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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

255 participants

Primary outcome timeframe

1 year

Results posted on

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

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

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 year

Outcome measures

Outcome 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 year

Population: Data was not collected for secondary outcomes due to study termination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Data was not collected for secondary outcomes due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Data was not collected for secondary outcomes due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: 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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

2 - Tio/ICS in the Arg/Gly Genotype

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

3 - Tio/ICS in the Gly/Gly Genotype

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

4 - LABA/ICS in the Arg/Arg Genotype

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

5 - LABA/ICS in the Arg/Gly Genotype

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

6 - LABA/ICS in the Gly/Gly Genotype

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

Dr. Elliot Israel

Brigham and Women's Hospital

Phone: 6177328201

Results disclosure agreements

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