Trial Outcomes & Findings for The Effect of Montelukast on Asthma Control in Overweight/Obese Atopic Asthmatics (NCT NCT01329939)

NCT ID: NCT01329939

Last Updated: 2016-04-07

Results Overview

The ACT is a validated questionaire-based tool designed to assess asthma control. Scale range for 7-11 year olds is 0-27 and for 12 years and older 5-25, with lower scores indicating poorer asthma control for all ages. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2016-04-07

Participant Flow

Atopic asthmatics age seven and above seen in pulmonary and allergy clinics were approached over a 2.5 year period.

Potential subjects underwent spirometry with bronchodilator administration if there was no previous documentation and allergy testing (skin/blood) to evaluate for environmental allergies.There was a four to six week run-in period where all participants were maintained on an inhaled corticosteroid before randomization.

Participant milestones

Measure	Overweight/Obese Atopic Asthmatics, Montelukast Montelukast: Age-dependent dose, nightly, 24 weeks	Normal-weight Atopic Asthmatics, Placebo Placebo: Age-dependent dose, nightly, 24 weeks	Normal Weight Atopic Asthmatics, Montelukast Montelukast: Age-dependent dose, nightly, 24 weeks	Overweight/Obese Atopic Asthmatics, Placebo Placebo: Age-dependent dose, nightly, 24 weeks
Overall Study STARTED	7	5	5	9
Overall Study COMPLETED	4	4	4	4
Overall Study NOT COMPLETED	3	1	1	5

Reasons for withdrawal

Measure	Overweight/Obese Atopic Asthmatics, Montelukast Montelukast: Age-dependent dose, nightly, 24 weeks	Normal-weight Atopic Asthmatics, Placebo Placebo: Age-dependent dose, nightly, 24 weeks	Normal Weight Atopic Asthmatics, Montelukast Montelukast: Age-dependent dose, nightly, 24 weeks	Overweight/Obese Atopic Asthmatics, Placebo Placebo: Age-dependent dose, nightly, 24 weeks
Overall Study Lost to Follow-up	3	0	1	2
Overall Study Withdrawal by Subject	0	1	0	0
Overall Study Adverse Event	0	0	0	3

Baseline Characteristics

The Effect of Montelukast on Asthma Control in Overweight/Obese Atopic Asthmatics

Baseline characteristics by cohort

Measure	Obese Atopic Asthmatics, Montelukast n=7 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Normal-weight Atopic Asthmatics, Placebo n=5 Participants Placebo: Age-dependent dose, nightly, 24 weeks	Normal Weight Atopic Asthmatics, Montelukast n=5 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Obese Atopic Asthmatics, Placebo n=9 Participants Placebo: Age-dependent dose, nightly, 24 weeks	Total n=26 Participants Total of all reporting groups
Age, Continuous	10 years n=5 Participants	9 years n=7 Participants	10 years n=5 Participants	9 years n=4 Participants	10 years n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	14 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants
Race/Ethnicity, Customized Caucasian	2 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	2 participants n=4 Participants	9 participants n=21 Participants
Race/Ethnicity, Customized African-American	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants	5 participants n=21 Participants
Race/Ethnicity, Customized Hispanic	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	4 participants n=21 Participants
Race/Ethnicity, Customized Other	4 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	8 participants n=21 Participants
Region of Enrollment United States	7 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	9 participants n=4 Participants	26 participants n=21 Participants
Height (cm)	153.30 cm n=5 Participants	134.4 cm n=7 Participants	143.00 cm n=5 Participants	144.90 cm n=4 Participants	143.95 cm n=21 Participants
Weight (kg)	72.3 kg n=5 Participants	32.66 kg n=7 Participants	37.00 kg n=5 Participants	52.00 kg n=4 Participants	48.50 kg n=21 Participants
BMI	30.76 kg/m^2 n=5 Participants	17.83 kg/m^2 n=7 Participants	18.28 kg/m^2 n=5 Participants	24.20 kg/m^2 n=4 Participants	22.09 kg/m^2 n=21 Participants

PRIMARY outcome

Timeframe: 24 weeks

The ACT is a validated questionaire-based tool designed to assess asthma control. Scale range for 7-11 year olds is 0-27 and for 12 years and older 5-25, with lower scores indicating poorer asthma control for all ages. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.

Outcome measures

Measure	Overweight/Obese Atopic Asthmatics, Montelukast n=4 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Normal-weight Atopic Asthmatics, Placebo n=4 Participants Placebo: Age-dependent dose, nightly, 24 weeks	Normal Weight Atopic Asthmatics, Montelukast n=4 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Overweight/Obese Atopic Asthmatics, Placebo n=4 Participants Placebo: Age-dependent dose, nightly, 24 weeks
Asthma Control Test (ACT) Scores	25.00 units on a scale Interval 22.4 to 27.6	20.5 units on a scale Interval 13.81 to 29.19	24.00 units on a scale Interval 20.1 to 27.9	15.75 units on a scale Interval 3.82 to 27.68

SECONDARY outcome

Timeframe: 24 weeks

Breathing maneuvers which help to measure obstruction of airways. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.

