Trial · NCT00584987

Intranasal Steroids and Oxymetazoline in Allergic Rhinitis

NCT00584987, Phase 4, Completed, University of Chicago; results first posted 2013-12-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Intranasal Steroids and Oxymetazoline in Allergic Rhinitis. Trials, record NCT00584987. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00584987

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Intranasal Steroids and Oxymetazoline in Allergic Rhinitis
NCT number: NCT00584987
Status: Completed
Phases: Phase 4
Enrollment: 64 participants, actual
Lead sponsor: University of Chicago
Conditions: Allergic Rhinitis
Interventions: Fluticasone furoate, Placebo Fluticasone furoate, Oxymetazoline, Placebo Oxymetazoline
First posted: 2008-01-02
Last updated: 2013-12-17
Results first posted: 2013-12-17

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Total Nasal Congestion Symptom Score	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).
Secondary	RQLQ Score [Baseline]	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.
Secondary	RQLQ Score [2 Weeks]	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.
Secondary	RQLQ Score [4 Weeks]	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.
Secondary	RQLQ Score [6 Weeks]	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.
Secondary	Total NPIF	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).

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Total Nasal Congestion Symptom Score	28 days of treatment	units on a scale	MEDIAN
SECONDARY	RQLQ Score [Baseline]	assessed at baseline	units on a scale	MEAN
SECONDARY	RQLQ Score [2 Weeks]	assessed 2 weeks after initiation of treatment regimen	units on a scale	MEAN
SECONDARY	RQLQ Score [4 Weeks]	assessed 4 weeks after initiation of treatment regimen	units on a scale	MEAN
SECONDARY	RQLQ Score [6 Weeks]	assessed 6 weeks after initiation of treatment regimen	units on a scale	MEAN
SECONDARY	Total NPIF	days 2 through 28 of the treatment cycle	liters per minute	MEDIAN

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Total Nasal Congestion Symptom Score	Placebo FF + Placebo OXY	94	Full Range 60 to 157	units on a scale
Total Nasal Congestion Symptom Score	FF + Placebo OXY	70	Full Range 34 to 151	units on a scale
Total Nasal Congestion Symptom Score	Placebo FF + OXY	75	Full Range 7 to 132	units on a scale
Total Nasal Congestion Symptom Score	FF + OXY	68	Full Range 2 to 115	units on a scale
RQLQ Score [Baseline]	Placebo FF + Placebo OXY	3.07	Standard Error 0.28	units on a scale
RQLQ Score [Baseline]	FF + Placebo OXY	3.25	Standard Error 0.29	units on a scale
RQLQ Score [Baseline]	Placebo FF + OXY	2.99	Standard Error 0.28	units on a scale
RQLQ Score [Baseline]	FF + OXY	2.60	Standard Error 0.22	units on a scale
RQLQ Score [2 Weeks]	Placebo FF + Placebo OXY	2.20	Standard Error 0.26	units on a scale
RQLQ Score [2 Weeks]	FF + Placebo OXY	2.03	Standard Error 0.26	units on a scale

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PL FF + PL OXY	15
Overall Study	STARTED	FF + PL OXY	16
Overall Study	STARTED	PL FF + OXY	17
Overall Study	STARTED	FF + OXY	16
Overall Study	COMPLETED	PL FF + PL OXY	14
Overall Study	COMPLETED	FF + PL OXY	15
Overall Study	COMPLETED	PL FF + OXY	16
Overall Study	COMPLETED	FF + OXY	15
Overall Study	NOT COMPLETED	PL FF + PL OXY	1
Overall Study	NOT COMPLETED	FF + PL OXY	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events4

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headaches	General disorders	Placebo FF + Placebo OXY	2	15
other	Headaches	General disorders	FF + Placebo OXY	4	16
other	Headaches	General disorders	Placebo FF + OXY	2	17
other	Headaches	General disorders	FF + OXY	2	16

Source ClinicalTrials.gov

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo FF + Placebo OXY
Total, all-cause mortality	FF + Placebo OXY
Total, all-cause mortality	Placebo FF + OXY
Total, all-cause mortality	FF + OXY
Total, other adverse events	Placebo FF + Placebo OXY	2	15
Total, other adverse events	FF + Placebo OXY	4	16
Total, other adverse events	Placebo FF + OXY	2	17
Total, other adverse events	FF + OXY	2	16
Total, serious adverse events	Placebo FF + Placebo OXY	0	15
Total, serious adverse events	FF + Placebo OXY	0	16

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21377716	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00584987

GET https://conductscience.org/api/trials/v1/NCT00584987/results?page=2

API reference For AI assistants