Short Treatment with Omalizumab for Severe Asthma

NCT04763447 | Recruiting Phase 4

• 3 other identifiers: APHP1806142024-513427-17-002020-000883-42
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

The optimal duration of the treatment by OMA remains unclear when asthma is well controlled. Data suggest that a large part of patients with well controlled asthma can discontinue OMA therapy without any asthma control deterioration or with an acceptable decrease in asthma control, therefore French experts propose that omalizumab can be given for "3 to 5 yrs if asthma remains well controlled". The costs related to OMA are high and frequent injections represent severe constraints for patients. For all these reasons, evaluating whether shortening duration of OMA therapy is feasible while maintaining acceptable asthma control is a critical point. Therefore, the aim of this study is to evaluate asthma control after OMA discontinuation after at least 33 months of treatment when asthma is well controlled.

Conditions

Asthma

Keywords

severe asthma; omalizumab; allergy; biologic

Outcome Measures

Primary Outcomes (1)

• Number of exacerbations

  Number of asthma exacerbations in the year following randomization. An exacerbation is defined as an oral or injectable steroid course for at least 2 days and/or a minimum doubling of the usual steroid dose for at least 2 days for steroid dependent patients. They will be assessed every 6 months from patients log book, written reports of ER visits or hospitalizations, and prescriptions

  12 months

Secondary Outcomes (37)

• Time to exacerbation

  12 months

• Asthma control (ACT)

  6 months

• Asthma control (ACT)

  12 months

• 5 points-decrease of asthma control (ACT)

  6 months

• 5 points-decrease of asthma control (ACT)

  12 months

Study Arms (2)

OMA withdrawal attempt

EXPERIMENTAL

Patients will be told to stop abruptly (no progressive decrease of the dose) their Omalizumab treatment and they will not be prescribed new OMA

Other: Attempt to withdrawal OMA treatment

OMA continuation

ACTIVE COMPARATOR

Patients will be prescribed the same dosage of Omalizumab than they received before randomization

Drug: Continuation of OMA treatment

Interventions

Attempt to withdrawal OMA treatment OTHER

Patients will be told to stop abruptly (no progressive decrease of the dose) their Omalizumab treatment and they will not be prescribed new OMA. In case of loss of control, pulmonologist can adapt asthma treatment, as in usual care. In that case, OMA can be prescribed for a second line

OMA withdrawal attempt

Continuation of OMA treatment DRUG

Patients will be prescribed the same dosage of Omalizumab than they received before randomization, according to their weight and total circulating IgE levels. In case of safety concerns or loss of control, pulmonologist can modify the patient treatment regimen of OMA or other co-medications, as in usual care.

OMA continuation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient \>18 years old
• Treated with OMA, prescribed by a pulmonologist , for at least 33 months for severe allergic asthma

You may not qualify if:

• Patient refusing to stop OMA treatment, whatever the reason
• Patient with other reason other than good asthma control to stop OMA, such as a side effect, planned or ongoing pregnancy, or planned switch to another step 5 asthma treatment (mepolizumab, benralizumab, dupilumab, reslizumab, daily oral steroids, bronchial thermoplasty, …)
• Patient not covered by Health Insurance
• Patient under curatorship, guardianship or safeguarding of justice
• Patient whose adherence to asthma treatments is considered poor or questionable by the investigator
• Patient participating in another intervention research
• Pregnant or lactating patient
• Patient refusing to sign consent

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat-Claude Bernard

Paris, Île-de-France Region, 75018, France

RECRUITING

MeSH Terms

Conditions

Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Camille TAILLE, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camille TAILLE, Professor

CONTACT

01 40 25 68 63; camille.taille@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: May 20, 2021
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): May 20, 2027
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

FR (1)