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NCT00551382
Phase 3 Study of Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children
Phase 3 trial testing Muntelukast in Upper Respiratory Tract Infection in 500 participants. Status unknown.
1 December 2009
Quick facts
| Lead sponsor | Assaf-Harofeh Medical Center |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 500 |
| Start date | 1 November 2007 |
| Primary completion | 1 December 2009 |
| Estimated completion | 1 June 2010 |
| Sites | 3 locations across Israel |
Drugs / interventions tested
- Muntelukast — full drug profile →
- Placebo
Conditions studied
- Upper Respiratory Tract Infection — all drugs for Upper Respiratory Tract Infection →
Sponsor
Assaf-Harofeh Medical Center
Who can join
Adults 1 to 5, any sex, with Upper Respiratory Tract Infection. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The number and duration of URI episodes
Time frame: 3 month
Sponsor's own description
Viral upper respiratory tract infection (URI) is one of the most common diseases among toddlers and pre-school children.Complete and effective prevention measures for URI are currently unavailable. Montelukast (Singulair ) is a selective leukotriene-receptor antagonist that inhibits the cysteinyl leukotriene 1 receptor. It is well tolerated and safe even in young children. Montelukast is an effective treatment for asthma (and allergic rhinitis from 1 year of age. Infections with viruses causing URI such as Influenza A, Rhinovirus and respiratory syncitial virus increases leukotriens levels in nasal secretions. Therefore, one may postulate that leukotriens inhibitors may reduce symptoms during URI. However the effect of montelukast as a treatment for non-specific cough was not properly studied and there are no studies on the effect of montelukast as prevention for URI. Hypothesis: Prophylactic treatment with Montelukast will reduce the incidence and severity of upper respiratory infection in children.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00551382
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00551382 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assaf-Harofeh Medical Center
- Last refreshed: 16 March 2010
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00551382.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing