fluticasone HFA
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arg/Arg Genotype on Advair (Fluticasone With Salmeterol) HFA
n=15 participants at risk
Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Advair (Fluticasone With Salmeterol) HFA
n=17 participants at risk
Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Arg/Arg Genotype on Fluticasone HFA
n=13 participants at risk
Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone.
Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
Gly/Gly Genotype on Fluticasone HFA
n=16 participants at risk
Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone.
Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFA: Primary as-needed rescue medication in all treatment groups
Albuterol HFA: Secondary as-needed rescue medication in all treatment groups
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
11.8%
2/17
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/13
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/16
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Right Foot Fracture
|
6.7%
1/15
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/17
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/13
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/16
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
|
Infections and infestations
Upper Respiratory Infection
|
13.3%
2/15
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
5.9%
1/17
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/13
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
6.2%
1/16
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
5.9%
1/17
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
7.7%
1/13
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/16
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
|
General disorders
Pharyngitis
|
0.00%
0/15
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/17
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
7.7%
1/13
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/16
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
|
Gastrointestinal disorders
Gastric Reflux
|
0.00%
0/15
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/17
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
7.7%
1/13
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/16
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Wheeze
|
0.00%
0/15
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/17
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
7.7%
1/13
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/16
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
5.9%
1/17
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/13
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/16
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
|
General disorders
Motor Vehicle Accident
|
0.00%
0/15
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/17
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/13
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
6.2%
1/16
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
|
Nervous system disorders
Compressed Cervical Nerve
|
0.00%
0/15
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/17
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
0.00%
0/13
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
6.2%
1/16
Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
|
Additional Information
Marjorie Slankard, MD
Columbia University Irving Medical Center
Phone: 212-326-8410
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place