Outcome measures

Measure	Overweight/Obese Atopic Asthmatics, Montelukast n=4 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Normal-weight Atopic Asthmatics, Placebo n=4 Participants Placebo: Age-dependent dose, nightly, 24 weeks	Normal Weight Atopic Asthmatics, Montelukast n=4 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Overweight/Obese Atopic Asthmatics, Placebo n=4 Participants Placebo: Age-dependent dose, nightly, 24 weeks
Spirometric Measures FEV1%	83.37 percent predicted Interval 66.57 to 100.16	85.31 percent predicted Interval 64.27 to 106.35	97.87 percent predicted Interval 66.55 to 129.19	71.79 percent predicted Interval 47.86 to 95.32
Spirometric Measures FVC%	91.01 percent predicted Interval 65.4 to 116.62	88.87 percent predicted Interval 57.89 to 119.85	101.68 percent predicted Interval 69.49 to 133.86	76.21 percent predicted Interval 50.07 to 102.36
Spirometric Measures FEV1/FVC	83.13 percent predicted Interval 77.57 to 89.05	89.35 percent predicted Interval 76.38 to 102.31	88.25 percent predicted Interval 75.01 to 101.48	80.42 percent predicted Interval 63.06 to 97.79
Spirometric Measures FEF 25-75%	87.62 percent predicted Interval 47.7 to 127.54	78.57 percent predicted Interval 46.25 to 110.88	103.77 percent predicted Interval 49.52 to 158.02	66.99 percent predicted Interval 29.08 to 104.9
Spirometric Measures PEF (peak expiratory flow)%	100.19 percent predicted Interval 71.25 to 129.12	74.44 percent predicted Interval 65.05 to 83.84	108.09 percent predicted Interval 74.63 to 141.55	92.79 percent predicted Interval 60.85 to 124.73

SECONDARY outcome

Timeframe: 24 weeks

Leptin levels, measured through blood, mediate appetite and are elaborated by adipose tissue. Levels correlate positively with body fat percentage. In addition, leptin plays a role in producing an inflammatory state. Adiponectin, which is also secreted by adipose tissue, regulates metabolism, however its levels are inversely correlated with body fat percentage.

Outcome measures

Measure	Overweight/Obese Atopic Asthmatics, Montelukast n=4 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Normal-weight Atopic Asthmatics, Placebo n=4 Participants Placebo: Age-dependent dose, nightly, 24 weeks	Normal Weight Atopic Asthmatics, Montelukast n=4 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Overweight/Obese Atopic Asthmatics, Placebo n=4 Participants Placebo: Age-dependent dose, nightly, 24 weeks
Serum Leptin Levels Serum leptin level	44.35 ng/mL Interval 29.66 to 59.04	4.13 ng/mL Interval 0.77 to 7.48	10.90 ng/mL Interval -14.08 to 35.88	34.88 ng/mL Interval -0.15 to 69.9
Serum Leptin Levels serum adiponectin	10.27 ng/mL Interval 5.66 to 14.88	11.35 ng/mL Interval 0.98 to 21.72	13.08 ng/mL Interval 7.73 to 18.42	9.52 ng/mL Interval -0.86 to 19.91

SECONDARY outcome

Timeframe: 24 weeks

Population: One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks.

LTE4 levels, measured in the urine, reflect the degree of inflammation in the asthmatic airway. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.

Outcome measures

Measure	Overweight/Obese Atopic Asthmatics, Montelukast n=4 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Normal-weight Atopic Asthmatics, Placebo n=3 Participants Placebo: Age-dependent dose, nightly, 24 weeks	Normal Weight Atopic Asthmatics, Montelukast n=4 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Overweight/Obese Atopic Asthmatics, Placebo n=4 Participants Placebo: Age-dependent dose, nightly, 24 weeks
Urinary Leukotriene E4 (LTE4) Levels	171.50 pg/mL Interval 39.4 to 303.6	195.67 pg/mL Interval -460.66 to 852.0	198.00 pg/mL Interval -80.55 to 476.55	313.00 pg/mL Interval -227.82 to 853.82

SECONDARY outcome

Timeframe: 24 weeks

A non-invasive measure of eosinophilic airway inflammation. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.

