Early Intervention in Allergic Patients

Capital Medical University

Status and phase: Completed; Phase 4

Conditions: Montelukast; Allergic Rhinitis Due to Weed Pollen

Treatments: Drug: No oral drug therapy throughout the pollen period; Behavioral: Start taking Montelukast Sodium Tablets 10mg quaque die orally two weeks before peak pollen count.; Behavioral: Montelukast Sodium Tablets 10mg quaque die orally was administered after peak pollen count.

Study type: Interventional

Funder types: Other

Identifiers

NCT05040828

TR-Early intervention

Details and patient eligibility

About

As many as 250 million people suffer from allergic rhinitis in China, which has a large population, early use of drugs may help better control the symptoms.This study aimed to investigate the effects of early interventional treatment with the leukotriene receptor antagonist (LTRA) montelukast on seasonal allergic rhinitis.

Enrollment: 59 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients showed distinct nasal symptoms (rhinorrhea, congestion, itching, and sneezing), and demonstrated sensitization to one of the grass pollen allergens (Artemisia, Chenopodium, and Humulus scandens) with an immunoglobulin (Ig) E ≥ 0.7 IU/mL, measured using the Pharmacia UniCAP system (Thermo Fisher Scientific China Co., Ltd., Shanghai, China).
• had not received any therapies for AR or antibiotics for at least 4 weeks before their outpatient clinic visit prior to the study
• all of the subjects in the study reside in Beijing.

Exclusion criteria

• Patients diagnosed with bronchial asthma, suffering from rhinitis outside the pollen season, chronic sinusitis, deviated nasal septum, using specific immunotherapy, or participating in another drug efficacy trial during the 4-week period preceding the study.
• pregnant women and minors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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59 participants in 3 patient groups

Early interventional treatment group

Experimental group

Description:

The patients in this group:oral drug therapy from onset of the low pollen stage (August 1st, 2020) to the end of the pollen stage (September 30, 2020). Intranasal corticosteroids (mometasone furoate) from the high pollen stage (August 14, 2020) to the end of the pollen stage (September 30, 2020).

Treatment:

Behavioral: Start taking Montelukast Sodium Tablets 10mg quaque die orally two weeks before peak pollen count.

Post-onset treatment group

Active Comparator group

Description:

The patients in this group: oral drug therapy after the high pollen stage (August 14, 2020) to the end of the pollen stage (September 30, 2020.). Intranasal corticosteroids (mometasone furoate) from the high pollen stage (August 14, 2020) to the end of the pollen stage (September 30, 2020).

Treatment:

Behavioral: Montelukast Sodium Tablets 10mg quaque die orally was administered after peak pollen count.

Control group

Active Comparator group

Description:

The patients in this group:Intranasal corticosteroids (mometasone furoate) from the high pollen stage (August 14, 2020) to the end of the pollen stage (September 30, 2020).

Treatment:

Drug: No oral drug therapy throughout the pollen period