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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo/Fluticasone Propionate | Placebo Comparator | Placebo Spray 2 Sprays QHS Fluticasone Propionate 1 spray BID |
|
| Oxymetazoline Hydrochloride /Fluticasone Propionate | Active Comparator | Oxymetazoline Hydrochloride 2 Sprays QHS Fluticasone Propionate 1 spray BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxymetazoline Hydrochloride | Drug | Proportion of the subjects with 50% reduction in AHI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with a decrease in the severity of daily nasal congestion as measured by the Nasal Congestion VAS. | 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. | 7 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine R Smith | Contact | 813-631-4024 | 207 | catherinesmith@health.usf.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Usf Asthma Allergy and Immunology Cru | Recruiting | Tampa | Florida | 33613 | United States |
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| Placebo | Drug | Proportion of the subjects with 50% reduction in AHI. |
|
|
| 2 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. |
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). |
| 6 weeks |
| The Congestion Quantifier 7 (CQ7) questionnaire will be used to assess for an improvement in nasal congestion based on symptoms. | 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. | 7 weeks |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010109 | Oxymetazoline |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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