Trial Outcomes & Findings for The Effects of Different Long-acting Bronchodilator Medications on Asthma Patients With Different Genetic Variations (NCT NCT00706446)
NCT ID: NCT00706446
Last Updated: 2017-05-31
Results Overview
TERMINATED
NA
255 participants
1 year
2017-05-31
Participant Flow
Recruitment for the GABLE study took place from 06/01/2008 to 06/01/2010 at the Asthma Research Center at Brigham and Women's Hospital.
Participant milestones
| Measure |
1 - Tiotropium Plus ICS in the Arg/Arg Genotype
Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
|
2 - Tiotropium Plus ICS in the Arg/Gly Genotype
Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
|
3 - Tiotropium Plus ICS in the Gly/Gly Genotype
Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p
|
4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype
Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing.
|
5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype
Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing.
|
6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype
Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
57
|
44
|
26
|
54
|
45
|
|
Overall Study
COMPLETED
|
3
|
8
|
7
|
4
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
26
|
49
|
37
|
22
|
44
|
38
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant is missing information on age in the Salmeterol or Formoterol plus ICS in the Arg/Arg genotype group.
Baseline characteristics by cohort
| Measure |
1 - Tiotropium Plus ICS in the Arg/Arg Genotype
n=29 Participants
Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
|
2 - Tiotropium Plus ICS in the Arg/Gly Genotype
n=57 Participants
Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
|
3 - Tiotropium Plus ICS in the Gly/Gly Genotype
n=44 Participants
Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p
|
4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype
n=26 Participants
Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing.
|
5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype
n=54 Participants
Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing.
|
6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype
n=45 Participants
Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.3 years
STANDARD_DEVIATION 15.9 • n=29 Participants • One participant is missing information on age in the Salmeterol or Formoterol plus ICS in the Arg/Arg genotype group.
|
45.7 years
STANDARD_DEVIATION 13.2 • n=57 Participants • One participant is missing information on age in the Salmeterol or Formoterol plus ICS in the Arg/Arg genotype group.
|
46.0 years
STANDARD_DEVIATION 16.3 • n=44 Participants • One participant is missing information on age in the Salmeterol or Formoterol plus ICS in the Arg/Arg genotype group.
|
46.6 years
STANDARD_DEVIATION 14.2 • n=25 Participants • One participant is missing information on age in the Salmeterol or Formoterol plus ICS in the Arg/Arg genotype group.
|
50.3 years
STANDARD_DEVIATION 14.7 • n=54 Participants • One participant is missing information on age in the Salmeterol or Formoterol plus ICS in the Arg/Arg genotype group.
|
50.5 years
STANDARD_DEVIATION 13.6 • n=45 Participants • One participant is missing information on age in the Salmeterol or Formoterol plus ICS in the Arg/Arg genotype group.
|
47.85 years
STANDARD_DEVIATION 14.58 • n=254 Participants • One participant is missing information on age in the Salmeterol or Formoterol plus ICS in the Arg/Arg genotype group.
|
|
Sex: Female, Male
Female
|
8 Participants
n=29 Participants • One participant in the Salmeterol or Formoterol plus ICS in the Arg/Gly genotype group is missing sex information.
|
14 Participants
n=57 Participants • One participant in the Salmeterol or Formoterol plus ICS in the Arg/Gly genotype group is missing sex information.
|
14 Participants
n=44 Participants • One participant in the Salmeterol or Formoterol plus ICS in the Arg/Gly genotype group is missing sex information.
|
8 Participants
n=26 Participants • One participant in the Salmeterol or Formoterol plus ICS in the Arg/Gly genotype group is missing sex information.
|
21 Participants
n=53 Participants • One participant in the Salmeterol or Formoterol plus ICS in the Arg/Gly genotype group is missing sex information.
|
11 Participants
n=45 Participants • One participant in the Salmeterol or Formoterol plus ICS in the Arg/Gly genotype group is missing sex information.
|
76 Participants
n=254 Participants • One participant in the Salmeterol or Formoterol plus ICS in the Arg/Gly genotype group is missing sex information.
|
|
Sex: Female, Male
Male
|
21 Participants
n=29 Participants • One participant in the Salmeterol or Formoterol plus ICS in the Arg/Gly genotype group is missing sex information.
|
43 Participants
n=57 Participants • One participant in the Salmeterol or Formoterol plus ICS in the Arg/Gly genotype group is missing sex information.
|
30 Participants
n=44 Participants • One participant in the Salmeterol or Formoterol plus ICS in the Arg/Gly genotype group is missing sex information.
|
18 Participants
n=26 Participants • One participant in the Salmeterol or Formoterol plus ICS in the Arg/Gly genotype group is missing sex information.
|
32 Participants
n=53 Participants • One participant in the Salmeterol or Formoterol plus ICS in the Arg/Gly genotype group is missing sex information.
|
34 Participants
n=45 Participants • One participant in the Salmeterol or Formoterol plus ICS in the Arg/Gly genotype group is missing sex information.
|
178 Participants
n=254 Participants • One participant in the Salmeterol or Formoterol plus ICS in the Arg/Gly genotype group is missing sex information.
|
|
Region of Enrollment
United States
|
29 Participants
n=29 Participants
|
57 Participants
n=57 Participants
|
44 Participants
n=44 Participants
|
26 Participants
n=26 Participants
|
54 Participants
n=54 Participants
|
45 Participants
n=45 Participants
|
255 Participants
n=255 Participants
|
PRIMARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
1 - Tiotropium Plus ICS in the Arg/Arg Genotype
n=29 Participants
Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
|
2 - Tiotropium Plus ICS in the Arg/Gly Genotype
n=57 Participants
Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
|
3 - Tiotropium Plus ICS in the Gly/Gly Genotype
n=44 Participants
Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype
tiotropium bromide: tiotropium bromide one inhalation a day for one year
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p
|
4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype
n=26 Participants
Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing.
|
5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype
n=54 Participants
Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing.
|
6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype
n=45 Participants
Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype
Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR
Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.
Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,
OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Asthma Exacerbation
|
3 Participants
|
15 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Data was not collected for secondary outcomes due to study termination
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data was not collected for secondary outcomes due to study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data was not collected for secondary outcomes due to study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data was not collected for secondary outcomes due to study termination.
Outcome measures
Outcome data not reported
Adverse Events
1 - Tio/ICS in the Arg/Arg Genotype
2 - Tio/ICS in the Arg/Gly Genotype
3 - Tio/ICS in the Gly/Gly Genotype
4 - LABA/ICS in the Arg/Arg Genotype
5 - LABA/ICS in the Arg/Gly Genotype
6 - LABA/ICS in the Gly/Gly Genotype
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