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

This study has been terminated.
(Recruitment challenges.)
Sponsor:
Collaborator:
Integrated Therapeutics Group
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00070707
First received: October 7, 2003
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Rhinitis, Allergic, Seasonal
Asthma
Drug: Nasonex
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Enrollment: 188
Study Start Date: April 2003
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00070707     History of Changes
Other Study ID Numbers: P03280
Study First Received: October 7, 2003
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 18, 2014