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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.
Enrollment
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Inclusion criteria
Must be ≥6 to ≤65 years of age, of either sex, and of any race, with a diagnosis of asthma at least 2 years prior to the Screening Visit.
Must have a history of two or more upper respiratory infection-induced asthma exacerbations in the past 24 months.
Must have been on a stable dose of any asthma medication (including immunotherapy) for at least 1 month prior to the Screening Visit.
Must have a pre-bronchodilator FEV1 ≥50% predicted at the Screening Visit, when all prohibited medications have been withheld for the specified interval.
If a reversibility test has not been performed within the previous 24 months, a participant, ≥17 years of age, must demonstrate an increase in absolute FEV1 of ≥12%, with an absolute volume increase of at least 200 mL. A participant <17 years of age, must demonstrate an increase in absolute FEV1 ≥12%.
Must cohabit with at least one other person (family member, roommate).
A participant (or the participant's legal representation) must be willing to give written informed consent and be able to adhere to dose and visit schedules.
Must be free of any clinically significant disease, other than asthma, which would interfere with study evaluation.
Must be in general good health, as confirmed by routine clinical and laboratory testing. All laboratory tests (Complete Blood Count, blood chemistries, and urinalysis) and elctrocardiograms must be within normal limits or clinically acceptable to the investigator/sponsor.
Female of childbearing potential must be using a medically acceptable, adequate form of birth control.
Exclusion criteria
Primary purpose
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Interventional model
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311 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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