AsthmaNCT01329939
The Effect of Montelukast on Asthma Control in Overweight/Obese Atopic Asthmatics
A study testing Montelukast in people with Asthma and Obesity, run by Northwell Health at 1 site in United States.
Trial summary
Background: In recent years, the prevalence of both asthma and obesity has risen dramatically among children and adolescents in the United States. Given the concurrent rise in the two epidemics, there may be an underlying link. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Asthma, Obesity, Inflammation
- What is being tested?
- Montelukast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- mild to moderate persistent asthma based on 2007 NIH Asthma Guidelines
- age 7-17 years old
Who cannot join
- present smoking or smoking history
- other significant pulmonary or cardiac condition
- recent (within the past three months) use of montelukast
- on allergen immunotherapy
- on omalizumab
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore-Long Island Jewish Health System, Division of Allergy/Immunology
Great Neck, New York, 11023
About this study
Background: In recent years, the prevalence of both asthma and obesity has risen dramatically among children and adolescents in the United States. Given the concurrent rise in the two epidemics, there may be an underlying link. Obesity contributes to asthma severity and control, and may play a role in its underlying cause. Obesity is associated with a state of heightened inflammation that may lead to an increase asthma symptoms and severity. Obese adult patients treated with montelukast, an anti-inflammatory agent, seemed to have better asthma control than those treated with other standard asthma medications. The use of montelukast in obese children and adolescents has not been specifically studied.
Hypotheses and Specific Aims: The use of montelukast will improve asthma symptoms and objective markers of asthma to a greater degree in obese, as opposed to non-obese children and adolescents. The investigators would like to determine if the use of montelukast will improve objective asthma scores, pulmonary function, markers of inflammation and medication use to a greater degree in obese as opposed to non-obese children/adolescents.
Potential Impact: Given the growing epidemic of obesity-associated asthma in the U.S., a tailored approach focused on obese asthmatic children may help reduce the burden of this disease, health care costs and potential long-term complications as these children enter adulthood. Furthermore, this study may help clarify the underlying mechanisms that link asthma and obesity. Although this proposal is focused on one medication, it provides an example of how certain medications may have differential efficacy in the obese asthmatic.
- Conditions
- Asthma, Obesity, Inflammation
- Being tested
- Montelukast, Placebo
- Keywords
- Asthma, Obesity, Pediatric, Inflammation, Leukotriene, Montelukast
- Medical subject headings
- Asthma, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Also called Singulair
Age-dependent dose, nightly, 24 weeks
PlaceboDrug
Age-dependent dose, nightly, 24 weeks
MontelukastDrug
Also called Singulair
Age-dependent dose, nightly, 24 weeks
PlaceboDrug
Age-dependent dose, nightly, 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Obese atopic asthmatics, montelukast | Experimental | Obese/overweight (BMI 85%ile or above for children and > 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive montelukast in a double blinded fashion. Receives: Drug: Montelukast |
| Lean atopic asthmatics, placebo | Placebo comparator | Normal weight (BMI less than 85%ile or above for children and < 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive placebo in a double blinded fashion. Receives: Drug: Placebo |
| Lean atopic asthmatics, montelukast | Active comparator | Normal weight (BMI less than 85%ile or above for children and < 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive montelukast in a double blinded fashion. Receives: Drug: Montelukast |
| Obese atopic asthmatics, Placebo | Placebo comparator | Obese/overweight (BMI 85%ile or above for children and > 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive placebo in a double blinded fashion. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Test (ACT) Scores
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.
Measured: 24 weeks
Secondary outcomes (7)
Spirometric Measures
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.
Measured: 24 weeks
Serum Leptin Levels
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.
Measured: 24 weeks
Urinary Leukotriene E4 (LTE4) Levels
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.
Measured: 24 weeks
Exhaled Nitric Oxide Measurement
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.
Measured: 24 weeks
Beclomethasone Equivalents
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.
Measured: 24 weeks
Urinary Creatinine (Cr) Levels
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.
Measured: 24 weeks
Urinary Creatinine (Cr) Levels/Leukotriene E4 (LTE4) Ratio
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund, Merck Sharp & Dohme LLC, New York State Department of Health
- Responsible party
- Principal investigator, Sherry Farzan Kashani, Northwell Health
- Investigators
- Sherry Farzan, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329939
- Sponsor's protocol ID
- 10-029B
- Status last verified
- Mar 2016
- First submitted
- 23 Mar 2011
- Last updated
- 7 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Farzan S, Khan S, Elera C, Tsang J, Akerman M, DeVoti J. Effectiveness of montelukast in overweight and obese atopic asthmatics. Ann Allergy Asthma Immunol. 2017 Aug;119(2):189-190. doi: 10.1016/j.anai.2017.05.024. Epub 2017 Jun 28. No abstract available.
