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The Efficacy of Preseasonal Omalizumab Treatment

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Omalizumab
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Tongren Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

omalizumab preseasonal treatment

control

Arm Description

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. Rescue medication could be used during pollen seasons.

No preseasonal treatment was performed. Rescue medication could be used during pollen seasons.

Outcomes

Primary Outcome Measures

the change of total nasal symptoms scores
Rescue medication score
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 Outcome Measures

the change of quality of life
mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ)
adverse events
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.
eosinophilic indicators in nasal secretions
The level of eosinophilic indicators; Charcot-Leyden crystal (CLC) , Cystatin SN

Full Information

First Posted
July 22, 2020
Last Updated
January 26, 2021
Sponsor
Beijing Tongren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04489121
Brief Title
The Efficacy of Preseasonal Omalizumab Treatment
Official Title
The Efficacy of Preseasonal Omalizumab Treatment in Seasonal Allergic Rhinitis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
September 26, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
omalizumab preseasonal treatment
Arm Type
Experimental
Arm Description
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. Rescue medication could be used during pollen seasons.
Arm Title
control
Arm Type
No Intervention
Arm Description
No preseasonal treatment was performed. Rescue medication could be used during pollen seasons.
Intervention Type
Drug
Intervention Name(s)
Omalizumab
Intervention Description
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 Outcome Measure Information:
Title
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).
Title
Rescue medication score
Description
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)
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).
Secondary Outcome Measure Information:
Title
the change of quality of life
Description
mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ)
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).
Title
adverse events
Description
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.
Time Frame
one hour after injection in the Omalizumab group
Title
eosinophilic indicators in nasal secretions
Description
The level of eosinophilic indicators; Charcot-Leyden crystal (CLC) , Cystatin SN
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luo Zhang
Organizational Affiliation
Beijing Tongren Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

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The Efficacy of Preseasonal Omalizumab Treatment

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