Status AsthmaticusPhase 2/3NCT00494572
Montelukast With Status Asthmaticus, Ages 6-18
A Phase 2/3 study testing Montelukast and sterile water in people with Status Asthmaticus and Asthma, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
The purpose of this study is to determine if montelukast, in addition to standard treatment is helpful in treating patients ages 6-18 who are in the hospital because of status asthmaticus. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Status Asthmaticus, Asthma
- What is being tested?
- Montelukast and sterile water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Oct 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant's parent/legal guardian must give written informed consent and written assent must be obtained form the subject prior to study participation.
- Obtain consent of the parent/legal guardian using a signed consent form;
- Obtain assent form minors between the ages of 7-13 using a signed assent form;
- Obtain assent from minors between the ages of 14-17 by having the subject sign the consent formed signed the parent / legal guardian (Or based on the assessment by the Primary Investigator that the patient is unable to comprehend the study as written in the consent form document, the patient may document assent by signing the assent form).
- Participant, male or female, must be 6 to 18 years of age.
- Participant must have a history of reactive airway disease (RAD) or asthma and must currently be admitted for an acute exacerbation of RAD or asthma.
Show all 14Show fewer
- Primary physician must believe that patient would benefit from improved bronchodilation and improvement in clinical asthma severity score.
- Participant must have received standard therapy for status asthmaticus:
- Oxygen as needed
- >3 nebulized albuterol treatments of at least 2.5mg/dose
- Methylprednisolone or prednisone loading dose of 2mg/kg
- Ongoing methylprednisolone therapy @ 0.5mg/kg every 6 hours
- Participant must have received steroids at least 6 hours prior to their inclusion, and must still require nebulized albuterol at least every 2 hours, as determined by PICU team in accordance with the PICU standard for evaluating and treating patients with RAD or asthma exacerbations.
- Participant must have an indwelling catheter in place from which to obtain blood specimens. Catheter may be peripheral or central, arterial or venous.
Who cannot join
- Known hypersensitivity to montelukast
- Chronic lung disease other than RAD or asthma
- Known renal disease
- Known hepatic disease
- Cardiac or pulmonary congenital anomalies
- Known immunologic disorders other than allergy and atopy
Show all 11Show fewer
- Other explanations for respiratory distress
- Use of leukotriene modifiers within 2 weeks of the acute presentation
- Pregnant females
- Intubated patients
- Inability to participate in portable spirometry for FEV1 measurement
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Eloise Lemon, RN, 216-844-3681, eloise.lemon@uhhs.com
Jeffrey Blumer, Ph.D., M.D.
About this study
Official title: Pharmacokinetics and Pharmacodynamics of Montelukast in Children, Ages 6 Through 18 Years Old, With Status Asthmaticus Unresponsive to Conventional Treatment
The purpose of this study is to determine if montelukast, in addition to standard treatment is helpful in treating patients ages 6-18 who are in the hospital because of status asthmaticus.
Read the detailed description
This is a prospective study of montelukast efficacy in addition to standard treatment of status asthmaticus in children who are in the PICU. The study will be stratified in 2 groups: children 6-12 years of age and adolescents 13-18 years of age. Children who meet eligibility requirements will be randomized to receive a rapid-dissolving oral dose of montelukast or placebo. Participants will be given a physical exam, have FEV1 measurements and clinical asthma scores recorded pre- and post- completion of a nebulized albuterol treatment of 0.1 mg/kg/dose (min 2.5 mg/dose). Blood samples for PK analysis will be collected prior to study drug administration and at predetermined time intervals to determine the plasma level of montelukast. In addition, a blood sample will be obtained for genetic study of polymorphisms of CYP3A4, CYP3A5, and CYP2C9.
