Trial Outcomes & Findings for Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity (NCT NCT01158573)

Results Overview

Measurement of plasma leptin in obese and non obese asthmatics and non-asthmatic subjects from a single blood draw.

Recruitment status

COMPLETED

Target enrollment

117 participants

Primary outcome timeframe

Observational: one time point from a blood draw after more than 6 hours fasting

Results posted on

2018-01-24

Participant Flow

OA Obese Asthma BMI \>30 NANO Non asthma non obese ANO Asthma non obese NAO Non asthma obese BMI \>30 Started July 2010 completed May 2013

Pre-assignment weight determined and pulmonary function testing prior to enrollment in observational study One time point study when mediators were mesaured.

Participant milestones

Participant milestones
Measure	Obese Asthma Obese Asthma (OA) BMI \> 30 Obese Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use.	Non Asthma, Non-obese BMI 20-25 Non obese	Asthma, Non-obese BMI 20-25 Non obese	Non Asthma, Obese BMI .30
Overall Study STARTED	30	30	29	28
Overall Study COMPLETED	30	30	29	28
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Obese Asthma (OA) n=30 Participants BMI \> 30 Obese Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use.	Non Asthma Non-obese (NANO) n=30 Participants BMI 20-25 Non obese	Asthma Non Obese (ANO) n=29 Participants BMI 20-25 Non obese Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use.	Non Asthma Obese (NAO) n=28 Participants BMI \> 30 Obese	Total n=117 Participants Total of all reporting groups
Age, Continuous	44.0 years STANDARD_DEVIATION 10.3 • n=5 Participants	31.5 years STANDARD_DEVIATION 11.6 • n=7 Participants	29.9 years STANDARD_DEVIATION 9.8 • n=5 Participants	42.7 years STANDARD_DEVIATION 13.6 • n=4 Participants	37.0 years STANDARD_DEVIATION 13.6 • n=21 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	15 Participants n=7 Participants	20 Participants n=5 Participants	21 Participants n=4 Participants	77 Participants n=21 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	15 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	40 Participants n=21 Participants
BMI	38.9 kg/m^2 STANDARD_DEVIATION 6.1 • n=5 Participants	22.9 kg/m^2 STANDARD_DEVIATION 1.7 • n=7 Participants	22.8 kg/m^2 STANDARD_DEVIATION 1.7 • n=5 Participants	37.7 kg/m^2 STANDARD_DEVIATION 5.4 • n=4 Participants	30.8 kg/m^2 STANDARD_DEVIATION 9.2 • n=21 Participants

PRIMARY outcome

Timeframe: Observational: one time point from a blood draw after more than 6 hours fasting

Measurement of plasma leptin in obese and non obese asthmatics and non-asthmatic subjects from a single blood draw.

Outcome measures

Outcome measures
Measure	Obese Asthma (OA) n=30 Participants BMI \> 30 Obese Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use.	Non Asthma Non-obese (NANO) n=30 Participants BMI 20-25 Non obese	Asthma Non Obese (ANO) n=29 Participants BMI 20-25 Non obese Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use.	Non Asthma Obese (NAO) n=28 Participants BMI \> 30 Obese
Plasma Leptin	55.4 ng/ml Standard Deviation 26.9	8.9 ng/ml Standard Deviation 8.8	24.2 ng/ml Standard Deviation 12.9	46.5 ng/ml Standard Deviation 24.2

PRIMARY outcome

Timeframe: Observational: Two exhalations within 1 minute

Exhaled breath nitic oxide ppb (averaged values from 2 exhalations per participant)

Outcome measures

Outcome measures
Measure	Obese Asthma (OA) n=30 Participants BMI \> 30 Obese Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use.	Non Asthma Non-obese (NANO) n=30 Participants BMI 20-25 Non obese	Asthma Non Obese (ANO) n=29 Participants BMI 20-25 Non obese Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use.	Non Asthma Obese (NAO) n=28 Participants BMI \> 30 Obese
Exhaled Nitric Oxide (FeNO)	17.8 parts per billion (ppb) Standard Deviation 9.3	20.7 parts per billion (ppb) Standard Deviation 14.0	29.5 parts per billion (ppb) Standard Deviation 22.4	19.9 parts per billion (ppb) Standard Deviation 10.4

PRIMARY outcome

Timeframe: sample taken over 5 minutes or less

Urine inflammatory mediators measured from a single urine sample

Outcome measures

Outcome measures
Measure	Obese Asthma (OA) n=30 Participants BMI \> 30 Obese Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use.	Non Asthma Non-obese (NANO) n=30 Participants BMI 20-25 Non obese	Asthma Non Obese (ANO) n=29 Participants BMI 20-25 Non obese Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use.	Non Asthma Obese (NAO) n=28 Participants BMI \> 30 Obese
Urine Cysteinyl Leukotriene Per Creatinine	7.21 pg/mg creatinine Standard Deviation 3.2	6.35 pg/mg creatinine Standard Deviation 3.3	6.31 pg/mg creatinine Standard Deviation 2.65	6.67 pg/mg creatinine Standard Deviation 3.3

PRIMARY outcome

Timeframe: sample taken over 5 minutes or less

Responsiveness to leukotriene modifier medication by measuring the urine cysteinyl leukotriene/exhaled nitric oxide ratio

Outcome measures

Outcome measures
Measure	Obese Asthma (OA) n=30 Participants BMI \> 30 Obese Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use.	Non Asthma Non-obese (NANO) n=30 Participants BMI 20-25 Non obese	Asthma Non Obese (ANO) n=29 Participants BMI 20-25 Non obese Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use.	Non Asthma Obese (NAO) n=28 Participants BMI \> 30 Obese
Ratio U Cys-LT/FeNO	0.5 ratio Standard Deviation 0.4	0.42 ratio Standard Deviation 0.3	0.3 ratio Standard Deviation 0.21	0.44 ratio Standard Deviation 0.21

Adverse Events

Obese Asthma (OA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non Asthma Non-obese (NANO)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Asthma Non Obese (ANO)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non Asthma Obese (NAO)

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

Michael Coffey M.D.

University of Michigan

Phone: 734-936-6267

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place