BronchiolitisNCT00863317
Trial of Montelukast for Treatment of Acute Bronchiolitis
A study testing montelukast sodium and sucrose in people with Bronchiolitis, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The primary rationale for this study is to evaluate the effect of once daily montelukast on duration of acute illness in infants with first-time bronchiolitis. Read more about this study
- Who is it for?
- Ages 3 to 12 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- montelukast sodium and sucrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jul 2011
- 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 3 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female infants aged 3 to 12 months of age
- Diagnosis by emergency physician of bronchiolitis
Who cannot join
- Any previous episode, as determined by a physician, of wheezing, bronchiolitis or asthma
- Any history of previous bronchodilator use prior to this illness
- Treatment with corticosteroids in the 14 days prior to the current illness
- Immunosuppression
- Immunodeficiency
- Caregiver does not speak English
Show all 9Show fewer
- Diagnosis by the treating ED physician of croup
- Diagnosis by the treating ED physician of pneumonia
- Caregiver does not have access to a telephone
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Trial of Daily Montelukast for the Treatment of Viral Bronchiolitis
The primary rationale for this study is to evaluate the effect of once daily montelukast on duration of acute illness in infants with first-time bronchiolitis.
- Conditions
- Bronchiolitis
- Being tested
- montelukast sodium, sucrose
- Keywords
- Bronchiolitis, montelukast, leukotriene inhibitor
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montelukast sodiumDrug
Also called singulair
4mg granules daily for 14 days
sucroseOther
table sugar as placebo daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| montelukast sodium | Experimental | 4mg granules PO QD for 14 days Receives: Drug: montelukast sodium |
| Placebo | Placebo comparator | Sucrose granules PO QD for 14 days Receives: Other: sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Cough
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startDec 2008
- Primary completionJul 2011
- Study completionJul 2011
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.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Petruzella, Medical College of Wisconsin
- Investigators
- Marc Gorelick, MD, MSCE, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863317
- Sponsor's protocol ID
- FDP-01
- Other IDs
- IND 103263
- Status last verified
- Jun 2015
- First submitted
- 16 Mar 2009
- Last updated
- 15 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Trial of Daily Montelukast for the Treatment of Viral Bronchiolitis
- ClinicalTrials.gov ID
- NCT00863317
- Acronym / sponsor ID
- FDP-01
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, montelukast, leukotriene inhibitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Posted 19 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary rationale for this study is to evaluate the effect of once daily montelukast on duration of acute illness in infants with first-time bronchiolitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| montelukast sodium | Experimental | Drug: montelukast sodium4mg granules PO QD for 14 days |
| Placebo | Placebo comparator | Other: sucroseSucrose granules PO QD for 14 days |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male or female infants aged 3 to 12 months of age
- Diagnosis by emergency physician of bronchiolitis
Key exclusion criteria (9 listed)
- Any previous episode, as determined by a physician, of wheezing, bronchiolitis or asthma
- Any history of previous bronchodilator use prior to this illness
- Treatment with corticosteroids in the 14 days prior to the current illness
- Immunosuppression
- Immunodeficiency
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 |
|---|---|---|
| montelukast sodiumAlso: singulair4mg granules daily for 14 days | Drug | montelukast sodium |
| sucrosetable sugar as placebo daily for 14 days | Other | Placebo |
Primary outcome
Duration of Cough
Time frame: up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Marc Gorelick, MD, MSCE principal investigator
Medical College of Wisconsin
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 sodium and sucrose in people with Bronchiolitis, run by Medical College of Wisconsin 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 9 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 15 Jul 2015. 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 19 Jun 2015). 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?
Duration of Cough (time frame: up to 4 weeks). 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 15 Jul 2015.