Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure (Study P04295)
Condition: Asthma; Common Cold; Picornavirus Infection; Rhinovirus
MeSH terms: Common Cold; Picornaviridae Infections; Asthma
Intervention: Pleconaril; Placebo to Pleconaril
Intervention description: Pleconaril nasal suspension is supplied in a bottle containing 120 actuations. Each actuation contains 1.5 mg of pleconaril.; Placebo nasal suspension
Intervention MeSH terms: Pleconaril
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 311.0
Sex: All
Minimum age: 6 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.

               -  For participants 6 to 17 years of age, exacerbations for the purpose of the
                  inclusion criteria, will be defined as:

               -  An increase of four or more puffs of a short-acting beta-agonist (SABA) per day
                  for at least 3 consecutive days, or

               -  An increase of two or more nebulizations of a SABA per day for at least 3
                  consecutive days, or

               -  Documentation of morning (AM) peak flow drops >20% per day for at least 2
                  consecutive 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) 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:

          -  Had an upper or lower respiratory illness or exhibits signs and/or symptoms of a
             respiratory illness in the 4 weeks prior to the Screening Visit.

          -  Received any treatment more recently than the indicated washout period prior to
             Screening 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 had
             a 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.