- Conditions
- Status Asthmaticus, Asthma
- Being tested
- Montelukast, sterile water
- Keywords
- Montelukast, Albuterol, Status Asthmaticus, Asthma
- Medical subject headings
- Status Asthmaticus, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
10 mg rapid dissolving granule in sterile water orally once
sterile waterOther
sterile water
| Study group | Role | What they receive |
|---|---|---|
| Sterile Water | Sham comparator | Sterile water Receives: Other: sterile water |
| Montelukast | Active comparator | 10mg rapid dissolving granules in sterile water orally once Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate effectiveness of Montelukast as adjunctive therapy
Secondary outcomes (1)
Estimate the first dose pharmacokinetic parameter of Montelukast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startDec 2006
- Primary completionJan 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status AsthmaticusStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Pediatric Pharmacology Research Units Network
- Investigators
- Jeffrey Blumer, MD, Principal investigator, PPRU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494572
- Sponsor's protocol ID
- PPRU 10856
- Status last verified
- Nov 2008
- First submitted
- 28 Jun 2007
- Last updated
- 16 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Montelukast in Children, Ages 6 Through 18 Years Old, With Status Asthmaticus Unresponsive to Conventional Treatment
- ClinicalTrials.gov ID
- NCT00494572
- Acronym / sponsor ID
- PPRU 10856
- Conditions
- Status Asthmaticus, Asthma
- Keywords
- Montelukast, Albuterol, Status Asthmaticus, Asthma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- Pediatric Pharmacology Research Units Network
- Study start
- Dec 2006
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 29 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if montelukast, in addition to standard treatment is helpful in treating patients ages 6-18 who are in the hospital because of status asthmaticus.
Detailed description
This is a prospective study of montelukast efficacy in addition to standard treatment of status asthmaticus in children who are in the PICU. The study will be stratified in 2 groups: children 6-12 years of age and adolescents 13-18 years of age. Children who meet eligibility requirements will be randomized to receive a rapid-dissolving oral dose of montelukast or placebo. Participants will be given a physical exam, have FEV1 measurements and clinical asthma scores recorded pre- and post- completion of a nebulized albuterol treatment of 0.1 mg/kg/dose (min 2.5 mg/dose). Blood samples for PK analysis will be collected prior to study drug administration and at predetermined time intervals to determine the plasma level of montelukast. In addition, a blood sample will be obtained for genetic study of polymorphisms of CYP3A4, CYP3A5, and CYP2C9.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sterile Water | Sham comparator | Other: sterile waterSterile water |
| Montelukast | Active comparator | Drug: Montelukast10mg rapid dissolving granules in sterile water orally once |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Participant's parent/legal guardian must give written informed consent and written assent must be obtained form the subject prior to study participation.
- Participant, male or female, must be 6 to 18 years of age.
- Participant must have a history of reactive airway disease (RAD) or asthma and must currently be admitted for an acute exacerbation of RAD or asthma.
- Primary physician must believe that patient would benefit from improved bronchodilation and improvement in clinical asthma severity score.
- Participant must have received standard therapy for status asthmaticus:
Key exclusion criteria (11 listed)
- Known hypersensitivity to montelukast
- Chronic lung disease other than RAD or asthma
- Known renal disease
- Known hepatic disease
- Cardiac or pulmonary congenital anomalies
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 |
|---|---|---|
| Montelukast10 mg rapid dissolving granule in sterile water orally once | Drug | Montelukast |
| sterile watersterile water | Other | Sterile Water |
Primary outcome
Evaluate effectiveness of Montelukast as adjunctive therapy
1 secondary outcome
Estimate the first dose pharmacokinetic parameter of Montelukast
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2008.
Related trials for Status Asthmaticus
Not yet recruiting
Efficacy of High-Dose Continuous Intravenous Magnesium Sulfate Infusion vs Standard Intravenous Magnesium Sulfate Therapy in Status Asthmaticus in the ED
Asthma Exacerbation, Emergency Department
RecruitingPhase 2
Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma
Asthma (Diagnosis)
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.
Jeffrey Blumer, MD principal investigator
PPRU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Montelukast and sterile water in people with Status Asthmaticus and Asthma, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 14 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 Dec 2008. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate effectiveness of Montelukast as adjunctive therapy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2008.