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

Merck Sharp & Dohme LLC311 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

311

Conditions

Asthma Common Cold Picornavirus Infection Rhinovirus

Interventions

Eligibility

Sex: ALLMin age: 6 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percentage of Participants With Rhinovirus PCR-Positive Colds

The common cold was defined as moderate or severe rhinorrhea and at least one other cold symptom of moderate to severe intensity for at least 1 day, together with rhinovirus-positive polymerase chain reaction (PCR), after a participant had temporal exposure to an index case. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.

Time frame: From time of exposure to index case to end of Follow-up Period (21 days)

Percentage of Participants With Asthma Exacerbations Together With Rhinovirus-Positive PCR

Asthma exacerbation was defined as a participant having one of the following: 1. 0.5 point or more increase in the Asthma Control Questionnaire (ACQ) from Baseline at Day 7. The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ. 2. Any change to asthma treatment as prescribed by a physician, unscheduled contact (either office visit or phone contact where medication was changed for asthma symptoms), emergency room visit, or hospitalization. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.

Time frame: From time of exposure to index case to end of Follow-up Period (21 days)

Secondary Outcomes

LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ)

The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ. Pooled standard deviations (SDs) and least square (LS) means were calculated based on an analysis of variates (ANOVA) model.