Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis

Seasonal Allergic Rhinitis Clinical Trial

Official title:

Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00361439
• Other study ID #: 14757A (P04908)
• Secondary ID: IRB #14757A
• Status: Terminated
• Phase: Phase 4
• First received: August 4, 2006
• Last updated: January 27, 2014
• Start date: August 2006
• Est. completion date: September 2008

Study information

• Verified date: January 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

People with allergies frequently complain of a loss or reduction in the sense of smell.

In this study, the investigators propose to perform a randomized, double blind, placebo controlled parallel study of subjects with nasal allergies and decreased smell to determine the effect of a treatment for allergies on the sense of smell.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

1. Males and females between 18 and 59 years of age.

2. Seasonal allergic rhinitis by clinical history, with symptoms of impaired olfaction.

3. Positive skin or RAST test to allergen.

4. Symptoms of olfactory dysfunction.

5. No significant history of chronic sinusitis.

Exclusion Criteria:

1. Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are breastfeeding.

2. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease).

3. Use of any other investigational agent in the last 30 days.

4. Absence of olfactory or nasal symptoms.

5. Use of medications that may affect olfaction.

6. Medical conditions that may affect olfaction.

7. Smoking.

8. URI at the time of screening.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Mometasone
2 puffs in each nostril once daily of nasal spray
• Placebo
2 puffs in each nostril once daily of nasal spray

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Schering-Plough

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological Findings	Number of eosinophils per high-powered field (HPF) in olfactory biopsy taken after 2 weeks of study treatment (higher values indicate greater inflammation); average of three HPF reported	2 weeks	No
Secondary	Change From Baseline in Total Nasal Symptom Score at 2 Weeks	A decrease in scores between visits signifies an improvement in nasal symptoms. The total nasal symptom score can range from 0 to 27.	baseline and 2 weeks	No
Secondary	Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks	An increase between visits indicates improved nasal airflow.	baseline and 2 weeks	No
Secondary	Change From Baseline in Percentage of Eosinophils at 2 Weeks	A decrease between visits signifies a reduction in inflammation.; Calculated from cytology specimens obtained by lavage.	baseline and 2 weeks	No