Phase 4
N=64
Intranasal Steroids and Oxymetazoline in Allergic Rhinitis
Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00584987 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Total Nasal Congestion Symptom Score — 94; 70; 75; 68 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fluticasone furoate (Drug); Placebo Fluticasone furoate (Drug); Oxymetazoline (Drug); Placebo Oxymetazoline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Nasal Congestion Symptom Score |
94; 70; 75; 68 | — |
| SECONDARY RQLQ Score [Baseline] |
3.07; 3.25; 2.99; 2.60 | — |
| SECONDARY RQLQ Score [2 Weeks] |
2.20; 2.03; 2.11; 1.62 | — |
| SECONDARY RQLQ Score [4 Weeks] |
1.75; 1.37; 1.85; 1.26 | — |
| SECONDARY RQLQ Score [6 Weeks] |
1.85; 1.83; 2.03; 1.55 | — |
| SECONDARY Total NPIF |
5240; 5680; 4485.5; 5520 | — |
Summary
We hypothesize that once daily use of oxymetazoline will not cause significant rhinitis medicamentosa and that the combination of fluticasone furoate plus oxymetazoline leads to faster relief of nasal congestion secondary to perennial allergic rhinitis than the use of fluticasone furoate alone.
Eligibility Criteria
Inclusion Criteria
- Males and females between 18 and 55 years of age.
- History of perennial allergic rhinitis.
- Positive skin test to dust mite, dog, cat or indoor mold antigen.
- And a combined nasal morning and evening score of ≥4 for nasal congestion in the day preceding entry
Exclusion Criteria
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Subjects treated with systemic steroids during the previous 30 days.
- Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days.
- Subjects treated with oral antihistamine/decongestants during the previous seven days.
- Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days.
- Subjects treated with immunotherapy and are escalating their dose.
- Subjects on chronic anti-asthma medications.
- Subjects with polyps in the nose or a significantly displaced septum.
- Upper respiratory infection within 14 days of study start.
Data sourced from ClinicalTrials.gov (NCT00584987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.