Flunisolide Nasal Inhalation |
Nasarel; Nasolide (Removed from Market) |
Clinical Trial: Safety Study To Assess Growth In Pre-Pubertal Children Treated With An Investigational Nasal Spray For Allergic Rhinitis
This study is currently recruiting patients.
|
Purpose
The primary objective of the study is to determine any effect on growth following use of a nasal spray treatment versus a placebo nasal spray in children with seasonal allergic rhinitis (SAR) and/or perennial allergic rhinitis (PAR).
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Hayfever Allergic Rhinitis Seasonal rhinitis Perennial Rhinitis Non-Seasonal rhinitis | Drug: Investigational nasal spray for allergic rhinitis | Phase III |
MedlinePlus related topics: Allergy; Common Cold; Nose Disorders; Respiratory Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
Eligibility
Ages Eligible for Study: 6 Years - 12 Years, Genders Eligible for Study: Both
Criteria
Inclusion criteria:
- Pre-menarcheal female subjects (ages 6 to 11).
- Male subjects (ages 6 to 12)
- Tanner Stage 1
- History of SAR (Seasonal Allergic Rhinitis) or PAR (Perennial Allergic Rhinitis) of at least one year with either a current level of allergic rhinitis symptoms that warrants treatment and/or expected symptoms during a majority of the study period.
- Positive skin test to an appropriate seasonal or perennial allergen.
Exclusion criteria:
- History of abnormal growth or gross malnutrition.
- clinically significant laboratory abnormality.
- History of any condition that may have substantially affected growth.
- Historical or current evidence of clinically significant, uncontrolled disease of any body system.
- Any asthma other than mild, intermittent asthma controlled by short-acting, beta-agonists.
- Recent major surgery and/or trauma to the legs.
- History of adrenal insufficiency.
- Current or prior treatment with any medication that may have a potential for an ongoing effect on linear growth.
- Use of corticosteroids, by any route, within 4 weeks prior to Visit 1.
- Any nasal condition or deformity that would impair nasal breathing or deposition of medication.
- Physical impairment that would affect the subject's ability to participate in the study.
Location and Contact Information
Denmark
Randers, Denmark; Recruiting
More Information
Record last reviewed: April 2005
Last Updated: April 28, 2005
Record first received: April 28, 2005
ClinicalTrials.gov Identifier: NCT00109486
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-03
Source: ClinicalTrials.gov
Cache Date: May 4, 2005
Resources
- Flunisolide Nasal Inhalation (Drug Digest)
- Nasarel (Drug Digest)

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