AsthmaNCT04665141
Similarities and Differences of Biological Therapies for Severe Asthma.
An observational study of Asthma, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
This is an ambispective multicenter longitudinal observational study to evaluate the efficacy and safety profile of biological therapies in patients diagnosed with severe asthma in real life conditions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- Mepolizumab, Omalizumab and Reslizumab
- How many people
- 600 participants
- Where
- 1 siteSpain
- Study dates
- 7 Apr 2021to Nov 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients, adults and children, with a diagnosis of severe asthma in the participating centers.
Who may be able to join
- Individuals of any age: adults and children.
- Diagnosis of severe asthma as given by the treating physician, and defined as an asthma that remains uncontrolled in despite adherence with maximal optimized therapy and treatment of contributed factors, or asthma that worsens when high dose treatment is decreased.
- Being treated or not (control group) with biological drugs.
- Signed Informed Consent.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Civil-Hospital Regional Universitario de Málaga
Málaga, 29009
Mª José Torres
About this study
This is an ambispective multicenter longitudinal observational study to evaluate the efficacy and safety profile of biological therapies in patients diagnosed with severe asthma in real life conditions.
Read the detailed description
The use of biologicals to treat severe asthma has been implemented in a regular basis while information on long term effectiveness and safety is lacking. It is necessary to establish strategies to closely monitor the possible occurrence of reactions, adverse effects of innovative biological medicines used to treat severe asthma.
In this study the investigators want to evaluate the comparative effectiveness, utilization patterns, long-term safety, and use in special groups in real-life conditions in severe asthma.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepolizumabBiological
Also called Nucala®
Mepolizumab will be prescribed freely by the treating physician according to real-life conditions.
OmalizumabBiological
Also called Xolair®
Omalizumab will be prescribed freely by the treating physician according to real-life conditions.
ReslizumabBiological
Also called Cinqair®
Reslizumab will be prescribed freely by the treating physician according to real-life conditions.
BenralizumabBiological
Also called Fasenra®
Benralizumab will be prescribed freely by the treating physician according to real-life conditions.
DupilumabBiological
Also called Dupixent®
Dupilumab will be prescribed freely by the treating physician according to real-life conditions.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Patients with severe asthma being treated with non-biological standard therapies, mainly systemic corticosteroids. | |
| Biological therapies | Patients with severe asthma being treated with omalizumab, mepolizumab, reslizumab, benralizumab, or dupilumab. Receives: Biological: Mepolizumab; Biological: Omalizumab; Biological: Reslizumab; Biological: Benralizumab; Biological: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment dose scheduling and changes of dose throughout the study.
Measured: 2 years after inclusion
Number of treatment discontinuations and causes of interruption throughout the study.
Measured: 2 years after inclusion
Incidence of Relevant Treatment-Related Adverse Events recorded throughout the study.
Measured: 2 years after inclusion
Severity of Treatment-Related Adverse Events recorded throughout the study.
Measured: 2 years after inclusion
Change of asthma control during the treatment.
Number of asthma exacerbations, change in FEV1, ACT, and blood eosinophilia, need of add-on medication, inhaled medication and systemic corticosteroids.
Measured: 2 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start7 Apr 2021
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Hospital Regional de Malaga
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665141
- Sponsor's protocol ID
- BIO-ALER-2021-01
- Status last verified
- Dec 2020
- First submitted
- 1 Dec 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Similarities and Differences of Biological Therapies for Severe Asthma.
- ClinicalTrials.gov ID
- NCT04665141
- Acronym / sponsor ID
- BIO-ALER-2021-01
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Hospital Regional de Malaga
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 11 Dec 2020 (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.
This is an ambispective multicenter longitudinal observational study to evaluate the efficacy and safety profile of biological therapies in patients diagnosed with severe asthma in real life conditions.
Detailed description
The use of biologicals to treat severe asthma has been implemented in a regular basis while information on long term effectiveness and safety is lacking. It is necessary to establish strategies to closely monitor the possible occurrence of reactions, adverse effects of innovative biological medicines used to treat severe asthma.
In this study the investigators want to evaluate the comparative effectiveness, utilization patterns, long-term safety, and use in special groups in real-life conditions in severe asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | – | –Patients with severe asthma being treated with non-biological standard therapies, mainly systemic corticosteroids. |
| Biological therapies | – | Biological: Mepolizumab, Biological: Omalizumab, Biological: Reslizumab, Biological: Benralizumab, Biological: DupilumabPatients with severe asthma being treated with omalizumab, mepolizumab, reslizumab, benralizumab, or dupilumab. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients, adults and children, with a diagnosis of severe asthma in the participating centers.
Key inclusion criteria (4 listed)
- Individuals of any age: adults and children.
- Diagnosis of severe asthma as given by the treating physician, and defined as an asthma that remains uncontrolled in despite adherence with maximal optimized therapy and treatment of contributed factors, or asthma that worsens when high dose treatment is decreased.
- Being treated or not (control group) with biological drugs.
- Signed Informed Consent.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| MepolizumabAlso: Nucala®Mepolizumab will be prescribed freely by the treating physician according to real-life conditions. | Biological | Biological therapies |
| OmalizumabAlso: Xolair®Omalizumab will be prescribed freely by the treating physician according to real-life conditions. | Biological | Biological therapies |
| ReslizumabAlso: Cinqair®Reslizumab will be prescribed freely by the treating physician according to real-life conditions. | Biological | Biological therapies |
| BenralizumabAlso: Fasenra®Benralizumab will be prescribed freely by the treating physician according to real-life conditions. | Biological | Biological therapies |
| DupilumabAlso: Dupixent®Dupilumab will be prescribed freely by the treating physician according to real-life conditions. | Biological | Biological therapies |
Primary outcome
Treatment dose scheduling and changes of dose throughout the study.
Time frame: 2 years after inclusion
Number of treatment discontinuations and causes of interruption throughout the study.
Time frame: 2 years after inclusion
Incidence of Relevant Treatment-Related Adverse Events recorded throughout the study.
Time frame: 2 years after inclusion
Severity of Treatment-Related Adverse Events recorded throughout the study.
Time frame: 2 years after inclusion
Change of asthma control during the treatment.
Time frame: 2 years after inclusion
Number of asthma exacerbations, change in FEV1, ACT, and blood eosinophilia, need of add-on medication, inhaled medication and systemic corticosteroids.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta López de Calle (+34948425600, mlopezdecal@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment dose scheduling and changes of dose throughout the study. (time frame: 2 years after inclusion). The study lists 5 primary outcomes in all. 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 27 Apr 2021.