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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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 24, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Apr 2024 to Apr 2026
    • Start date changed from estimate of Apr 2023 to Apr 1, 2023
    v10
  2. Start date: Jan 2022 to Apr 2023v9
  3. Start date: Jul 2021 to Jan 2022v8
  4. Primary completion date: Apr 2020 to Apr 2024
    • Start date: Jun 3, 2019 to Jul 2021
    • Study completion date: Aug 2020 to Apr 2024
    v7
  5. Start date: Dec 2018 to Jun 3, 2019v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Nov 2018 to Dec 2018
    • Site contact updated
    • Study title revised
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Apr 2017 to Apr 2020
    • Start date: Nov 2016 to Nov 2018
    • Study completion date: Aug 2017 to Aug 2020
    v4
  3. Start date: Feb 2016 to Nov 2016v3
  4. Study title revisedv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02630121
Lead Sponsor University of South Florida
Conditions
(from sponsor)		 Sleep Apnea, Chronic Nasal Congestion
Related terms Sleep Apnea Syndromes
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov