Severe AsthmaPhase 2NCT03074942
Reslizumab in Patients With Severe Asthma Who Failed to Respond to Omalizumab
A Phase 2 study testing Reslizumab in people with Severe Asthma, run by Sociedad Española de Neumología y Cirugía Torácica at 10 sites in Spain.
Trial summary
Approximately, 5% of the patients with asthma suffer a difficult-to-control severe variant of the disease. Despite being treated with inhaled corticosteroids (ICs), long-acting β2-agonists (LABA), oral corticosteroids or omalizumab, one or more components of the control concept (symptoms, exacerbations, bronchial… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Severe Asthma
- What is being tested?
- Reslizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 10 sitesSpain
- Study dates
- 20 Apr 2017to 30 Apr 2018
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 70 years of age,
- Patients diagnosed with severe uncontrolled asthma
- Patients who give informed consent.
- Previous treatment with omalizumab that was discontinued because lack of efficacy (symptoms -ACT <20, exacerbations) or adverse effects.
- Patients with a high blood eosinophil count (400 μl) at least once in the previous 3 years.
- Women should be surgically sterilized, at least 2 years have passed since menopause, or must have a negative pregnancy test within 7 days prior to initiation of treatment.
- Women of childbearing potential (not surgically sterilized or menopausal for less than 2 years) should use a medically accepted method of contraception and should agree to continue using this method during the study and at least 30 days after the end of the study.
- Patient should be willing and able to comply with the study restrictions and attend the visits indicated in the protocol to carry out the follow-up evaluations detailed in the protocol.
Who cannot join
- Diagnosis of asthma-COPD (Chronic Obstructive Pulmonary Disease) overlap syndrome.
- Active and former smokers of>10 packages / year.
- Exacerbations during the previous 4 weeks.
- Current treatment with omalizumab or last dose of omalizumab in the 5 months prior to inclusion of the patient in the study. 5- Exposure to another monoclonal antibody.
- Participation in another clinical trial.
- Uncontrolled clinically significant disease, which may interfere with study procedures, interpretation of efficacy results, or compromise patient safety.
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- Underlying lung disorder.
- Known hypereosinophilic syndrome.
- A pregnant or lactating woman, or who intends to become pregnant during the study.
- Participation in a clinical trial within 30 days prior to the start of treatment.
- Previous exposure to reslizumab or other anti-IL-5 monoclonal antibody.
- Immunodeficiency disorder, including HIV.
- Suspected drug or alcohol abuse.
- Active helminth parasite infection or for which treatment was received in the 6 months prior to the start of treatment.
- History of allergic reaction or hypersensitivity to any component of the study drug.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital Universitario de Cruces
Barakaldo, Bizkaia, 48903
Hospital Clínic i Provincial de Barcelona
Barcelona, 08036
Hospital Reina Sofía
Córdoba, 14004
Hospital Galdakao-Usansolo
Galdakao, Vizcaya, 48960
Hospital Universitario Lucus Augusti
Lugo, 27003
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitari Son Espases
Palma, Balearic Islands, 07120
Hospital de Sabadell
Sabadell, Barcelona, 08208
Hospital Virgen Del Rocío
Seville, 41013
Hospital Universitario Dr. Peset
Valencia, 46017
About this study
Official title: Reslizumab in Patients With Severe Asthma Who Failed to Respond to Omalizumab: a Pilot Study
Approximately, 5% of the patients with asthma suffer a difficult-to-control severe variant of the disease. Despite being treated with inhaled corticosteroids (ICs), long-acting β2-agonists (LABA), oral corticosteroids or omalizumab, one or more components of the control concept (symptoms, exacerbations, bronchial obstruction) remain to be resolved. Omalizumab has been proven to safely reduce asthma exacerbations and to decease symptoms and quality of life in severe allergic asthmatics. However, approximately 25% of the treated patients fail to respond to this monoclonal antibody. The rest of them show different degrees of response, although the rate of asthmatics who achieve control of the disease is unknown because clinical trials of omalizumab have been carried out to assess the impact of the drug on exacerbations, symptoms or even pulmonary function, but its effect on control was not evaluated. Therefore, there is a need to find new therapeutic options for those severe asthmatics who remain uncontrolled despite having received all the recommended therapies (including omalizumab). Reslizumab is a humanized anti-interleukin-5 (IL-5) monoclonal antibody (mAb) that has been recently found to reduce exacerbations and to improve pulmonary function and symptoms in patients with severe asthma and high peripheral eosinophil counts. It would be important to demonstrate that Reslizumab is able to improve the clinical condition of severe asthma patients with no therapeutic options.
- Conditions
- Severe Asthma
- Being tested
- Reslizumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReslizumabDrug
Reslizumab 3 mg/kg once / every 4 weeks during 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Reslizumab | Experimental | Reslizumab 3 mg/kg once / every 4 weeks during 24 weeks Receives: Drug: Reslizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Asthma Control Test score (ACT)
Change in Asthma Control Test score (ACT) between baseline and week 24.
Measured: Baseline and 24 weeks
Secondary outcomes (11)
Change from baseline in Asthma Control Test (ACT) score
Change in ACT between baseline and week 12
Measured: Baseline and 12 weeks
Change from baseline in the 7-item Asthma Control Questionnaire (ACQ).
Change in the 7-item ACQ between baseline and week 24.
