Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)
Status and phase
Completed
Phase 3
Conditions
Seasonal Allergic Rhinitis
Treatments
Drug: Comparator: placebo
Drug: Comparator: montelukast/loratadine
Drug: Comparator: loratadine
Drug: Comparator: montelukast
Details and patient eligibility
About
This study will evaluate the ability of oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and placebo.
Enrollment
907 patients
Sex
All
Ages
15 to 85 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Patient has a documented history of seasonal allergic rhinitis symptoms that flare up during the study season
- Patient is a nonsmoker
- Patient is in good general health
Exclusion criteria
- Patient is hospitalized
- Patient is a woman who is less than 8 weeks postpartum or is breast-feeding
- Patient intends to move or vacation away during the study
- Patient has had any major surgery within 4 weeks of study start
- Patient is a current or past abuser of alcohol or illicit drugs
- Patient has been treated in an emergency room for asthma in the past month
- Patient had an upper respiratory infection with in 3 weeks prior to study start
- Patient has any active pulmonary disorder other than asthma
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
907 participants in 4 patient groups, including a placebo group
1
Experimental group
Description:
montelukast/loratadine
Treatment:
Drug: Comparator: montelukast/loratadine
2
Experimental group
Description:
loratadine
Treatment:
Drug: Comparator: loratadine
3
Experimental group
Description:
montelukast
Treatment:
Drug: Comparator: montelukast
4
Placebo Comparator group
Description:
placebo
Treatment:
Drug: Comparator: placebo
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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