Sleep ApneaPhase 4NCT02630121
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 testing Oxymetazoline Hydrochloride in people with Sleep Apnea and Chronic Nasal Congestion, run by University of South Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Apnea, Chronic Nasal Congestion
- What is being tested?
- Oxymetazoline Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to Apr 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Usf Asthma Allergy and Immunology Cru
Tampa, Florida, 33613
Catherine Smith, 813-631-4024 ext. 207, catherinesmith@health.usf.edu
RICHARD F LOCKEY, MD
About this study
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.
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.
Read the 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.
- 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.
- The Congestion Quantifier 7 (CQ7) questionnaire will be used to assess for an improvement in nasal congestion based on symptoms from the prior week.
- 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.
- 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.
- Conditions
- Sleep Apnea, Chronic Nasal Congestion
- Being tested
- Oxymetazoline Hydrochloride, Placebo
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymetazoline HydrochlorideDrug
Also called Afrin
Proportion of the subjects with 50% reduction in AHI.
PlaceboDrug
Also called Nasal saline
Proportion of the subjects with 50% reduction in AHI.
| Study group | Role | What they receive |
|---|---|---|
| Placebo/Fluticasone Propionate | Placebo comparator | Placebo Spray 2 Sprays QHS Fluticasone Propionate 1 spray BID Receives: Drug: Placebo |
| Oxymetazoline Hydrochloride /Fluticasone Propionate | Active comparator | Oxymetazoline Hydrochloride 2 Sprays QHS Fluticasone Propionate 1 spray BID Receives: Drug: Oxymetazoline Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
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).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study start1 Apr 2023
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630121
- Sponsor's protocol ID
- PRO00001844
- Status last verified
- Jan 2025
- First submitted
- 22 Jul 2015
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02630121
- Acronym / sponsor ID
- PRO00001844
- Conditions
- Sleep Apnea, Chronic Nasal Congestion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
- The Congestion Quantifier 7 (CQ7) questionnaire will be used to assess for an improvement in nasal congestion based on symptoms from the prior week.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo/Fluticasone Propionate | Placebo comparator | Drug: PlaceboPlacebo Spray 2 Sprays QHS Fluticasone Propionate 1 spray BID |
| Oxymetazoline Hydrochloride /Fluticasone Propionate | Active comparator | Drug: Oxymetazoline HydrochlorideOxymetazoline Hydrochloride 2 Sprays QHS Fluticasone Propionate 1 spray BID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxymetazoline HydrochlorideAlso: AfrinProportion of the subjects with 50% reduction in AHI. | Drug | Oxymetazoline Hydrochloride /Fluticasone Propionate |
| PlaceboAlso: Nasal salineProportion of the subjects with 50% reduction in AHI. | Drug | Placebo/Fluticasone Propionate |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxymetazoline Hydrochloride in people with Sleep Apnea and Chronic Nasal Congestion, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine R Smith (813-631-4024 ext. 207, catherinesmith@health.usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.