Outcome measures

Measure	Overweight/Obese Atopic Asthmatics, Montelukast n=4 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Normal-weight Atopic Asthmatics, Placebo n=4 Participants Placebo: Age-dependent dose, nightly, 24 weeks	Normal Weight Atopic Asthmatics, Montelukast n=4 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Overweight/Obese Atopic Asthmatics, Placebo n=4 Participants Placebo: Age-dependent dose, nightly, 24 weeks
Exhaled Nitric Oxide Measurement	14.33 ppb Interval -13.14 to 41.81	27.25 ppb Interval -13.9 to 68.4	25.75 ppb Interval -18.07 to 69.57	39.5 ppb Interval 1.7 to 77.2

SECONDARY outcome

Timeframe: 24 weeks

The total daily dose of inhaled corticosteroids in beclomethasone equivalents. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.

Outcome measures

Measure	Overweight/Obese Atopic Asthmatics, Montelukast n=4 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Normal-weight Atopic Asthmatics, Placebo n=4 Participants Placebo: Age-dependent dose, nightly, 24 weeks	Normal Weight Atopic Asthmatics, Montelukast n=4 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Overweight/Obese Atopic Asthmatics, Placebo n=4 Participants Placebo: Age-dependent dose, nightly, 24 weeks
Beclomethasone Equivalents	680 micrograms Interval 257.8 to 1102.2	740 micrograms Interval 172.79 to 1652.79	580 micrograms Interval 302.56 to 857.44	1210.00 micrograms Interval 456.22 to 1963.78

SECONDARY outcome

Timeframe: 24 weeks

Population: One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks.

Creatinine, measured in the urine, reflects how well the kidneys are working, and provide a standard to which one can compare other metabolites in the urine. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.

Outcome measures

Measure	Overweight/Obese Atopic Asthmatics, Montelukast n=4 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Normal-weight Atopic Asthmatics, Placebo n=3 Participants Placebo: Age-dependent dose, nightly, 24 weeks	Normal Weight Atopic Asthmatics, Montelukast n=4 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Overweight/Obese Atopic Asthmatics, Placebo n=4 Participants Placebo: Age-dependent dose, nightly, 24 weeks
Urinary Creatinine (Cr) Levels	1.7 mg/mL Interval 0.95 to 2.45	1.69 mg/mL Interval -0.36 to 3.75	1.77 mg/mL Interval -0.18 to 3.73	2.77 mg/mL Interval 0.63 to 4.91

SECONDARY outcome

Timeframe: 24 weeks

Population: One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks.

The ratio of urinary LTE4 to Cr provides a standardization of the LTE4 level based on the patients weight and muscle mass, therefore normalizing it across the different subjects. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.

Outcome measures

Measure	Overweight/Obese Atopic Asthmatics, Montelukast n=4 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Normal-weight Atopic Asthmatics, Placebo n=3 Participants Placebo: Age-dependent dose, nightly, 24 weeks	Normal Weight Atopic Asthmatics, Montelukast n=4 Participants Montelukast: Age-dependent dose, nightly, 24 weeks	Overweight/Obese Atopic Asthmatics, Placebo n=4 Participants Placebo: Age-dependent dose, nightly, 24 weeks
Urinary Creatinine (Cr) Levels/Leukotriene E4 (LTE4) Ratio	105.87 pg/mg Interval 16.09 to 195.65	99.61 pg/mg Interval -145.44 to 344.67	159.84 pg/mg Interval -52.3 to 371.96	177.92 pg/mg Interval -190.08 to 545.91

Adverse Events

Overweight/Obese Atopic Asthmatics, Montelukast

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal-weight Atopic Asthmatics, Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Weight Atopic Asthmatics, Montelukast

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Overweight/Obese Atopic Asthmatics, Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Overweight/Obese Atopic Asthmatics, Montelukast n=7 participants at risk Montelukast: Age-dependent dose, nightly, 24 weeks	Normal-weight Atopic Asthmatics, Placebo n=5 participants at risk Placebo: Age-dependent dose, nightly, 24 weeks	Normal Weight Atopic Asthmatics, Montelukast n=5 participants at risk Montelukast: Age-dependent dose, nightly, 24 weeks	Overweight/Obese Atopic Asthmatics, Placebo n=9 participants at risk Placebo: Age-dependent dose, nightly, 24 weeks
General disorders Mood changes	0.00% 0/7	0.00% 0/5	0.00% 0/5	33.3% 3/9 • Number of events 3

Additional Information

Dr. Sherry Farzan, Attending Physician, Assistant Professor of Medicine and Pediatrics

North Shore - Long Island Jewish Health System; Hofstra North Shore-LIJ School of Medicine

Phone: 5166225070

Email: sfarzan@nshs.edu

Results disclosure agreements

• Principal investigator is a sponsor employee "You shall have the right to publish the results derived from your performance of the Study. You agree to submit a copy of...Study results ("Publication") to Merck for comment sixty (60) days prior to its submission for publication. Merck shall have the applicable sixty (60) day period to respond to you with any requested revisions. You agree to delete any confidential information (excluding results) identified by Merck as confidential prior to submitting/presenting the Publication....."
• Publication restrictions are in place

Restriction type: OTHER