Trial Outcomes & Findings for Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis (NCT NCT00361439)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

2 weeks

Results posted on

2014-02-28

Participant Flow

Subjects were enrolled during relevant allergy seasons in Chicago, IL, from 2006 to 2008.

Participant milestones

Participant milestones
Measure	Mometasone Active intranasal steroid therapy daily for 2 weeks	Placebo 2 puffs of placebo spray once daily
Overall Study STARTED	8	9
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mometasone n=8 Participants Active intranasal steroid therapy daily for 2 weeks	Placebo n=9 Participants 2 puffs of placebo spray once daily	Total n=17 Participants Total of all reporting groups
Age, Continuous	40 years n=5 Participants	38 years n=7 Participants	39 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants
Allergen sensitivity Ragweed	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
Allergen sensitivity Grass	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Outcome measures
Measure	Mometasone n=8 Participants Active intranasal steroid therapy daily for 2 weeks	Placebo n=9 Participants 2 puffs of placebo spray once daily
Histological Findings	0.167 eosinophils per HPF Interval 0.0 to 1.33	2.67 eosinophils per HPF Interval 1.33 to 11.0

SECONDARY outcome

Timeframe: baseline and 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.

Outcome measures

Outcome measures
Measure	Mometasone n=8 Participants Active intranasal steroid therapy daily for 2 weeks	Placebo n=9 Participants 2 puffs of placebo spray once daily
Change From Baseline in Total Nasal Symptom Score at 2 Weeks	-12 units on a scale Interval -18.0 to -2.0	-5 units on a scale Interval -13.0 to 13.0

SECONDARY outcome

Timeframe: baseline and 2 weeks

An increase between visits indicates improved nasal airflow.

Outcome measures

Outcome measures
Measure	Mometasone n=8 Participants Active intranasal steroid therapy daily for 2 weeks	Placebo n=9 Participants 2 puffs of placebo spray once daily
Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks	19.2 liters per minute Interval -3.3 to 56.7	-37.5 liters per minute Interval -58.0 to 5.0

SECONDARY outcome

Timeframe: baseline and 2 weeks

A decrease between visits signifies a reduction in inflammation. Calculated from cytology specimens obtained by lavage.

Outcome measures

Outcome measures
Measure	Mometasone n=8 Participants Active intranasal steroid therapy daily for 2 weeks	Placebo n=9 Participants 2 puffs of placebo spray once daily
Change From Baseline in Percentage of Eosinophils at 2 Weeks	-1.35 percentage of eosinophils Interval -12.9 to 4.2	-0.1 percentage of eosinophils Interval -53.9 to 0.8

Adverse Events

Mometasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jayant Pinto, MD

University of Chicago

Phone: 773-702-6727

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place