Steroid and/or Prednisone Dependent AsthmaPhase 2/3NCT02049294

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

A Phase 2/3 study testing Omalizumab (Xolair) in people with Steroid and/or Prednisone Dependent Asthma and Eosinophilic Bronchitis, run by McMaster University at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Steroid and/or Prednisone Dependent Asthma, Eosinophilic Bronchitis
What is being tested?: Omalizumab (Xolair)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 5 sitesCanada
Study dates: Mar 2014to Sep 2017
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Confirmed asthma within the past 2 years (12% bronchodilator reversibility or PC20 methacholine less than 8 mg/ml)
ACQ ≥1.5 and sputum eos ≥3% at the time of randomization
On ICS (≥ 1500 mcg fluticasone propionate or equivalent) with or without additional prednisone
Total serum IgE ≥30 IU/L and positive allergy skin prick test
Age between 18 and 75 years
Ability to provide informed consent

Who cannot join

Current smoker or ex-smokers with greater than 20 pack years
Co-morbid diseases which in the investigator's opinion would make the patient unsuitable to participate in the study
Currently on Omalizumab or has previously been treated with Omalizumab
Currently on other biologic therapies (eg. Prolia)
Pregnancy or lactation
Post bronchodilator FEV1 less than 50% predicted

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Canada5 sites

Richard Leigh
Calgary, Alberta
McMaster University
Hamilton, Ontario
University of Laval
Laval, Quebec
University of Montreal
Montreal, Quebec
University of British Columbia
Vancouver, British Columbia

Other trials in Canada

About this study

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

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.

Conditions: Steroid and/or Prednisone Dependent Asthma, Eosinophilic Bronchitis
Being tested: Omalizumab (Xolair), Placebo
Keywords: Prednisone, Eosinophils, Immunoglobin E (IgE), Asthma, Bronchitis, Inflammation, Allergy
Medical subject headings: Asthma, Bronchitis, Inflammation, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omalizumab (Xolair)Biological
Also called Anti IgE
PlaceboDrug
Also called 0.9% normal saline

Study groups in NCT02049294
Study group	Role	What they receive
Omalizumab (Xolair)	Active comparator	Dosage/frequency is dependent on body weight (kg) and baseline blood IgE level. Receives: Drug: Placebo
Placebo (Normal Saline)	Placebo comparator	0.9% normal saline equivalent to the dosage/frequency/duration of Omalizumab Receives: Biological: Omalizumab (Xolair)

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of patients with change in absolute % count of sputum eosinophil week 0 to week 12, and week 12 to week 32
Measured: From Week 0 to Week 12 and Week 12 to week 32
Magnitude of the reduction in the dose of corticosteroid from week 12 to week 32.
Measured: From Week 12 to Week 32

Secondary outcomes (7)

change in % sputum eosinophil
Measured: From Week 0 to Week 32
Blood eosinophils
Measured: From Week 0 to week 32
Forced Expired Volume in 1 second (FEV1)
Measured: From Week 0 to Week 32
Ratio of Forced Expired Volume in 1 second to Forced Vital Capacity (FEV1/VC)
Measured: From Week 0 to Week 32
Provocative concentration causing a 20% drop in FEV1 (PC20)
Measured: From Week 0 to Week 32
Asthma Control Questionnaire
Measured: From Week 0 to Week 32
Fraction of exhaled nitric oxide (FeNO)
Measured: From Week 0 to Week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Sep 2017

First posted30 Jan 2014 (estimated)
Study startMar 2014
Primary completionSep 2017
Study completionSep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Steroid and/or Prednisone Dependent AsthmaStudies of the same condition, open and under way.
More trials run by McMaster UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02049294
Sponsor's protocol ID: RP 14-008
Status last verified: Jan 2018
First submitted: 28 Jan 2014
Last updated: 4 Apr 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Mukherjee M, Kjarsgaard M, Radford K, Huang C, Leigh R, Dorscheid DR, Lemiere C, Boulet LP, Waserman S, Martin J, Nair P. Omalizumab in patients with severe asthma and persistent sputum eosinophilia. Allergy Asthma Clin Immunol. 2019 Apr 3;15:21. doi: 10.1186/s13223-019-0337-2. eCollection 2019.
PubMed 30988677

