Conditions: Asthma Common Cold Picornavirus Infection Rhinovirus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 311
Healthy volunteers: no

Brief summary:
This is a randomized, multi-center, double-blind, placebo-controlled study evaluating the efficacy of pleconaril nasal spray in preventing asthma exacerbation and common cold symptoms in asthmatic participants exposed to picornavirus respiratory infections. Participants will be assigned treatment with pleconaril or placebo nasal spray for 7 days (14 doses). Participants will be followed for an additional 14 days.

Detailed description:

Arms:
arm 1: Participants will receive Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses. arm 2: Participants will receive placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.

Interventions: intervention 1: Pleconaril intervention 2: Placebo to Pleconaril
Intervention descriptions: intervention 1: Pleconaril nasal suspension is supplied in a bottle containing 120 actuations. Each actuation contains 1.5 mg of pleconaril. intervention 2: Placebo nasal suspension

Protocol document: