Efficiency of azelastine hydrochloride and fluticasone propionate nasal spray to improve PAP adherence in patients with obstructive sleep apnea

Efficiency of azelastine hydrochloride and fluticasone propionate nasal spray to improve PAP adherence in patients with obstructive sleep apnea :A Double-blinded Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220308003

Enrollment

116

Registered

2022-03-08

Start date

2022-03-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PAP adherence in patients with obstructive sleep apnea Obstructive sleep apnea, PAP adherence, Intranasal corticosteroid, Continuous Positive Airway Pressure

Interventions

azelastine hydrochloride and fluticasone propionate nasal spray, One actuation (0.14 g) delivers azelastine hydrochloride137 micrograms and fluticasone propionate 50 micrograms twice daily,the placebo

intervention group,Placebo group

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. First time diagnosis of Obstrutive sleep apnea in Thammasat university hospital 2. Age beween 18 to 75 year 3. Willingness to volunteer to participate in the trial and sign yhe informed consent form

Exclusion criteria

Exclusion criteria: 1. use of any intranasal corticosteroids during the last 3 months 2. any serious impair cognitive function or dementia or psychological disorder likely to preclude completion of the trial 3. any disease that have indication to use Intranasal corticosteroid 4. any other sleep disorder eg. Narcolepsy, Insomnia, Parasomnia, Central sleep apnea

Design outcomes

Primary

Measure	Time frame
PAP adherence at 1 month after end of the intervention the percentage of days the CPAP device was used for more than or equal to 4 hours per day on CPAP device's data	—

Secondary

Measure	Time frame
Nasal symptom at 1 month after end of the intervention Total nasal symptom score,Sleepiness at 1 month after end of the intervention Epworth Sleepiness Scale ,Quality of Life at 1 month after end of the intervention Rhinoconjunctivitis Quality of Life Questionnaire ,Nasal symptom at 1 month after end of the intervention Visual analog scale ,the number of hours per day the device was used (average hour/day used) at 1 month after end of the intervention CPAP device data,leakage value (95th percentile leakage) at 1 month after end of the intervention CPAP device data,the percentage number of days the CPAP device was used at 1 month after end of the intervention CPAP device data,AHI value after treatment at 1 month after end of the intervention CPAP device data,pressure below 15 cm H2O at 1 month after end of the intervention the percentage of days the CPAP device was used for more than or equal to 4 hours per day on CPAP device's data	—

Measure

Time frame

Nasal symptom at 1 month after end of the intervention Total nasal symptom score,Sleepiness at 1 month after end of the intervention Epworth Sleepiness Scale ,Quality of Life at 1 month after end of the intervention Rhinoconjunctivitis Quality of Life Questionnaire ,Nasal symptom at 1 month after end of the intervention Visual analog scale ,the number of hours per day the device was used (average hour/day used) at 1 month after end of the intervention CPAP device data,leakage value (95th percentile leakage) at 1 month after end of the intervention CPAP device data,the percentage number of days the CPAP device was used at 1 month after end of the intervention CPAP device data,AHI value after treatment at 1 month after end of the intervention CPAP device data,pressure below 15 cm H2O at 1 month after end of the intervention the percentage of days the CPAP device was used for more than or equal to 4 hours per day on CPAP device's data

—

Countries

Thailand

Contacts

Public ContactRachata Wongchan

Thammasat University Hospital

tameddoc@gmail.com0619645425

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026