Trial Outcomes & Findings for How Different Beta-2 Receptor Genotypes Affect an Asthmatic's Response to Regular Salmeterol Treatment (NCT NCT00595361)

NCT ID: NCT00595361

Last Updated: 2017-06-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 2 weeks after exercise challenge
• Results posted on: 2017-06-08

Participant Flow

Participant milestones

Measure	Arg/Arg Arg/Arg subjects on 2 week salmeterol treatment salmeterol: salmeterol 50 micrograms twice daily for 2 weeks	Gly/Gly Gly/Gly subjects on 2 week salmeterol treatment salmeterol: salmeterol 50 micrograms twice daily for 2 weeks
Overall Study STARTED	12	18
Overall Study COMPLETED	12	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

How Different Beta-2 Receptor Genotypes Affect an Asthmatic's Response to Regular Salmeterol Treatment

Baseline characteristics by cohort

Measure	Arg/Arg n=12 Participants Arg/Arg subjects on 2 week salmeterol treatment salmeterol: salmeterol 50 micrograms twice daily for 2 weeks	Gly/Gly n=14 Participants Gly/Gly subjects on 2 week salmeterol treatment salmeterol: salmeterol 50 micrograms twice daily for 2 weeks	Total n=26 Participants Total of all reporting groups
Age, Continuous	25.8 years STANDARD_DEVIATION 2.4 • n=5 Participants	27.2 years STANDARD_DEVIATION 1.4 • n=7 Participants	26.6 years STANDARD_DEVIATION 1.3 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	14 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks after exercise challenge

Outcome measures

Measure	Arg/Arg n=12 Participants Arg/Arg subjects on 2 week salmeterol treatment salmeterol: salmeterol 50 micrograms twice daily for 2 weeks	Gly/Gly n=14 Participants Gly/Gly subjects on 2 week salmeterol treatment salmeterol: salmeterol 50 micrograms twice daily for 2 weeks
Comparison of the Maximum Percent Fall in FEV1 After Exercise Challenge at the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Patients	12.6 % fall FEV1 Standard Deviation 4.5	16.5 % fall FEV1 Standard Deviation 2.9

SECONDARY outcome

Timeframe: 2 weeks from pre-salmeterol baseline

Outcome measures

Measure	Arg/Arg n=12 Participants Arg/Arg subjects on 2 week salmeterol treatment salmeterol: salmeterol 50 micrograms twice daily for 2 weeks	Gly/Gly n=14 Participants Gly/Gly subjects on 2 week salmeterol treatment salmeterol: salmeterol 50 micrograms twice daily for 2 weeks
Comparison of the Maximum Percent Fall in FEV1 From Pre-salmeterol Baseline to the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Patients	5.9 % fall FEV1 Standard Deviation 19.9	4.3 % fall FEV1 Standard Deviation 10.6

SECONDARY outcome

Timeframe: 2 weeks after 1st dose of Salmeterol

Outcome measures

Measure	Arg/Arg n=12 Participants Arg/Arg subjects on 2 week salmeterol treatment salmeterol: salmeterol 50 micrograms twice daily for 2 weeks	Gly/Gly n=14 Participants Gly/Gly subjects on 2 week salmeterol treatment salmeterol: salmeterol 50 micrograms twice daily for 2 weeks
Comparison of the Maximum Percent Fall in FEV1 After 1st Dose of Salmeterol to the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Subjects	-12.6 % fall FEV1 Standard Deviation 17.1	-16.5 % fall FEV1 Standard Deviation 10.9

Adverse Events

Arg/Arg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Gly/Gly

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

Elliot Israel, MD

Brigham and Women's Hopsital

Phone: 617-732-8110

Email: eisrael@partners.org

Results disclosure agreements

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