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Leukotriene Modifier

Montelukast for Asthma

N/A

Waitlist Available

Led By Corrie Fletcher, DO

Research Sponsored by Corrie Fletcher

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Requiring PICU admission for status asthmaticus

Pediatric asthma score > 8 on admission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up hourly during the length of the patient's pediatric icu hospitalization for status asthmaticus

Awards & highlights

Study Summary

This trial is testing whether the addition of montelukast to standard asthma treatments can help improve symptoms in children with status asthmaticus.

Who is the study for?

This trial is for children aged 2-18 with a severe asthma attack, known as status asthmaticus, who need intensive care and can take pills. It's not for those already on montelukast, with certain allergies or conditions like PKU, or taking specific drugs like rifampin.Check my eligibility

What is being tested?

The study tests if oral montelukast (Singulair), along with standard treatments, shortens the recovery from severe asthma attacks in hospitalized children compared to a placebo.See study design

What are the potential side effects?

Montelukast is generally safe but may cause side effects such as stomach pain, thirst, headache, tiredness and trouble sleeping. Rarely it might lead to mood-related changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was admitted to the intensive care unit for a severe asthma attack.

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My child's asthma score was over 8 when admitted.

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I am between 2 and 148 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hourly during the length of the patient's pediatric icu hospitalization for status asthmaticus

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hourly during the length of the patient's pediatric icu hospitalization for status asthmaticus

This trial's timeline: 3 weeks for screening, Varies for treatment, and hourly during the length of the patient's pediatric icu hospitalization for status asthmaticus for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improvement of pediatric asthma score

Side effects data

From 2005 Phase 4 trial • 99 Patients • NCT00189462

16%

Cold/Upper Respiratory Infection

10%

Diarrhea

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Montelukast

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MontelukastExperimental Treatment1 Intervention

Montelukast 5mg capsules for 2-5 year old every 24h and 8mg capsules for 6-14 year olds every 24h.

Group II: PlaceboPlacebo Group1 Intervention

One placebo capsule given every 24h

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Montelukast

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Corrie FletcherLead Sponsor

Corrie Fletcher, DOPrincipal InvestigatorAdvocate Health Care

Media Library

Montelukast (Leukotriene Modifier) Clinical Trial Eligibility Overview. Trial Name: NCT01770899 — N/A

Asthma Research Study Groups: Montelukast, Placebo

Asthma Clinical Trial 2023: Montelukast Highlights & Side Effects. Trial Name: NCT01770899 — N/A

Montelukast (Leukotriene Modifier) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01770899 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What has been the traditional purpose of Montelukast?

"Montelukast can be employed to alleviate exercise-induced bronchospasm and various other respiratory conditions, including perennial allergic rhinitis (PAR), seasonal allergic rhinitis, and asthma."

Answered by AI

Are there any remaining opportunities to volunteer for this experiment?

"Clinicaltrials.gov indicates that this trial, which had its inception on January 1st 2013 and was last updated in late February of the same year is not currently seeking participants. Nevertheless, 24 other trials are actively recruiting patients at present."

Answered by AI

Is there an opportunity for me to sign up and participate in this clinical trial?

"The team conducting this medical trial is looking for 100 minors aged between 2 and 14 that have status asthmaticus. To be eligible, they must also meet the following specifications: (1) Between ages 2-148 years; (2) Requiring PICU admission due to their condition; (3) Capable of consuming oral medications; And (4) Presenting with a pediatric asthma score greater than 8 upon admittance."

Answered by AI

How many participants can this research accommodate?

"At present, this trial is not taking on any new participants. Originally posted January 1st 2013 and last modified February 22nd 2013, individuals seeking a clinical study may find two trials actively recruiting for status asthmaticus or twenty-two studies with Montelukast in need of volunteers."

Answered by AI

Could individuals older than 75 years participate in this research?

"According to the eligibility criteria for this medical trial, patients must be between 2 and 14 years old. 11 clinical trials are available for minors while a further 11 exist specifically for those over 65."

Answered by AI

Has any other research been conducted regarding the use of Montelukast?

"Currently, 22 trials related to Montelukast are in progress. 6 of those clinical studies are currently operating at the third tier of research. Most investigations take place in Lexington, Kentucky but 221 sites globally also have ongoing research dedicated to this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation Montelukast in the Treatment of Status Asthmaticus

Corrie Fletcher 2013. "Evaluation Montelukast in the Treatment of Status Asthmaticus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01770899.

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