Trial Outcomes & Findings for Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen (NCT NCT00791973)

NCT ID: NCT00791973

Last Updated: 2014-07-08

Results Overview

Tryptase levels (mcg/L) were measured from nasal lavages

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: After one week of treatment wtih veramyst or placebo
• Results posted on: 2014-07-08

Participant Flow

24 subjects were screened for eligibility

15 of the 24 subjects screened were eligible for the study and were randomly assigned to groups

Participant milestones

Measure	Veramyst, Then Placebo fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week, then one week washout period followed by placebo nasal spray once daily , 2 puffs/nostril, for a week	Placebo, Then Veramyst placebo nasal spray once daily (2 puffs/nostril) for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily (2 puffs/nostril) for a week
First Intervention (1 Week) STARTED	8	7
First Intervention (1 Week) COMPLETED	8	7
First Intervention (1 Week) NOT COMPLETED	0	0
Washout (1 Week) STARTED	8	7
Washout (1 Week) COMPLETED	8	7
Washout (1 Week) NOT COMPLETED	0	0
Second Intervention (1 Week) STARTED	8	7
Second Intervention (1 Week) COMPLETED	8	7
Second Intervention (1 Week) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen

Baseline characteristics by cohort

Measure	Veramyst, Then Placbeo n=8 Participants fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week, then one week washout period followed by placebo nasal spray once daily , 2 puffs/nostril, for a week	Placebo, Then Veramyst n=7 Participants placebo nasal spray once daily (2 puffs/nostril) for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily (2 puffs/nostril) for a week	Total n=15 Participants Total of all reporting groups
Age, Continuous	32 years STANDARD_DEVIATION 11 • n=5 Participants	29 years STANDARD_DEVIATION 6 • n=7 Participants	30 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	7 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: After one week of treatment wtih veramyst or placebo

Tryptase levels (mcg/L) were measured from nasal lavages

Outcome measures

Measure	Veramyst n=15 Participants fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week	Placebo n=15 Participants placebo nasal spray once daily (2 puffs/nostril) for a week
Change in Tryptase Level From Baseline to Post-antigen Challenge	0 mcg/L Interval 0.0 to 11.8	2.31 mcg/L Interval 0.0 to 8.8

SECONDARY outcome

Timeframe: After one week of treatment wtih veramyst or placebo

Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe

Outcome measures

Measure	Veramyst n=15 Participants fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week	Placebo n=15 Participants placebo nasal spray once daily (2 puffs/nostril) for a week
Total Eye Symptom Scores After Antigen Challenge	3 units on a scale Interval 0.0 to 4.0	3 units on a scale Interval 1.0 to 9.0

Adverse Events

Veramyst

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

Dr. Robert Naclerio

University of Chicago

Phone: (773) 702-0080

Email: rnacleri@surgery.bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place