Trial Outcomes & Findings for Study of the Effect of Fluticasone Furoate Nasal Spray on Spring Allergy Eye Symptoms (NCT NCT00891436)

NCT ID: NCT00891436

Last Updated: 2012-12-03

Results Overview

Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: Samples taken at initial visit & 2 week follow-up
• Results posted on: 2012-12-03

Participant Flow

Subjects were recruited during the spring pollen season of 2009 at a large urban medcial center's allergy clinic.

There was no run in period. All 20 participants that enrolled in this study were included in the trial.

Participant milestones

Measure	Fluticasone Furoate Nasal Spray Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks	Placebo Nasal Spray Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Effect of Fluticasone Furoate Nasal Spray on Spring Allergy Eye Symptoms

Baseline characteristics by cohort

Measure	Fluticasone Furoate Nasal Spray n=10 Participants Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks	Placebo Nasal Spray n=10 Participants Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	32 years STANDARD_DEVIATION 7.3 • n=5 Participants	29 years STANDARD_DEVIATION 8.0 • n=7 Participants	30 years STANDARD_DEVIATION 7.6 • 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	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Samples taken at initial visit & 2 week follow-up

Population: Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low.

Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Samples taken at initial visit & 2 week follow-up

Population: All participants had tears measured for histamine.

Tear samples were assayed for histamine by ELISA

Outcome measures

Measure	Fluticasone Furoate Nasal Spray n=10 Participants Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks	Placebo Nasal Spray n=10 Participants Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
Histamine Content in the Tears Was Measured.	5.4 ng/ml Standard Error 0.9	5.1 ng/ml Standard Error 0.6

Adverse Events

Fluticasone Furoate Nasal Spray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Nasal Spray

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

James N. Moy, M.D.

Rush University Medical College

Phone: 312-942-6176

Email: jmoy@rush.edu

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor has the right to review the results prior to publication of the results. But no embargo or time limit was given.
• Publication restrictions are in place

Restriction type: OTHER