The Efficacy of Preseasonal Omalizumab Treatment

NCT04489121 | Completed

• 1 other identifier: Preseasonal-OMA-AR
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

• the change of total nasal symptoms scores

  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).

• 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)

  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 Outcomes (3)

• the change of quality of life

  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).

• adverse events

  one hour after injection in the Omalizumab group

• eosinophilic indicators in nasal secretions

  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).

Study Arms (2)

omalizumab preseasonal treatment

EXPERIMENTAL

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.

Drug: Omalizumab

control

NO INTERVENTION

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

Interventions

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.

omalizumab preseasonal treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Luo Zhang

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, Beijing TongRen Hospital

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 28, 2020
• Study Start: July 28, 2020
• Primary Completion: September 26, 2020
• Study Completion: October 1, 2020
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

CN (1)