Early Intervention in Allergic Patients

NCT ID: NCT05040828

Last Updated: 2021-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-11-10

Brief Summary

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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

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Conditions

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Allergic Rhinitis Due to Weed Pollen Montelukast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Early interventional treatment group

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).

Group Type EXPERIMENTAL

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

Intervention Type 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.

Post-onset treatment group

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).

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Control group

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).

Group Type ACTIVE_COMPARATOR

No oral drug therapy throughout the pollen period

Intervention Type DRUG

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

Interventions

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

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.

Intervention Type BEHAVIORAL

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

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

Intervention Type BEHAVIORAL

No oral drug therapy throughout the pollen period

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhang Luo

Role: PRINCIPAL_INVESTIGATOR

Beijing Institute of Otolaryngology

Locations

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Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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TR-Early intervention

Identifier Type: -

Identifier Source: org_study_id

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