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

NCT00394914 | Completed Phase 2 Results

• 2 other identifiers: P04295Doc ID: 3303796
• Study Type: interventional
• Target: 311
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (8)

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

  Baseline through the Final Visit (Day 21)

• LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

  Baseline through the Final Visit (Day 21)

• LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM

  Baseline through the Final Visit (Day 21)

• LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM

  Baseline through the Final Visit (Day 21)

• LS Mean Change From Baseline in Total Cold Symptom Score

  Baseline through the Final Visit (Day 21)

Study Arms (2)

Pleconaril

EXPERIMENTAL

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.

Drug: Pleconaril

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo to Pleconaril

Interventions

Pleconaril DRUG

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

Also known as: SCH 900819

Pleconaril

Placebo to Pleconaril DRUG

Placebo nasal suspension

Placebo

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Asthma; Common Cold; Picornaviridae Infections

Interventions

pleconaril

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2006
• First Posted: November 2, 2006
• Study Start: August 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: July 16, 2015
• Results First Posted: October 31, 2013

Record last verified: 2015-06