Study of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis

Eosinophilic Bronchitis Clinical Trial

Official title:

Randomized Double Blind Placebo Controlled Trial of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02049294
• Other study ID #: RP 14-008
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 28, 2014
• Last updated: April 3, 2018
• Start date: March 2014
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether addition of Omalizumab enables a reduction in the dose of prednisone in patients with asthma and eosinophilic bronchitis.

This will be a double-blind placebo-controlled, 3-centre, randomized parallel group trial divided into two sequential study periods.

Period 1: After establishing the minimum dose of prednisone to maintain asthma control and maintain sputum eosinophils <3%, subjects will be randomized to either placebo or Omalizumab for 16 weeks (either once monthly for 4 months or every 2 weeks for 4 months).

Period 2: standardised prednisone reduction at intervals of 4-weeks until there is a clinical and eosinophilic exacerbation or bothersome steroid withdrawal effects. If patients have an exacerbation, they will be treated with prednisone. This patient will continue on Omalizumab or placebo during the entire duration of the study but not continue the phase of steroid reduction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria

1. Confirmed asthma within the past 2 years (12% bronchodilator reversibility or PC20 methacholine less than 8 mg/ml)

2. ACQ =1.5 and sputum eos =3% at the time of randomization

3. On ICS (= 1500 mcg fluticasone propionate or equivalent) with or without additional prednisone

4. Total serum IgE =30 IU/L and positive allergy skin prick test

5. Age between 18 and 75 years

6. Ability to provide informed consent

Exclusion criteria

1. Current smoker or ex-smokers with greater than 20 pack years

2. Co-morbid diseases which in the investigator's opinion would make the patient unsuitable to participate in the study

3. Currently on Omalizumab or has previously been treated with Omalizumab

4. Currently on other biologic therapies (eg. Prolia)

5. Pregnancy or lactation

6. Post bronchodilator FEV1 less than 50% predicted

Related Conditions & MeSH terms

• Acute Disease
• Bronchitis
• Eosinophilic Bronchitis
• Steroid and/or Prednisone Dependent Asthma

Intervention

Biological:
• Omalizumab (Xolair)

Drug:
• Placebo

Locations

Country	Name	City	State
Canada	Richard Leigh	Calgary	Alberta
Canada	McMaster University	Hamilton	Ontario
Canada	University of Laval	Laval	Quebec
Canada	University of Montreal	Montreal	Quebec
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Novartis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	• Sputum eosinophilopoietic cytokines, chemokines, immunoglobulin levels, expression variation of constitutive immunoglobulin receptors.		From Week 0 to Week 12 and Week 12 to week 32
Other	IgE antagonism and its effect on TSLP with respect to in situ eosinophilopoeisis and local eosinophil activity		From Week 0 to Week 12 and Week 12 to week 32
Primary	Proportion of patients with change in absolute % count of sputum eosinophil week 0 to week 12, and week 12 to week 32		From Week 0 to Week 12 and Week 12 to week 32
Primary	Magnitude of the reduction in the dose of corticosteroid from week 12 to week 32.		From Week 12 to Week 32
Secondary	change in % sputum eosinophil		From Week 0 to Week 32
Secondary	Blood eosinophils		From Week 0 to week 32
Secondary	Forced Expired Volume in 1 second (FEV1)		From Week 0 to Week 32
Secondary	Ratio of Forced Expired Volume in 1 second to Forced Vital Capacity (FEV1/VC)		From Week 0 to Week 32
Secondary	Provocative concentration causing a 20% drop in FEV1 (PC20)		From Week 0 to Week 32
Secondary	Asthma Control Questionnaire		From Week 0 to Week 32
Secondary	Fraction of exhaled nitric oxide (FeNO)		From Week 0 to Week 32