Measured: Baseline and 24 weeks
Percentage of patients that achieve the minimally important difference in ACT
Percentage of patients that achieve the minimally important difference in ACT (increase of at least 3 ponints) at week 24
Measured: Baseline and 24 weeks
Percentage of patients that achieve the minimally important difference in ACQ-7
Percentage of patients that achieve the minimally important difference in ACQ-7 (reduction of at least 0.5 ponints) at week 24
Measured: Baseline and 24 weeks
Change from baseline in eosinophil count in peripheral blood.
Change from baseline in eosinophil count in peripheral blood at week 24.
Measured: Baseline and 24 weeks
Change from baseline in lung function (FEV1).
Change from baseline in lung function (FEV1) at week 24.
Measured: Baseline and 24 weeks
Number of severe exacerbations of asthma.
Number of severe exacerbations of asthma during the 24 weeks of the study.
Measured: 24 weeks
Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ) score.
Change from baseline in the AQLQ questionnaire score at week 24.
Measured: Baseline and 24 weeks
Change from baseline in exhaled nitric oxide levels.
Change from baseline in exhaled nitric oxide levels at week 24.
Measured: Baseline and 24 weeks
Number of participants with adverse events
Number of participants with adverse events
Measured: 24 weeks
Number of participants with severe adverse events
Number of participants with severe adverse events
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start20 Apr 2017
- Primary completion26 Mar 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Sponsor
- Investigators
- Luis Pérez de Llano, MD, Study director, Hospital Universitario Lucus Augusti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074942
- Sponsor's protocol ID
- SEP-RES-2016-01
- Status last verified
- May 2018
- First submitted
- 28 Feb 2017
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reslizumab in Patients With Severe Asthma Who Failed to Respond to Omalizumab: a Pilot Study
- ClinicalTrials.gov ID
- NCT03074942
- Acronym / sponsor ID
- SEP-RES-2016-01
- Conditions
- Severe Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 9 Mar 2017 (actual)
- 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.
Approximately, 5% of the patients with asthma suffer a difficult-to-control severe variant of the disease. Despite being treated with inhaled corticosteroids (ICs), long-acting β2-agonists (LABA), oral corticosteroids or omalizumab, one or more components of the control concept (symptoms, exacerbations, bronchial obstruction) remain to be resolved. Omalizumab has been proven to safely reduce asthma exacerbations and to decease symptoms and quality of life in severe allergic asthmatics. However, approximately 25% of the treated patients fail to respond to this monoclonal antibody. The rest of them show different degrees of response, although the rate of asthmatics who achieve control of the disease is unknown because clinical trials of omalizumab have been carried out to assess the impact of the drug on exacerbations, symptoms or even pulmonary function, but its effect on control was not evaluated. Therefore, there is a need to find new therapeutic options for those severe asthmatics who remain uncontrolled despite having received all the recommended therapies (including omalizumab). Reslizumab is a humanized anti-interleukin-5 (IL-5) monoclonal antibody (mAb) that has been recently found to reduce exacerbations and to improve pulmonary function and symptoms in patients with severe asthma and high peripheral eosinophil counts. It would be important to demonstrate that Reslizumab is able to improve the clinical condition of severe asthma patients with no therapeutic options.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reslizumab | Experimental | Drug: ReslizumabReslizumab 3 mg/kg once / every 4 weeks during 24 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients between 18 and 70 years of age,
- Patients diagnosed with severe uncontrolled asthma
- Patients who give informed consent.
- Previous treatment with omalizumab that was discontinued because lack of efficacy (symptoms -ACT <20, exacerbations) or adverse effects.
- Patients with a high blood eosinophil count (400 μl) at least once in the previous 3 years.
Key exclusion criteria (15 listed)
- Diagnosis of asthma-COPD (Chronic Obstructive Pulmonary Disease) overlap syndrome.
- Active and former smokers of>10 packages / year.
- Exacerbations during the previous 4 weeks.
- Current treatment with omalizumab or last dose of omalizumab in the 5 months prior to inclusion of the patient in the study. 5- Exposure to another monoclonal antibody.
- Participation in another clinical trial.
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 |
|---|---|---|
| ReslizumabReslizumab 3 mg/kg once / every 4 weeks during 24 weeks | Drug | Reslizumab |
Primary outcome
Change from baseline in Asthma Control Test score (ACT)
Time frame: Baseline and 24 weeks
Change in Asthma Control Test score (ACT) between baseline and week 24.
11 secondary outcomes
Change from baseline in Asthma Control Test (ACT) score
Time frame: Baseline and 12 weeks
Change from baseline in the 7-item Asthma Control Questionnaire (ACQ).
Time frame: Baseline and 24 weeks
Percentage of patients that achieve the minimally important difference in ACT
Time frame: Baseline and 24 weeks
Percentage of patients that achieve the minimally important difference in ACQ-7
Time frame: Baseline and 24 weeks
Change from baseline in eosinophil count in peripheral blood.
Time frame: Baseline and 24 weeks
Change from baseline in lung function (FEV1).
Time frame: Baseline and 24 weeks
Number of severe exacerbations of asthma.
Time frame: 24 weeks
Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ) score.
Time frame: Baseline and 24 weeks
Change from baseline in exhaled nitric oxide levels.
Time frame: Baseline and 24 weeks
Number of participants with adverse events
Time frame: 24 weeks
Number of participants with severe adverse events
Time frame: 24 weeks
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 16 May 2018.
- Individual participant dataSharing planned: No
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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.
Luis Pérez de Llano, MD study director
Hospital Universitario Lucus Augusti
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Reslizumab in people with Severe Asthma, run by Sociedad Española de Neumología y Cirugía Torácica at 10 sites in Spain.
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 8 inclusion and 15 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 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Change from baseline in Asthma Control Test score (ACT) (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2018.