This active vs active comparative trial will evaluate the safety and efficacy of incremental doses of atropine in combination with pseudoephedrine 120 mg/chlorpheniramine 8 mg in adult patients with a history of seasonal allergic rhinitis. Hypotheses are defined by total nasal symptom scores (TNSS) recorded by subjects in diaries where efficacy will be established by statistical significance where p \< 0.05.
Actives in each of the five study arms: Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine 0.36 mg Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine 0.24 mg Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine 0.12 mg Pseudoephedrine 120 mg/Chlorpheniramine 8 mg Atropine 0.24 mg
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
125
Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.36 mg white, scored, tablets with "M27" on scored side and plain on the other side
Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.24 mg white, scored, tablets with "M27" on scored side and plain on the other side
Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.12 mg white, scored, tablets with "M27" on scored side and plain on the other side
Clinical Research Atlanta
Stockbridge, Georgia, United States
Family Allergy and Asthma Institute
Louisville, Kentucky, United States
National Allergy, Asthma & Urticaria Centers of Charleston, PA
Charleston, South Carolina, United States
Central Texas Health Research
New Braunfels, Texas, United States
Dose-ranging data for atropin
To provide dose-ranging data for atropine and select a dose of Atropine for Phase 3 clinical development using Total Nasal Symptom Score (TNSS) as the primary endpoint plus recording of adverse events
Time frame: 7.5 days
Establish effect size for determining power and TNSS efficacy endpoint
To establish an effect size of a Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine combination versus Pseudoephedrine 120 mg/Chlorpheniramine 8 mg to statistically power the pivotal phase of the study using TNSS as the primary endpoint
Time frame: 7.5 days
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Pseudoephedrine 120 mg, chlorpheniramine 8 mg tablets dosed BID
Atropine sulfate 0.24 mg white, scored, tablets with "M27" on scored side and plain on the other side