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

  • STATUS
    Recruiting
  • End date
    Apr 9, 2024
  • participants needed
    52
  • sponsor
    University of South Florida
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Updated on 14 February 2022
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obstructive sleep apnea
apnea-hypopnea index

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.

Description

To evaluate the effectiveness of the addition of intranasal oxymetazoline to ongoing optimal doses of intranasal fluticasone propionate on the apnea/hypopnea index (AHI) in subjects with persistent nasal congestion and mild obstructive sleep apnea secondary to perennial allergic or non-allergic rhinitis despite treatment with the recommended doses of NGCS. The NOX T3 portable sleep monitor will be used to measure the AHI.

  1. The Flow Sensor, as part of the NOX T3 portable monitor, will be used to assess flow limitation of the upper airway through calculation of the flattening index, a marker of upper airway resistance.
  2. The Congestion Quantifier 7 (CQ7) questionnaire will be used to assess for an improvement in nasal congestion based on symptoms from the prior week.
  3. The Nasal Congestion Visual Analog Scale (VAS) will be used to identify the changes in the severity of nasal congestion on a day to day basis.
  4. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) will be used to assess the impact of perennial rhinitis and nasal congestion on activities of daily living.

Details
Condition Sleep Apnea, Chronic Nasal Congestion
Treatment Placebo, Oxymetazoline Hydrochloride
Clinical Study IdentifierNCT02630121
SponsorUniversity of South Florida
Last Modified on14 February 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male and female subjects 18 - 65 years of age
At least a one year history of perennial allergic or non-allergic rhinitis
Subjects must be on the maximum recommended doses of one of the following NGCS for at least one month. (See Table I)
AHI per hour of sleep > 5 and <15, minimum SpO2 88, indicating mild obstructive sleep apnea)
Average Nasal Congestion VAS of > 3-10 indicating moderate to severe nasal congestion between visits 1 and 2 based on daily symptoms (average of 7 scores)
Average Congestion Quantifier 7 score of 7 between visits 1 and 2 based on weekly symptoms (average of 2 scores)
Willingness to participate as indicated by signed informed consent

Exclusion Criteria

Presence of hypersensitivity to oxymetazoline or fluticasone propionate
Subjects receiving allergen immunotherapy but not on a stable maintenance regimen for at least 30 days before the first study visit
If the subject has perennial allergic rhinitis, he/she should not be entered into this study eight weeks before, during, or six weeks after any seasonal exacerbation
Women who are pregnant or lactating
Other known nasal diseases likely to affect deposition of oxymetazoline such as sinusitis, nasal polyps, or major nasal structural malformations
Respiratory tract infections in the last 14 days
Infections requiring antibiotics in the last 14 days
Asthma or chronic obstructive pulmonary disease (COPD) requiring roflumilast or more than the recommended doses of inhaled corticosteroids, beta agonists, or antimuscarinic agents
No systemic glucocorticosteroids for one month prior or during the study
Cardiovascular disease with uncontrolled hypertension (BP160/80), arrhythmias and/or congestive heart failure
Insulin-dependent diabetes mellitus and/or diabetic retinopathy
Subjects with mild OSA (AHI 5-14) and SpO2 <88 for > 5 min during sleep that is identified during the screening portable sleep study
Hypertension requiring more than two drugs, with the exception of hydrochlorothiazide, to achieve control
A history of drug or alcohol abuse within the past 5 years
Subjects who are currently abusing alcohol, illicit drugs, benzodiazepines, or narcotics
Inability to cooperate, comply with study procedures or communicate with the investigator to successfully complete the study
A history of benign prostate hypertrophy necessitating treatment
A history of psychiatric problems which, in the opinion of the investigators, would impair participation in the study
Subjects with a planned hospitalization during the study
An infirmity, disability, or geographical location which seems likely to prevent regular attendance for subject visits
Subjects with obstructive sleep apnea syndrome requiring CPAP therapy
Subjects diagnosed with central sleep apnea (> 5 central events per hour) or moderate to severe OSA (AHI > 15) and SpO2 <88 for > 5 min during sleep identified during screening
Use of the following medications within the time period specified below prior to Day -7 (Table 2)
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