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

NCT ID: NCT00394914

Last Updated: 2015-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2007-04-30

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.

Conditions

Asthma; Common Cold; Picornavirus Infection; Rhinovirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Pleconaril

Participants will receive Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.

Group Type: EXPERIMENTAL

Pleconaril

Intervention Type: DRUG

Pleconaril nasal suspension is supplied in a bottle containing 120 actuations. Each actuation contains 1.5 mg of pleconaril.

Placebo

Participants will receive placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.

Group Type: PLACEBO_COMPARATOR

Placebo to Pleconaril

Intervention Type: DRUG

Placebo nasal suspension

Interventions

Pleconaril

Pleconaril nasal suspension is supplied in a bottle containing 120 actuations. Each actuation contains 1.5 mg of pleconaril.

Intervention Type: DRUG

Placebo to Pleconaril

Placebo nasal suspension

Intervention Type: DRUG

Other Intervention Names

SCH 900819

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.

• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Doc ID: 3303796

Identifier Type: -

Identifier Source: secondary_id

P04295

Identifier Type: -

Identifier Source: org_study_id