Early Intervention in Allergic Patients

NCT05040828 | Completed Phase 4 FDA Drug

• 1 other identifier: TR-Early intervention
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis Due to Weed Pollen; Montelukast

Outcome Measures

Primary Outcomes (1)

• The change of subjective AR symptoms

  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.

  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.

Secondary Outcomes (2)

• 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.

• 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.

Study Arms (3)

Early interventional treatment group

EXPERIMENTAL

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).

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

Post-onset treatment group

ACTIVE COMPARATOR

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).

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

Control group

ACTIVE COMPARATOR

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).

Drug: No oral drug therapy throughout the pollen period

Interventions

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

Start taking Montelukast Sodium Tablets 10mg quaque die orally two weeks before peak pollen count.Intranasal corticosteroids (mometasone furoate) 100μg was used in the group after peak pollen count.

Early interventional treatment group

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

10mg quaque die orally was administered after peak pollen count.Intranasal corticosteroids (mometasone furoate) 100μg was used in the group after peak pollen count.

Post-onset treatment group

No oral drug therapy throughout the pollen period DRUG

Intranasal corticosteroids (mometasone furoate) 100μg was used in the group after peak pollen count.

Control group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Interventions

montelukast

Study Officials

• Zhang Luo

  Beijing Institute of Otolaryngology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 10, 2021
• Study Start: July 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: November 10, 2020
• Last Updated: September 10, 2021

Record last verified: 2021-08

Locations

CN (1)