Trial Outcomes & Findings for Body Composition Changes With Albuterol and Caffeine Versus Placebo in Adolescents (NCT NCT02740660)

NCT ID: NCT02740660

Last Updated: 2019-10-08

Results Overview

DXA Scan of obese adolescents

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: Baseline, Week 8
• Results posted on: 2019-10-08

Participant Flow

Participant milestones

Measure	Caffeine 100mg / Albuterol 4mg One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. Caffeine 100mg / Albuterol 4mg Family weight management counseling	Placebo One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. Placebo Family weight management counseling
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Body Composition Changes With Albuterol and Caffeine Versus Placebo in Adolescents

Baseline characteristics by cohort

Measure	Caffeine 100mg / Albuterol 4mg n=6 Participants One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. Caffeine 100mg / Albuterol 4mg Family weight management counseling	Placebo n=6 Participants One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. Placebo Family weight management counseling	Total n=12 Participants Total of all reporting groups
Age, Continuous	14 years STANDARD_DEVIATION 1.5 • n=5 Participants	15 years STANDARD_DEVIATION 1.9 • n=7 Participants	14 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

DXA Scan of obese adolescents

Outcome measures

Measure	Caffeine 100mg / Albuterol 4mg n=6 Participants One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. Caffeine 100mg / Albuterol 4mg Family weight management counseling	Placebo n=6 Participants One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. Placebo Family weight management counseling
Change in Fat Mass With Caffeine/Albuterol	0.97 kg Standard Deviation 1.11	-0.21 kg Standard Deviation 1.41

PRIMARY outcome

Timeframe: Baseline, Week 8

DXA Scan of obese adolescents

Outcome measures

Measure	Caffeine 100mg / Albuterol 4mg n=6 Participants One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. Caffeine 100mg / Albuterol 4mg Family weight management counseling	Placebo n=6 Participants One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. Placebo Family weight management counseling
Change in Lean Mass With Caffeine/Albuterol	1.34 kg Standard Deviation 1.22	0.88 kg Standard Deviation 1.16

PRIMARY outcome

Timeframe: Baseline, Week 8

Outcome measures

Measure	Caffeine 100mg / Albuterol 4mg n=6 Participants One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. Caffeine 100mg / Albuterol 4mg Family weight management counseling	Placebo n=6 Participants One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. Placebo Family weight management counseling
Change in Weight With Caffeine/Albuterol	2.57 kg Standard Deviation 1.92	1.05 kg Standard Deviation 2.19

SECONDARY outcome

Timeframe: Week 2, Week 4, Week 6, Week 8

Outcome measures

Measure	Caffeine 100mg / Albuterol 4mg n=6 Participants One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. Caffeine 100mg / Albuterol 4mg Family weight management counseling	Placebo n=6 Participants One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. Placebo Family weight management counseling
Number of Participants With Adverse Events	5 Participants	2 Participants

Adverse Events

Caffeine 100mg / Albuterol 4mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Caffeine 100mg / Albuterol 4mg n=6 participants at risk One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. Caffeine 100mg / Albuterol 4mg Family weight management counseling	Placebo n=6 participants at risk One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks. Placebo Family weight management counseling
Nervous system disorders Headache	16.7% 1/6 • Number of events 1 • 8 weeks Adverse events were collected at Week 2, 4, 6, 8	16.7% 1/6 • Number of events 1 • 8 weeks Adverse events were collected at Week 2, 4, 6, 8
Nervous system disorders Drowsiness	0.00% 0/6 • 8 weeks Adverse events were collected at Week 2, 4, 6, 8	16.7% 1/6 • Number of events 1 • 8 weeks Adverse events were collected at Week 2, 4, 6, 8
Cardiac disorders Palpitations	16.7% 1/6 • Number of events 1 • 8 weeks Adverse events were collected at Week 2, 4, 6, 8	0.00% 0/6 • 8 weeks Adverse events were collected at Week 2, 4, 6, 8
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	16.7% 1/6 • Number of events 1 • 8 weeks Adverse events were collected at Week 2, 4, 6, 8	0.00% 0/6 • 8 weeks Adverse events were collected at Week 2, 4, 6, 8
Nervous system disorders Tremor	16.7% 1/6 • Number of events 1 • 8 weeks Adverse events were collected at Week 2, 4, 6, 8	0.00% 0/6 • 8 weeks Adverse events were collected at Week 2, 4, 6, 8
General disorders Toothache	16.7% 1/6 • Number of events 1 • 8 weeks Adverse events were collected at Week 2, 4, 6, 8	0.00% 0/6 • 8 weeks Adverse events were collected at Week 2, 4, 6, 8

Additional Information

Dr. Daniel Hsia

Pennington Biomedical Research Center

Phone: 225-763-3000

Email: clinicaltrials@pbrc.edu

Results disclosure agreements

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