Status:
COMPLETED
The Efficacy of Preseasonal Omalizumab Treatment
Lead Sponsor:
Beijing Tongren Hospital
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Allergic rhinitis (AR) is induced by an immunoglobulin E (IgE)-mediated reaction in the allergen-sensitized subjects, affecting 10% to 40% of the world population. AR could be divided into two kinds, ...
Eligibility Criteria
Inclusion
- Male or female outpatients aged 18 to 60 years (inclusive).
- With history of SAR for at least two years, with/without conjunctivitis and without asthma
- Two or more nasal symptoms scores were ≥ 2 points during July - October in the last year.
- Sensitised to common autumn pollens including sagewort and ragweed (a specific IgE level ≥ 3.5 kU/L).
- Patients who have been informed of the nature and aims of the study and have given their written consent, willing to comply with the protocol.
- Patients who are able to understand the information given and the consent and complete the daily record card.
Exclusion
- Patients with oral diseases/ allergies within the run-in period.
- Patients accepted any kind of operations within 4 weeks of the run-in period.
- Patients applied for systemic glucocorticoids within 4 weeks in the run-in period.
- Patients with PAR.
- Patients with any nasal condition that could confound the results of the study (chronic rhinitis, chronic rhinosinusitis with/without polyps).
- Whatever the co-sensitization leading to clinically relevant AR, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study.
- patients with comorbidity of severe asthma.
- Patients applying beta-antagonist (local or systemic appliance).
- Pregnant, breast-feeding / sexually active women of childbearing potential.
- Patients treated with AIT for pollens within 3 years.
- Participation in any clinical study within the 3 months of the run-in period.
- Patients at risk of non-compliance..
- Patients with immunologic suppression, diabetes mellitus, autonomic neuropathy, coronary heart disease or hypertension.
Key Trial Info
Start Date :
July 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04489121
Start Date
July 28 2020
End Date
October 1 2020
Last Update
January 28 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Tongren Hospital
Beijing, Beijing Municipality, China, 100730