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Efficacy and Safety of Nasonex vs. Placebo in Subjects With SAR and Concomitant Asthma (Study P03280)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00070707
Recruitment Status : Terminated (Recruitment challenges.)
First Posted : October 10, 2003
Last Update Posted : March 28, 2017
Sponsor:
Collaborator:
Integrated Therapeutics Group
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
An association between seasonal allergic rhinitis (SAR) and allergic asthma has been established through epidemiologic, pathophysiologic, and therapeutic studies. This study will compare Nasonex Nasal Spray to Placebo in treating the nasal and asthma symptoms experienced by subjects with SAR and concomitant asthma.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Seasonal Asthma Drug: Nasonex Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : April 3, 2003
Primary Completion Date : November 26, 2003
Study Completion Date : November 26, 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Hay Fever
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria:

  • Subject must have at least a two-year history of seasonal allergic rhinitis and of increase asthma symptoms associated with the allergy season under study.
  • FEV 1 70% of predicted at both Screening and Baseline visits.
  • Subject must demonstrate an increase in absolute FEV 1 less then 12%, with an absolute volume increase of at least 200 ml, after reversibility testing at Screening or within the past 12 months.
  • Subjects must be skin test positive (skin prick test with a wheal diameter at least 3mm larger than the diluent control or intradermal testing with the wheal diameter at least 7 mm larger than diluent control) at screening, or within 12 months prior to the screening visit, to a seasonal allergen (which may include seasonal molds) prevalent during the study period.

Exclusion Criteria:

  • Subjects with asthma who require chronic use of inhaled or systemic corticosteroids.
  • Subjects who are morbidly obese (BMI>35)

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00070707     History of Changes
Other Study ID Numbers: P03280
First Posted: October 10, 2003    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Seasonal Allergic Rhinitis
Concomitant Asthma

Additional relevant MeSH terms:
Asthma
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents