Efficacy and Safety of Nasonex vs. Placebo in Subjects With SAR and Concomitant Asthma (Study P03280)
This study has been terminated.
First Posted: October 10, 2003
Last Update Posted: March 28, 2017
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.
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Integrated Therapeutics Group
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
Rhinitis, Allergic, Seasonal
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
| Actual Study Start Date:
||April 3, 2003
| Study Completion Date:
||November 26, 2003
| Primary Completion Date:
||November 26, 2003 (Final data collection date for primary outcome measure)
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:
|Accepts Healthy Volunteers:
- 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.
- Subjects with asthma who require chronic use of inhaled or systemic corticosteroids.
- Subjects who are morbidly obese (BMI>35)
No Contacts or Locations Provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
||October 7, 2003
||October 10, 2003
|Last Update Posted:
||March 28, 2017
Keywords provided by Merck Sharp & Dohme Corp.:
Seasonal Allergic Rhinitis
Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Infections