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Completed

NCT Number: NCT04489121

The Efficacy of Preseasonal Omalizumab Treatment

Allergic rhinitis (AR) is induced by an immunoglobulin E (IgE)-mediated reaction in the allergen-sensitized subjects, affecting 10% to 40% of the world population. AR could be divided into two kinds, perennial AR and seasonal AR (SAR).

In recent years, biologics have become promising drugs for allergic diseases. The efficacy and safety of Omalizumab in treating SAR have been well proven by previous studies. However, the efficacy in preseasonal treatment for SAR has not yet been studied before.

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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

  • Male or female outpatients aged 18 to 60 years (inclusive).
  • With history of SAR for at least two years, with/without conjunctivitis and without asthma
  • Two or more nasal symptoms scores were ≥ 2 points during July - October in the last year.
  • Sensitised to common autumn pollens including sagewort and ragweed (a specific IgE level ≥ 3.5 kU/L).
  • Patients who have been informed of the nature and aims of the study and have given their written consent, willing to comply with the protocol.
  • Patients who are able to understand the information given and the consent and complete the daily record card.

Exclusion criteria

  • Patients with oral diseases/ allergies within the run-in period.
  • Patients accepted any kind of operations within 4 weeks of the run-in period.
  • Patients applied for systemic glucocorticoids within 4 weeks in the run-in period.
  • Patients with PAR.
  • Patients with any nasal condition that could confound the results of the study (chronic rhinitis, chronic rhinosinusitis with/without polyps).
  • Whatever the co-sensitization leading to clinically relevant AR, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study.
  • patients with comorbidity of severe asthma.
  • Patients applying beta-antagonist (local or systemic appliance).
  • Pregnant, breast-feeding / sexually active women of childbearing potential.
  • Patients treated with AIT for pollens within 3 years.
  • Participation in any clinical study within the 3 months of the run-in period.
  • Patients at risk of non-compliance..
  • Patients with immunologic suppression, diabetes mellitus, autonomic neuropathy, coronary heart disease or hypertension.

Treatment and study plan

Omalizumab

Drug

For patients in the Omalizumab group, subcutaneous injections of Omalizumab based on the specific participant's weight and serum total IgE was performed 2 weeks prior the anticipated pollen season.

Primary outcomes

  1. the change of total nasal symptoms scores

    Time frame: at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).

  2. Rescue medication score

    Time frame: at week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).

    when the symptoms were very severe and could not tolerated, the patients could use loratadine as rescue medication.

    The need for rescue medication was assessed as rescue medication score (RMS), analyzed as the weekly sum of daily use of Loratadine (10mg/d, equivalent to 1 point) or nasal corticosteroid spray (2 points)

Secondary outcomes

  1. the change of quality of life

    Time frame: at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).

    mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ)

  2. adverse events

    Time frame: one hour after injection in the Omalizumab group

    Any adverse event following injection was assessed by physicians and patients. Patients in the Omalizumab group are instructed to record any unexpected signs, symptoms, and feelings during the subcutaneous injection of Omalizumab.

  3. eosinophilic indicators in nasal secretions

    Time frame: at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).

    The level of eosinophilic indicators; Charcot-Leyden crystal (CLC) , Cystatin SN

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

The Efficacy of Preseasonal Omalizumab Treatment in Seasonal Allergic Rhinitis Patients

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 28, 2020
Registry last updated
Jan 28, 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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