Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure (Study P04295)

Inclusion Criteria:

• Must be ≥6 to ≤65 years of age, of either sex, and of any race, with a diagnosis ofasthma at least 2 years prior to the Screening Visit.

• Must have a history of two or more upper respiratory infection-induced asthmaexacerbations in the past 24 months.

• For participants 6 to 17 years of age, exacerbations for the purpose of theinclusion criteria, will be defined as:

• An increase of four or more puffs of a short-acting beta-agonist (SABA) per dayfor at least 3 consecutive days, or

• An increase of two or more nebulizations of a SABA per day for at least 3consecutive days, or

• Documentation of morning (AM) peak flow drops >20% per day for at least 2consecutive days, or

• Documentation of AM peak flow drops of ≥50% for at least 1 day.

• Must have been on a stable dose of any asthma medication (including immunotherapy) forat least 1 month prior to the Screening Visit.

• Must have a pre-bronchodilator FEV1 ≥50% predicted at the Screening Visit, when allprohibited medications have been withheld for the specified interval.

• If a reversibility test has not been performed within the previous 24 months, aparticipant, ≥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 givewritten informed consent and be able to adhere to dose and visit schedules.

• Must be free of any clinically significant disease, other than asthma, which wouldinterfere with study evaluation.

• Must be in general good health, as confirmed by routine clinical and laboratorytesting. All laboratory tests (Complete Blood Count, blood chemistries, andurinalysis) and elctrocardiograms must be within normal limits or clinicallyacceptable to the investigator/sponsor.

• Female of childbearing potential must be using a medically acceptable, adequate formof birth control.

Exclusion Criteria:

• Had an upper or lower respiratory illness or exhibits signs and/or symptoms of arespiratory illness in the 4 weeks prior to the Screening Visit.

• Received any treatment more recently than the indicated washout period prior toScreening or who must continue to receive treatment that is prohibited.

• Smoker or ex-smoker and has smoked within the previous 5 years of Screening or has hada cumulative smoking history >10 pack years.

• Allergy/sensitivity to the study drug or its excipients.

• Female who is breast-feeding, pregnant, or intends to become pregnant.

• Used any investigational drugs within 30 days of Screening.

• Participating in any other clinical study.

• Part of the staff personnel directly involved with this study.

• Family member of the investigational study staff.