Clinical trial NCT00394914: Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure (Study P04295)
Official title: A Placebo-Controlled Study of the Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Common Cold
Picornavirus Infection
Rhinovirus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-11-02
Enrollment: 311
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Percentage of Participants With Rhinovirus PCR-Positive Colds
timeFrame: From time of exposure to index case to end of Follow-up Period (21 days)
measure: Percentage of Participants With Asthma Exacerbations Together With Rhinovirus-Positive PCR
timeFrame: From time of exposure to index case to end of Follow-up Period (21 days)
Secondary outcomes:
measure: LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ)
timeFrame: Baseline through the Final Visit (Day 21)
measure: LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline through the Final Visit (Day 21)
measure: LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
timeFrame: Baseline through the Final Visit (Day 21)
measure: LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
timeFrame: Baseline through the Final Visit (Day 21)
measure: LS Mean Change From Baseline in Total Cold Symptom Score
timeFrame: Baseline through the Final Visit (Day 21)
measure: LS Mean Change From Baseline in Total Asthma Symptom Score
timeFrame: Baseline through the Final Visit (Day 21)
measure: LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
timeFrame: Baseline through the Final Visit (Day 21)
measure: LS Mean Change From Baseline in Asthma-Related Sleep Interference
timeFrame: Baseline through the Final Visit (Day 21)
Other outcomes:
Locations:
Study officials:
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