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A randomized, placebo controlled trial on the effect of intranasal corticosteroid as a treatment for moderate to severe obstructive sleep apnea with coexisting chronic rhinitis

A randomized, placebo controlled trial on the effect of intranasal corticosteroid as a treatment for moderate to severe obstructive sleep apnea with coexisting chronic rhinitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180614004
Enrollment
Unknown
Registered
2018-06-14
Start date
2018-05-30
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Moderate to severe obstructive sleep apnea with chronic rhinitis Moderate to severe obstructive sleep apnea chronic rhinitis apnea hypopnea index intranasal steroid

Interventions

Fluticasone furoate&#44
Nasal spray 27.5 mcg/1dose&#44
120 doses/bottle&#44
1C 13/51 (N) [drug&#39
s ID],Placebo nasal spray&#44
contains glucose anhydrous&#44
polysorbate 80&#44
benzalkonium chloride&#44
disodium edetate&#44
Placebo Comparator Drug,Placebo Comparator Drug
intranasal steriod,placebo

Sponsors

NONE
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. 20-65 year old volunteers 2. Polysomnography test with apnea-hypopnea index at least 15 events per hour 3. Total nasal symptom score questionnaire required more than 6 4. Skin test required 5. Modified Mallampati grade 1-2

Exclusion criteria

Exclusion criteria: 1. Without serious co-morbidity disease; resistant hypertension, poor controlled cardiovascular disease, cerebrovascular disease 2. Morbid obesity; body mass index was more than 30 kg/m2 3. Oral appliance or continue positive airway pressure previous used 4. Bi-level positive airway pressure used 5. Previous intranasal steroid used within 3 months of research period 6. Could not attend 2 appointments and poor technique of drug used 7. Could not discontinue anti-allergy drug within 7 days of before enrollment

Design outcomes

Primary

MeasureTime frame
apnea hypopnea index 1 month polysomnography test

Secondary

MeasureTime frame
sleep quality 1 month questionnaire

Countries

thailand

Contacts

Public Contactvorakamol phoophiboon

faculty of medicine, Chulalongkorn university

rakamol@hotmail.com0819857600

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026