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NCT02630121 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Sleep Apnea and Chronic Nasal Congestion, sponsored by University of South Florida.

Recruiting
Registry status
Phase 4
Development phase
52
Enrollment target
1
Study location

NCT02630121: Recruiting Phase 4 study of Sleep Apnea and Chronic Nasal Congestion, sponsored by University of South Florida.

NCT02630121 is a Phase 4 study of Sleep Apnea and Chronic Nasal Congestion that is actively recruiting participants, run by University of South Florida. The registered enrollment target is 52 participants, below the 2,988-participant average among 36 other Sleep Apnea trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02630121, a Phase 4 study of Sleep Apnea and Chronic Nasal Congestion, is actively recruiting participants, sponsored by University of South Florida.

RECRUITING
Registry status
Phase 4
Development phase
52 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

This study is a double blinded, placebo control, cross over prospective trial. Each subject will complete the two arms in this study. The subject will be randomized to receive either oxymetazoline hydrochloride plus fluticasone propionate initially or placebo plus fluticasone propionate and complete treatment for a total of 2 weeks respectively. At the completion of each arm (prior to visit 3 and visit 5), the apnea hypopnea index will be measured.

Interventions

  • DRUG Placebo
  • DRUG Oxymetazoline Hydrochloride

Study Locations (1)

Florida

  • Usf Asthma Allergy and Immunology Cru - Tampa

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2023-04-01
Est. Completion 2026-04
Phase Phase 4
University of South Florida

252 total trials

What NCT02630121 shows while recruiting

NCT02630121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 2,988-participant average among 36 other Sleep Apnea trials with a reported enrollment target (98% lower).

The record links to 2 conditions, with Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02630121 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT02630121 about?

NCT02630121 is a clinical study titled "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". 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...

What is the current status of trial NCT02630121?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 52 participants. The study started on 2023-04-01. Estimated completion is 2026-04.

What conditions does trial NCT02630121 study?

This clinical trial studies the following conditions: Sleep Apnea, Chronic Nasal Congestion.

What interventions are being tested in trial NCT02630121?

The interventions under investigation include: Placebo (DRUG), Oxymetazoline Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT02630121?

This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02630121 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Sleep Apnea

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02630121's enrollment target sits among peer trials

52 26th of 36 higher than 11 of 36 other Sleep Apnea trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02630121, the US trial registry maintained by the National Library of Medicine. NCT02630121 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.