Early Intervention in Allergic Patients

Phase 4

Completed

• Conditions: Allergic Rhinitis Due to Weed Pollen; Montelukast
• Interventions: 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.; Drug: No oral drug therapy throughout the pollen period

• Registration Number: NCT05040828
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2020-09-30
• Study Completion: 2020-11-10
• Status Verified: 2021-08
• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-09-01
• Last Update Submitted: 2021-09-01
• Study First Posted: 2021-09-10
• Last Update Posted: 2021-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early interventional treatment group	Start taking Montelukast Sodium Tablets 10mg quaque die orally two weeks before peak pollen count.	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).
Post-onset treatment group	Montelukast Sodium Tablets 10mg quaque die orally was administered after peak pollen count.	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).
Control group	No oral drug therapy throughout the pollen period	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).

Primary Outcome Measures

Name	Time	Method
The change of subjective AR symptoms	baseline, visit 1: 2 weeks prior to the high weed pollen stage, visit 2: high weed pollen stage, visit 3: 2 weeks after the high weed pollen stage.	Symptom change before and after treatment was estimated by Visual analogue scale(VAS) symptom score. The VAS symptom scores ranged from 0 (asymptomatic) to 10 (very severe). The questionnaire included nasal symptoms: nasal congestion, nasal discharge, sneezing, and rhinocnesmus; eye symptoms: lacrimation, eye itching, eye redness, swelling, and ophthalmodynia; airway symptoms: wheezing, chest constriction, cough, labored breathing.

Secondary Outcome Measures

Name	Time	Method
The change of objective examination: nasal function	baseline, visit 1: 2 weeks prior to the high weed pollen stage, visit 2: high weed pollen stage, visit 3: 2 weeks after the high weed pollen stage.	Eccovision acoustic rhinometry was used to measure the nasal cavity volume (NCV) according to standardized recommendations. Measurements of nasal volume were made from the first 2 cm (V2), the first 4 cm (V4), from the first 6 cm (V6), from the segment between 0 and 5 cm (V0-5), and the segment between 0 and 7 cm (V0-7) of the nose. All measurements were performed three times by the same operator, and nasal volumes were calculated as the sum of both nostrils24. In the current study, the change in the nasal cavity volume was measured at 2-5 cm, as this seems to be an important variable for mucosal changes.24 Nasal airway resistance (NAR) was measured by anterior active rhinomanometry in a quiet room at temperature of 25°C and humidity of 70%. NAR was measured at 75 Pa point (R75T).
The change of cytokine expression	baseline, visit 1: 2 weeks prior to the high weed pollen stage, visit 2: high weed pollen stage, visit 3: 2 weeks after the high weed pollen stage.	Quantitative real-time reverse transcription PCR (qRT-PCR) was used to analyze the mRNA expression levels of the cytokines interleukin-4, interleukin-5, interleukin-13, leukotriene C4, RANTES, tumor necrosis factor-α, thymic stromal lymphopoietin, and EOTAXIN in the nasal mucosa before and after treatment. The qRT-PCR data were processed using the 2-△△CT method.

Trial Locations

Locations (1)

Beijing Tongren Hospital; 🇨🇳 Beijing, Beijing, China