Upper Respiratory Infection Clinical Trial
Official title:
A Pilot Study to Evaluate the Potential of Montelukast to Prevent the Development of Nasal Symptomatology During Natural Viral Upper Respiratory Infections
NCT number | NCT00189475 |
Other study ID # | RC - 3559 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | October 2003 |
Est. completion date | July 2007 |
Verified date | October 2020 |
Source | West Penn Allegheny Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years.
Status | Completed |
Enrollment | 84 |
Est. completion date | July 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Adults 18 to 50 years of age. - Male or female, who are not pregnant or lactating. - Common cold symptoms for less than 24 hours. - At least 2 of the following 9 symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratch throat, sneezing and malaise. Exclusion Criteria: - Investigational medication in past 30 days. - Known hypersensitivity to any ingredients in study medication. - History of asthma or other chronic diseases. - Females of childbearing potential who are not using a medically acceptable form of birth control. - Patients with nasal ulcers within the past 1 month, nasal surgery within the past 6 months, nasal trauma within the past 2 months or presence of nasal polyps or nasal deformities causing significant nasal obstruction. - Females with a positive urinary HCG test. - Patients with a positive rapid antigen test for streptococcal infection. - Common cold symptoms for more than 24 hours. - Patients who are users of illicit drugs. - Patients who are on rifampin or phenobarbital. |
Country | Name | City | State |
---|---|---|---|
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Deborah Gentile | Merck Sharp & Dohme Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nasal Secretion Weights | 6 days after naturally acquiring an upper respiratory infection |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03711292 -
Using Behavioral Science to Reduce Inappropriate Antibiotic Use in Acute Care Settings
|
N/A | |
Completed |
NCT01168778 -
Improving Communication During Pediatric Visits for Acute Respiratory Illness
|
N/A | |
Terminated |
NCT00187785 -
Doctor-Patient Communication in Spanish
|
N/A | |
Completed |
NCT00405509 -
The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years
|
N/A | |
Completed |
NCT04468204 -
Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI)
|
N/A | |
Active, not recruiting |
NCT05666752 -
Effect of Intake of Allium Cepa L. Peel Heated Water Extract on Immunity Enhancement
|
N/A | |
Completed |
NCT00255307 -
Pilot Evaluation of CVT-E002 in Pediatric Upper Respiratory Tract Infection.
|
Phase 2 | |
Suspended |
NCT05035420 -
A Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of Infectious Respiratory Diseases
|
N/A | |
Recruiting |
NCT06244615 -
Clinical Trial of a Mouth and Throat Rinse for the Treatment of Acute Sore Throat
|
N/A | |
Completed |
NCT02694679 -
Randomized Controlled Trial of Social Network Targeting in Honduras
|
N/A | |
Completed |
NCT05352581 -
BD Veritorâ„¢ At-Home and BD Veritorâ„¢ Professional
|
||
Active, not recruiting |
NCT02943551 -
Dialogue Around Respiratory Illness Treatment
|
N/A | |
Completed |
NCT02110732 -
Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil
|
N/A | |
Completed |
NCT01657643 -
Effect of Probiotics on Health-related Quality of Life in College Students With Upper Respiratory Infections
|
N/A | |
Completed |
NCT00694421 -
Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 2
|
N/A | |
Completed |
NCT03884777 -
Incidence and Risk of Influenza in Myasthenic Patients
|
||
Completed |
NCT00796315 -
Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children
|
Phase 1 | |
Completed |
NCT00642681 -
Effects of URI on Diabetic Subjects Utilizing Technosphere Insulin After a Meal Challenge
|
Phase 2 | |
Completed |
NCT00259831 -
Efficacy of Cold-FX (CVT-E002) in the Prevention of Upper Respiratory Tract Infections in Healthy Adults
|
Phase 3 | |
Completed |
NCT04588376 -
Improving Antibiotic Prescribing for Pediatric Respiratory Infections by Family Physicians With Peer Comparison
|
N/A |