Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT02630121
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Oxymetazoline Hydrochloride — DRUG
    Proportion of the subjects with 50% reduction in AHI.
  • Placebo — DRUG
    Proportion of the subjects with 50% reduction in AHI.

Study Details

The addition of intranasal oxymetazoline for two weeks to already instituted optimal doses of intranasal fluticasone propionate will decrease the total number of obstructive apneas and hypopneas per hour of sleep in subjects with perennial allergic or non-allergic rhinitis and mild obstructive sleep apnea who have persistent nasal congestion despite maximum doses of NGCS.

Key Dates

Start date
Apr 1, 2023
Status verified
Jan 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo/Fluticasone Propionate
    Placebo Spray 2 Sprays QHS Fluticasone Propionate 1 spray BID
  • Active Comparator: Oxymetazoline Hydrochloride /Fluticasone Propionate
    Oxymetazoline Hydrochloride 2 Sprays QHS Fluticasone Propionate 1 spray BID

Primary Outcome Measure

The proportion of subjects demonstrating a 50% reduction in the apnea hypopnea index after treatment with oxymetazoline hydrochloride and fluticasone propionate for 2 weeks. [ Time Frame: 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Usf Asthma Allergy and Immunology CruTampaFlorida33613
Catherine Smith
[email protected]
813-631-4024
RICHARD F LOCKEY, MD (PRINCIPAL_INVESTIGATOR)
DENNIS K LEDFORD, MD (SUB_INVESTIGATOR)
ROGER W FOX, MD (SUB_INVESTIGATOR)
MARK C GLAUM, MD (SUB_INVESTIGATOR)

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