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Completed

NCT Number: NCT05040828

Early Intervention in Allergic Patients

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.

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Key information

Conditions

Allergic Rhinitis Due to Weed Pollen Montelukast

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

No oral drug therapy throughout the pollen period

Drug

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

Primary outcomes

  1. The change of subjective AR symptoms

    Time frame: 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 outcomes

  1. The change of objective examination: nasal function

    Time frame: 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).

  2. The change of cytokine expression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

Early Intervention With Leukotriene Receptor Antagonists in Patients With Grass Pollinosis: Effects on Clinical Symptoms and Allergic Inflammation

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2021
Registry last updated
Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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