PubMed 28668546
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Montelukast on Asthma Control in Overweight/Obese Atopic Asthmatics
- ClinicalTrials.gov ID
- NCT01329939
- Acronym / sponsor ID
- 10-029B
- Conditions
- Asthma, Obesity, Inflammation
- Keywords
- Asthma, Obesity, Pediatric, Inflammation, Leukotriene, Montelukast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Thrasher Research Fund, Merck Sharp & Dohme LLC, New York State Department of Health
- Study start
- Apr 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Posted 7 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: In recent years, the prevalence of both asthma and obesity has risen dramatically among children and adolescents in the United States. Given the concurrent rise in the two epidemics, there may be an underlying link. Obesity contributes to asthma severity and control, and may play a role in its underlying cause. Obesity is associated with a state of heightened inflammation that may lead to an increase asthma symptoms and severity. Obese adult patients treated with montelukast, an anti-inflammatory agent, seemed to have better asthma control than those treated with other standard asthma medications. The use of montelukast in obese children and adolescents has not been specifically studied.
Hypotheses and Specific Aims: The use of montelukast will improve asthma symptoms and objective markers of asthma to a greater degree in obese, as opposed to non-obese children and adolescents. The investigators would like to determine if the use of montelukast will improve objective asthma scores, pulmonary function, markers of inflammation and medication use to a greater degree in obese as opposed to non-obese children/adolescents.
Potential Impact: Given the growing epidemic of obesity-associated asthma in the U.S., a tailored approach focused on obese asthmatic children may help reduce the burden of this disease, health care costs and potential long-term complications as these children enter adulthood. Furthermore, this study may help clarify the underlying mechanisms that link asthma and obesity. Although this proposal is focused on one medication, it provides an example of how certain medications may have differential efficacy in the obese asthmatic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obese atopic asthmatics, montelukast | Experimental | Drug: MontelukastObese/overweight (BMI 85%ile or above for children and > 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive montelukast in a double blinded fashion. |
| Lean atopic asthmatics, placebo | Placebo comparator | Drug: PlaceboNormal weight (BMI less than 85%ile or above for children and < 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive placebo in a double blinded fashion. |
| Lean atopic asthmatics, montelukast | Active comparator | Drug: MontelukastNormal weight (BMI less than 85%ile or above for children and < 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive montelukast in a double blinded fashion. |
| Obese atopic asthmatics, Placebo | Placebo comparator | Drug: PlaceboObese/overweight (BMI 85%ile or above for children and > 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive placebo in a double blinded fashion. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- mild to moderate persistent asthma based on 2007 NIH Asthma Guidelines
- age 7-17 years old
Key exclusion criteria (6 listed)
- present smoking or smoking history
- other significant pulmonary or cardiac condition
- recent (within the past three months) use of montelukast
- on allergen immunotherapy
- on omalizumab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MontelukastAlso: SingulairAge-dependent dose, nightly, 24 weeks | Drug | Lean atopic asthmatics, montelukast |
| PlaceboAge-dependent dose, nightly, 24 weeks | Drug | Lean atopic asthmatics, placebo |
| MontelukastAlso: SingulairAge-dependent dose, nightly, 24 weeks | Drug | Obese atopic asthmatics, montelukast |
| PlaceboAge-dependent dose, nightly, 24 weeks | Drug | Obese atopic asthmatics, Placebo |
Primary outcome
Asthma Control Test (ACT) Scores
Time frame: 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.
7 secondary outcomes
Spirometric Measures
Time frame: 24 weeks
Serum Leptin Levels
Time frame: 24 weeks
Urinary Leukotriene E4 (LTE4) Levels
Time frame: 24 weeks
Exhaled Nitric Oxide Measurement
Time frame: 24 weeks
Beclomethasone Equivalents
Time frame: 24 weeks
Urinary Creatinine (Cr) Levels
Time frame: 24 weeks
Urinary Creatinine (Cr) Levels/Leukotriene E4 (LTE4) Ratio
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28668546Farzan S, Khan S, Elera C, Tsang J, Akerman M, DeVoti J. Effectiveness of montelukast in overweight and obese atopic asthmatics. Ann Allergy Asthma Immunol. 2017 Aug;119(2):189-190. doi: 10.1016/j.anai.2017.05.024. Epub 2017 Jun 28. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherry Farzan, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Montelukast in people with Asthma and Obesity, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Test (ACT) Scores (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01329939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2016.