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OpenTrials
Completed

NCT Number: NCT04077892

Compare the Effect of INS Alone and Added LTRA in Treatment of SAR

It is not proven unequivocally whether a combination of an intranasal corticosteroids (INS) and a cysteinyl leukotriene receptor antagonist has greater efficacy than INS in the treatment of severe allergic rhinitis (AR) . We performed a randomized, open-label study in 46 seasonal AR subjects receiving budesonide (BD, 256ug) plus montelukast (MNT, 10 mg) or BD alone (256ug) for 2 weeks. Visual analog scale (VAS) scores, nasal cavity volume (NCV), nasal airway resistance (NAR) and fractional exhaled nitric oxide (FeNO) were assessed before and at end of treatments as the primary treatment outcomes. Similarly, histamine, eosinophil cationic protein (ECP) and cysteinyl-leukotrienes (Cyslts) in nasal secretion and Th1/Th2 cells in nasal mucosa were evaluated as the secondary treatment outcomes.

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Key information

Age range

18 year–47 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

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

  • moderate to severe seasonal allergic rhinitis
  • confirmed to had a diagnosis of SAR and also shown to be sensitized to mugwort allergen
  • had not received any therapies for AR or antibiotics for at least 7 days before their outpatient clinic visit prior to the study

Exclusion criteria

  • smokers
  • asthma (based on patient's history and pulmonary function tests)
  • had any other chronic disease
  • pregnant women

Treatment and study plan

Budesonide

Drug

SAR patients received treatment of a combination of budesonide and montelukast tablet or only intranasal budesonide randomly for 14 days

Other names: montelukast

Primary outcomes

  1. The change of subjective AR symptoms

    Time frame: at baseline, 14 days

    The participants were asked by one investigator to fill in a questioner detailing the presence of nasal and eye symptoms (including nasal congestion, rhinorrhea, nasal itching, sneezing and eye itching), and to score each symptom on a 0-10 cm scale; with 0 cm = no symptoms and 10 cm = most severe and bothersome symptom. The same investigator calculated both the individual symptom and the average of the sum of 5 AR symptoms scores, before and at the end of 14 days' treatment. Any subject with a mean score of < 4 cm at baseline was excluded from this study.

Secondary outcomes

  1. The change of objective examination: nasal patency

    Time frame: at baseline, 14 days

    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 Fractional Exhaled NO

    Time frame: at baseline, 14 days

    A nitric oxide analyser was used to measure exhaled nasal nitric oxide (nNO). Briefly, NO-free air was aspirated through the nasal cavity at a flow rate of 50 ml/s. The subject exhaled against the air-resistance, resulting in an intraoral pressure to close the velum and prevent mixture of oral and nasal gas. Nasal gas from this circuit was continuously routed in part directly into the analyser for determination of nNO, and the level of nNO(ppb) was calculated from a plateau lasting for at least 3s.

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

A Randomized Trial of Comparing a Combination of Montelukast and Budesonide With Budesonide in Allergic Rhinitis

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 4, 2019
Registry last updated
Sep 4, 2019

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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