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Double Blind Placebo Controlled Trial of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis
ClinicalTrials.gov ID: NCT02049294
Acronym / sponsor ID: RP 14-008
Conditions: Steroid and/or Prednisone Dependent Asthma, Eosinophilic Bronchitis
Keywords: Prednisone, Eosinophils, Immunoglobin E (IgE), Asthma, Bronchitis, Inflammation, Allergy
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: McMaster UniversityUniversity, hospital or other
Collaborators: Novartis
Study start: Mar 2014
Primary completion: Sep 2017 (actual)
Study completion: Sep 2017 (actual)
First posted: 30 Jan 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Omalizumab (Xolair)	Active comparator	Drug: PlaceboDosage/frequency is dependent on body weight (kg) and baseline blood IgE level.
Placebo (Normal Saline)	Placebo comparator	Biological: Omalizumab (Xolair)0.9% normal saline equivalent to the dosage/frequency/duration of Omalizumab

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Confirmed asthma within the past 2 years (12% bronchodilator reversibility or PC20 methacholine less than 8 mg/ml)
ACQ ≥1.5 and sputum eos ≥3% at the time of randomization
On ICS (≥ 1500 mcg fluticasone propionate or equivalent) with or without additional prednisone
Total serum IgE ≥30 IU/L and positive allergy skin prick test
Age between 18 and 75 years

Key exclusion criteria (6 listed)

Current smoker or ex-smokers with greater than 20 pack years
Co-morbid diseases which in the investigator's opinion would make the patient unsuitable to participate in the study
Currently on Omalizumab or has previously been treated with Omalizumab
Currently on other biologic therapies (eg. Prolia)
Pregnancy or lactation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omalizumab (Xolair)Also: Anti IgE	Biological	Placebo (Normal Saline)
PlaceboAlso: 0.9% normal saline	Drug	Omalizumab (Xolair)

Primary outcome

Proportion of patients with change in absolute % count of sputum eosinophil week 0 to week 12, and week 12 to week 32
Time frame: From Week 0 to Week 12 and Week 12 to week 32
Magnitude of the reduction in the dose of corticosteroid from week 12 to week 32.
Time frame: From Week 12 to Week 32

7 secondary outcomes

change in % sputum eosinophil
Time frame: From Week 0 to Week 32
Blood eosinophils
Time frame: From Week 0 to week 32
Forced Expired Volume in 1 second (FEV1)
Time frame: From Week 0 to Week 32
Ratio of Forced Expired Volume in 1 second to Forced Vital Capacity (FEV1/VC)
Time frame: From Week 0 to Week 32
Provocative concentration causing a 20% drop in FEV1 (PC20)
Time frame: From Week 0 to Week 32
Asthma Control Questionnaire
Time frame: From Week 0 to Week 32
Fraction of exhaled nitric oxide (FeNO)
Time frame: From Week 0 to Week 32

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
Derived from this study: PubMed 30988677Mukherjee M, Kjarsgaard M, Radford K, Huang C, Leigh R, Dorscheid DR, Lemiere C, Boulet LP, Waserman S, Martin J, Nair P. Omalizumab in patients with severe asthma and persistent sputum eosinophilia. Allergy Asthma Clin Immunol. 2019 Apr 3;15:21. doi: 10.1186/s13223-019-0337-2. eCollection 2019.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Parameswaran Nair, MD, PhD principal investigator

McMaster University

Louis-Philippe Boulet, MD principal investigator

University of Laval

Catherine Lemiere, MD principal investigator

Université de Montréal

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Omalizumab (Xolair) in people with Steroid and/or Prednisone Dependent Asthma and Eosinophilic Bronchitis, run by McMaster University at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with change in absolute % count of sputum eosinophil week 0 to week 12, and week 12 to week 32 (time frame: From Week 0 to Week 12 and Week 12 to week 32). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02049294, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.