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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

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ClinicalTrials.gov Identifier: NCT02630121
Recruitment Status : Recruiting
First Posted : December 15, 2015
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of South Florida

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Chronic Nasal Congestion Drug: Oxymetazoline Hydrochloride Drug: Placebo Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Double Blinded Placebo Controlled, Crossover Prospective Trial.
Estimated Study Start Date : June 3, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
Placebo Comparator: Placebo/Fluticasone Propionate
Placebo Spray 2 Sprays QHS Fluticasone Propionate 1 spray BID
Drug: Placebo
Proportion of the subjects with 50% reduction in AHI.
Other Name: Nasal saline

Active Comparator: Oxymetazoline Hydrochloride /Fluticasone Propionate
Oxymetazoline Hydrochloride 2 Sprays QHS Fluticasone Propionate 1 spray BID
Drug: Oxymetazoline Hydrochloride
Proportion of the subjects with 50% reduction in AHI.
Other Name: Afrin




Primary Outcome Measures :
  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. [ Time Frame: 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.


Secondary Outcome Measures :
  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. [ Time Frame: 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), upper airway flow limitation will be measured by a change in the flattening index from a value of ≥ 0.01 to 0.14 (moderate to severe airflow limitation) to a value of 0.15 - 0.3+ (mild airflow limitation to completely open upper airway).


Other Outcome Measures:
  1. The proportion of subjects with a decrease in the severity of daily nasal congestion as measured by the Nasal Congestion VAS. [ Time Frame: 7 weeks ]
    The proportion of subjects with a decrease in the severity of daily nasal congestion as measured by the Nasal Congestion VAS. Subjects will complete the Nasal Congestion VAS daily.

  2. 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. [ Time Frame: 6 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. Subjects will complete the questionnaire at visits 2, 3, 4, and 5 (total of 6 weeks).

  3. The Congestion Quantifier 7 (CQ7) questionnaire will be used to assess for an improvement in nasal congestion based on symptoms. [ Time Frame: 7 weeks ]
    The Congestion Quantifier 7 (CQ7) questionnaire will be used to assess for an improvement in nasal congestion based on symptoms from the prior week. Subjects will complete the questionnaire weekly for a total of 7 weeks.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Presence of hypersensitivity to oxymetazoline or fluticasone propionate.
  2. Subjects receiving allergen immunotherapy but not on a stable maintenance regimen for at least 30 days before the first study visit.
  3. 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.
  4. Women who are pregnant or lactating.
  5. Other known nasal diseases likely to affect deposition of oxymetazoline such as sinusitis, nasal polyps, or major nasal structural malformations.
  6. Respiratory tract infections in the last 14 days.
  7. Infections requiring antibiotics in the last 14 days.
  8. Asthma or chronic obstructive pulmonary disease (COPD) requiring roflumilast or more than the recommended doses of inhaled corticosteroids, beta agonists, or antimuscarinic agents.
  9. No systemic glucocorticosteroids for one month prior or during the study.
  10. Cardiovascular disease with uncontrolled hypertension (BP160/80), arrhythmias and/or congestive heart failure.
  11. Insulin-dependent diabetes mellitus and/or diabetic retinopathy.
  12. Subjects with mild OSA (AHI 5-14) and SpO2 <88 for > 5 min during sleep that is identified during the screening portable sleep study.
  13. Hypertension requiring more than two drugs, with the exception of hydrochlorothiazide, to achieve control.
  14. A history of drug or alcohol abuse within the past 5 years.
  15. Subjects who are currently abusing alcohol, illicit drugs, benzodiazepines, or narcotics.
  16. Inability to cooperate, comply with study procedures or communicate with the investigator to successfully complete the study.
  17. A history of benign prostate hypertrophy necessitating treatment.
  18. A history of psychiatric problems which, in the opinion of the investigators, would impair participation in the study.
  19. Subjects with a planned hospitalization during the study.
  20. An infirmity, disability, or geographical location which seems likely to prevent regular attendance for subject visits.
  21. Subjects with obstructive sleep apnea syndrome requiring CPAP therapy.
  22. 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.
  23. Use of the following medications within the time period specified below prior to Day -7 (Table 2).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630121


Contacts
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Contact: Catherine R Smith 813-631-4024 ext 207 catherinesmith@health.usf.edu

Locations
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United States, Florida
Usf Asthma Allergy and Immunology Cru Recruiting
Tampa, Florida, United States, 33613
Contact: Catherine Smith    813-631-4024 ext 207    catherinesmith@health.usf.edu   
Principal Investigator: RICHARD F LOCKEY, MD         
Sub-Investigator: DENNIS K LEDFORD, MD         
Sub-Investigator: ROGER W FOX, MD         
Sub-Investigator: MARK C GLAUM, MD         
Sponsors and Collaborators
University of South Florida

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02630121     History of Changes
Other Study ID Numbers: PRO00001844
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Fluticasone
Phenylephrine
Oxymetazoline
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Nasal Decongestants