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

NCT02630121 | Recruiting Phase 4 FDA Drug

• 1 other identifier: PRO00001844
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Apnea; Chronic Nasal Congestion

Outcome Measures

Primary Outcomes (1)

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

  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.

  2 weeks

Secondary Outcomes (1)

• The proportion of subjects demonstrating an improvement in moderate to severe upper airway flow limitation as measured by a change in the flattening index after treatment with oxymetazoline hydrochloride and fluticasone propionate for 2 weeks.

  2 weeks

Other Outcomes (3)

• The proportion of subjects with a decrease in the severity of daily nasal congestion as measured by the Nasal Congestion VAS.

  7 weeks

• 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.

  6 weeks

• The Congestion Quantifier 7 (CQ7) questionnaire will be used to assess for an improvement in nasal congestion based on symptoms.

  7 weeks

Study Arms (2)

Placebo/Fluticasone Propionate

PLACEBO COMPARATOR

Placebo Spray 2 Sprays QHS Fluticasone Propionate 1 spray BID

Drug: Placebo

Oxymetazoline Hydrochloride /Fluticasone Propionate

ACTIVE COMPARATOR

Oxymetazoline Hydrochloride 2 Sprays QHS Fluticasone Propionate 1 spray BID

Drug: Oxymetazoline Hydrochloride

Interventions

Oxymetazoline Hydrochloride DRUG

Proportion of the subjects with 50% reduction in AHI.

Also known as: Afrin

Oxymetazoline Hydrochloride /Fluticasone Propionate

Placebo DRUG

Proportion of the subjects with 50% reduction in AHI.

Also known as: Nasal saline

Placebo/Fluticasone Propionate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Usf Asthma Allergy and Immunology Cru

Tampa, Florida, 33613, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Oxymetazoline; Sodium Chloride

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Catherine R Smith

CONTACT

813-631-4024; catherinesmith@health.usf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: December 15, 2015
• Study Start: April 1, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

US (1)