Trial Outcomes & Findings for Intranasal Steroids and Oxymetazoline in Allergic Rhinitis (NCT NCT00584987)

Results Overview

The severity of nasal congestion was recorded in the morning (reflective of symptoms overnight) and evening (reflective of daytime symptoms) on a 0 to 3 scale. The total nasal congestion symptom score was obtained by adding the symptoms obtained on all 28 days of treatment. Values for this outcome are in the range of 0 to 168 (i.e., 6 x 28). Congestion scores increase with congestion severity (i.e., higher numbers correspond to worse congestion).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

64 participants

Primary outcome timeframe

28 days of treatment

Results posted on

2013-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	PL FF + PL OXY Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + PL OXY Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	PL FF + OXY Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + OXY Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
Overall Study STARTED	15	16	17	16
Overall Study COMPLETED	14	15	16	15
Overall Study NOT COMPLETED	1	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	PL FF + PL OXY Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + PL OXY Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	PL FF + OXY Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + OXY Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
Overall Study Protocol Violation	1	1	1	0
Overall Study Adverse Event	0	0	0	1

Baseline Characteristics

Intranasal Steroids and Oxymetazoline in Allergic Rhinitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo FF + Placebo OXY n=15 Participants Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + Placebo OXY n=16 Participants Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	Placebo FF + OXY n=17 Participants Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + OXY n=16 Participants Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	Total n=64 Participants Total of all reporting groups
Age Continuous	29.6 years STANDARD_DEVIATION 11 • n=5 Participants	31.7 years STANDARD_DEVIATION 9.5 • n=7 Participants	26.6 years STANDARD_DEVIATION 5.2 • n=5 Participants	28.6 years STANDARD_DEVIATION 8.7 • n=4 Participants	28.8 years STANDARD_DEVIATION 8.5 • n=21 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	9 Participants n=4 Participants	41 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	23 Participants n=21 Participants

PRIMARY outcome

Timeframe: 28 days of treatment

The severity of nasal congestion was recorded in the morning (reflective of symptoms overnight) and evening (reflective of daytime symptoms) on a 0 to 3 scale. The total nasal congestion symptom score was obtained by adding the symptoms obtained on all 28 days of treatment. Values for this outcome are in the range of 0 to 168 (i.e., 6 x 28). Congestion scores increase with congestion severity (i.e., higher numbers correspond to worse congestion).

Outcome measures

Outcome measures
Measure	Placebo FF + Placebo OXY n=14 Participants Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + Placebo OXY n=15 Participants Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	Placebo FF + OXY n=16 Participants Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + OXY n=15 Participants Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
Total Nasal Congestion Symptom Score	94 units on a scale Interval 60.0 to 157.0	70 units on a scale Interval 34.0 to 151.0	75 units on a scale Interval 7.0 to 132.0	68 units on a scale Interval 2.0 to 115.0

SECONDARY outcome

Timeframe: assessed at baseline

The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.

Outcome measures

Outcome measures
Measure	Placebo FF + Placebo OXY n=14 Participants Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + Placebo OXY n=15 Participants Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	Placebo FF + OXY n=16 Participants Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + OXY n=15 Participants Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
RQLQ Score [Baseline]	3.07 units on a scale Standard Error 0.28	3.25 units on a scale Standard Error 0.29	2.99 units on a scale Standard Error 0.28	2.60 units on a scale Standard Error 0.22

SECONDARY outcome

Timeframe: assessed 2 weeks after initiation of treatment regimen

The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.

Outcome measures

Outcome measures
Measure	Placebo FF + Placebo OXY n=14 Participants Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + Placebo OXY n=15 Participants Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	Placebo FF + OXY n=16 Participants Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + OXY n=15 Participants Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
RQLQ Score [2 Weeks]	2.20 units on a scale Standard Error 0.26	2.03 units on a scale Standard Error 0.26	2.11 units on a scale Standard Error 0.20	1.62 units on a scale Standard Error 0.24

SECONDARY outcome

Timeframe: assessed 4 weeks after initiation of treatment regimen

The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.

Outcome measures

Outcome measures
Measure	Placebo FF + Placebo OXY n=14 Participants Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + Placebo OXY n=15 Participants Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	Placebo FF + OXY n=16 Participants Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + OXY n=15 Participants Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
RQLQ Score [4 Weeks]	1.75 units on a scale Standard Error 0.24	1.37 units on a scale Standard Error 0.24	1.85 units on a scale Standard Error 0.20	1.26 units on a scale Standard Error 0.22

SECONDARY outcome

Timeframe: assessed 6 weeks after initiation of treatment regimen

The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.

Outcome measures

Outcome measures
Measure	Placebo FF + Placebo OXY n=14 Participants Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + Placebo OXY n=15 Participants Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	Placebo FF + OXY n=16 Participants Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + OXY n=15 Participants Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
RQLQ Score [6 Weeks]	1.85 units on a scale Standard Error 0.25	1.83 units on a scale Standard Error 0.33	2.03 units on a scale Standard Error 0.27	1.55 units on a scale Standard Error 0.19

SECONDARY outcome

Timeframe: days 2 through 28 of the treatment cycle

Nasal peak inspiratory flow (NPIF) is a physiological measure of nasal airflow which is particularly sensitive to nasal valve collapse. NPIF was measured objectively in liters per minute with an In-Check Peak Inspiratory FlowMeter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and recorded the best flow measured. The morning and evening NPIF measurements were summed for days 2 through 28 of the treatment cycle, yielding the total NPIF outcome measure. NPIF scores increase with air flow quality (i.e., higher NPIF values are indicative of better nasal air flow).

Outcome measures

Outcome measures
Measure	Placebo FF + Placebo OXY n=14 Participants Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + Placebo OXY n=15 Participants Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	Placebo FF + OXY n=16 Participants Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + OXY n=15 Participants Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
Total NPIF	5240 liters per minute Interval 2370.0 to 9085.0	5680 liters per minute Interval 3890.0 to 9715.0	4485.5 liters per minute Interval 3270.0 to 7840.0	5520 liters per minute Interval 3322.0 to 10280.0

Adverse Events

Placebo FF + Placebo OXY

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

FF + Placebo OXY

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo FF + OXY

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

FF + OXY

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo FF + Placebo OXY n=15 participants at risk Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + Placebo OXY n=16 participants at risk Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	Placebo FF + OXY n=17 participants at risk Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	FF + OXY n=16 participants at risk Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
General disorders Headaches	13.3% 2/15 • Subjects were monitored for adverse events 2 weeks after treatment as outlined in the protocol. No subjects presented with adverse events after the official follow-up period concluded.	25.0% 4/16 • Subjects were monitored for adverse events 2 weeks after treatment as outlined in the protocol. No subjects presented with adverse events after the official follow-up period concluded.	11.8% 2/17 • Subjects were monitored for adverse events 2 weeks after treatment as outlined in the protocol. No subjects presented with adverse events after the official follow-up period concluded.	12.5% 2/16 • Subjects were monitored for adverse events 2 weeks after treatment as outlined in the protocol. No subjects presented with adverse events after the official follow-up period concluded.

Additional Information

Dr. Robert M. Naclerio, MD

The University of Chicago

Phone: (773) 702-1865

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place