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Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure (Study P04295AM2)(COMPLETED)
This study has been completed.
First Received: October 31, 2006   Last Updated: June 22, 2007   History of Changes
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00394914
  Purpose

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 subjects exposed to picornavirus respiratory infections. Subjects will be assigned treatment with pleconaril or placebo nasal spray for 7 days (14 doses). Subjects will be followed for an additional 14 days.


Condition Intervention Phase
Asthma
Common Cold
Picornavirus Infection
Rhinovirus
Drug: Pleconaril
Phase II

MedlinePlus related topics: Asthma Common Cold
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Placebo-Controlled Study of the Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure

Further study details as provided by Schering-Plough:

Estimated Enrollment: 600
Study Start Date: August 2006
  Eligibility

Ages Eligible for Study:   6 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be ³6 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 subjects 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 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 ³50% 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 subject, ³17 years of age, must demonstrate an increase in absolute FEV1 of ³12%, with an absolute volume increase of at least 200 mL. A subject <17 years of age, must demonstrate an increase in absolute FEV1 ³12%.
  • Must cohabit with at least one other person (family member, roommate).
  • A subject (or the subject’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 (CBC, blood chemistries, and urinalysis) and ECGs 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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Study ID Numbers: P04295, Doc ID: 3303796;, SCH 900819
Study First Received: October 31, 2006
Last Updated: June 22, 2007
ClinicalTrials.gov Identifier: NCT00394914     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Bronchial Diseases
Picornaviridae Infections
Asthma
Pleconaril
Antiviral Agents
Virus Diseases
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Common Cold
Lung Diseases
Hypersensitivity, Immediate
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Bronchial Diseases
Immune System Diseases
Pleconaril
Asthma
Picornaviridae Infections
Infection
Antiviral Agents
Pharmacologic Actions
Virus Diseases
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Infections
Respiratory Tract Diseases
Common Cold
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009