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A multicenter, prospective, real-world study to evaluate the efficacy and safety of fluticasone propionate nasal spray prophylaxis compared with no prophylaxis in Chinese patients with seasonal allergic rhinitis (SAR)

A multicenter, prospective, real-world study to evaluate the efficacy and safety of fluticasone propionate nasal spray prophylaxis compared with no prophylaxis in Chinese patients with seasonal allergic rhinitis (SAR)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127876
Enrollment
Unknown
Registered
2026-07-09
Start date
2026-07-15
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Seasonal allergic rhinitis

Interventions

No prevention group:Treatment period (0d to 56d, including 28 days of preventive treatment medication and 28 days of symptomatic treatment medication)
The non-preventive group began to use fluticasone propionate nasal spray on the 28th day, twice per nostril once a day, until the 56th day. The total duration of use was 28 days respectively.
Short term prevention group:Treatment period (0d to 56d, including 28 days of preventive treatment medication and 28 days of symptomatic treatment medication)
The short-term prophylaxis group began using fluticasone propionate nasal spray on the 14th day, twice per nostril once a day, until the 56th day, with a total medication duration of 42 days.
Long term prevention team:Treatment period (0d to 56d, including 28 days of preventive treatment medication and 28 days of symptomatic treatment medication)
The long-term prevention group started using fluticasone propionate nasal spray on day 0, twice per nostril once a day, until day 56, with a total medication duration of 56 days.

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged 18 to 65 years; 2. There is a clear diagnosis of seasonal allergic rhinitis based on the medical history, with at least 2 consecutive pollen seasons; 3. Have a clear positive allergen test result (skin prick test or serum specific IgE test) within 12 months before screening or during the screening period; 4. The researcher determines that the patient has the ability to understand and be willing to comply with the requirements of the research protocol, and is able to complete electronic diary card recording; 5. Volunteer to participate in this study and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. People who are known to be allergic to fluticasone propionate or any excipients in the drug; 2. There are contraindications such as nasal septum perforation and active nasal infection (viral, fungal or bacterial); 3. There are abnormalities in the nasal anatomy that seriously affect nasal ventilation (such as severe nasal septum deviation, huge nasal polyps); 4. Use of nasal or systemic glucocorticoids within 4 weeks before the start of the study; 5. Use of any nasal or oral decongestants within 1 week before the start of the study; 6. Participated in any other interventional clinical trial within 3 months before the start of the study; 7. The researcher believes that the patient has any situation that may endanger his or her own safety or is unable to complete the study due to poor compliance and other reasons.

Design outcomes

Primary

MeasureTime frame
Total Nasal Symptom Score;

Secondary

MeasureTime frame
Treatment Satisfaction Questionnaire for Medication;The total dose of fluticasone propionate nasal spray during the main observation period (measured in number of sprays or micrograms);Proportion of symptom-free days during primary observation period;The incidence of adverse events (AE) during the main observation period;Rhinoconjunctivitis Quality of Life Questionnaire;The frequency and quantity of emergency drugs used during the main observation period;

Countries

China

Contacts

Public ContactGuan Kai

Peking Union Medical College Hospital

dr_guankai@126.com+86 10 69151601

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026