AsthmaNCT01565031
Prediction of Future Risk in Patients With Controlled Asthma
An observational study of Asthma, run by Luis Perez de Llano at 1 site in Spain.
Trial summary
The optimal score to predict unfavourable outcome in well-controlled asthma patients who are undergoing a step-wise down-titration of their medication is still lacking. Thus, a study is warranted to prospectively develop a prognostic system -easy to perform (suitable for use in the clinical rather the research… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Step-wise down-titration according to international guidelines.
- Type of treatment
- Surgery or procedure
- How many people
- 338 participants
- Where
- 1 siteSpain
- Study dates
- May 2012to Jun 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Well-controlled asthmatics who are regularly under the care of Allergy or Pneumology specialists.
Who may be able to join
- Adults (age between 18 and 80.
- Asthma under control during the last 3 months.
- Treated with a combination of ICS and long-acting beta-agonist (LABA.
- Classified as "moderate asthma" by their attending physician.
Who cannot join
- Active smoking.
- Pregnancy.
- Treatment with oral corticosteroids, omalizumab or immunotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Simple Prognostic Score for Future Risk Assessment in Patients With Controlled Asthma Who Undergo a Step-down Guidelines-based Strategy
The optimal score to predict unfavourable outcome in well-controlled asthma patients who are undergoing a step-wise down-titration of their medication is still lacking. Thus, a study is warranted to prospectively develop a prognostic system -easy to perform (suitable for use in the clinical rather the research setting)- for asthmatic patients in this clinical setting.
HYPOTHESIS: A simple score system can accurately predict clinical deterioration of asthma in well-controlled patients who are undergoing a step-wise down-titration of their medication according to international guidelines.
Read more
METHODS The investigators designed a prospective, multicenter, observational study at five centers in cities across Spain.
The patients group (N = 225) will be evaluated to produce a clinical prediction rule for loss of control. The investigators will consider the following variables in the risk factor analysis: documented history of previous bronchial obstruction (FEV1/FVC < 70%), coefficient of variation (CV) of morning peak expiratory flow (PEF), history of exacerbations, fraction of exhaled nitric oxide (FENO), Asthma control test (ACT), ACT item 3 and adherence.
The score model will be prospectively validated in an independent set of 113 patients.
- Conditions
- Asthma
- Being tested
- Step-wise down-titration according to international guidelines.
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step-wise down-titration according to international guidelines.Procedure or surgery
The medication will be adjusted according to each patient´s level of control. Depending on the state of control of asthma, the dose will be adjusted up or down (step-up therapy and step-down therapy, respectively) in accordance with GINA.
| Study group | Role | What they receive |
|---|---|---|
| controlled asthmatics, down-titration | Adults (age between 18 and 80) with asthma under control (see definitions) during the last 3 months, treated with a combination of ICS and long-acting beta-agonist (LABA). Receives: Procedure: Step-wise down-titration according to international guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of asthma control.
Loss of control: Either ACT score ≤ 19 or the development of exacerbation or FEV1 decrease ≥20%.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2015 (estimated)
- Study completionJun 2015 (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
- Prospective
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luis Perez de Llano
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Clinic of Barcelona, Hospital Galdakao-Usansolo, Complexo Hospitalario Universitario de A Coruña
- Responsible party
- Sponsor-investigator, Luis Perez de Llano, Hospital Universitario Lucus Augusti
- Investigators
- Luis Perez de Llano, Md, PhD, Principal investigator, Servicio Galego de Saude
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565031
- Sponsor's protocol ID
- HULA
- Status last verified
- Mar 2012
- First submitted
- 26 Mar 2012
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simple Prognostic Score for Future Risk Assessment in Patients With Controlled Asthma Who Undergo a Step-down Guidelines-based Strategy
- ClinicalTrials.gov ID
- NCT01565031
- Acronym / sponsor ID
- HULA
- Conditions
- Asthma
- Keywords
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Luis Perez de LlanoUniversity, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Clinic of Barcelona, Hospital Galdakao-Usansolo, Complexo Hospitalario Universitario de A Coruña
- Study start
- May 2012
- Primary completion
- May 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 28 Mar 2012 (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 optimal score to predict unfavourable outcome in well-controlled asthma patients who are undergoing a step-wise down-titration of their medication is still lacking. Thus, a study is warranted to prospectively develop a prognostic system -easy to perform (suitable for use in the clinical rather the research setting)- for asthmatic patients in this clinical setting.
HYPOTHESIS: A simple score system can accurately predict clinical deterioration of asthma in well-controlled patients who are undergoing a step-wise down-titration of their medication according to international guidelines.
METHODS The investigators designed a prospective, multicenter, observational study at five centers in cities across Spain.
The patients group (N = 225) will be evaluated to produce a clinical prediction rule for loss of control. The investigators will consider the following variables in the risk factor analysis: documented history of previous bronchial obstruction (FEV1/FVC < 70%), coefficient of variation (CV) of morning peak expiratory flow (PEF), history of exacerbations, fraction of exhaled nitric oxide (FENO), Asthma control test (ACT), ACT item 3 and adherence.
The score model will be prospectively validated in an independent set of 113 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| controlled asthmatics, down-titration | – | Procedure: Step-wise down-titration according to international guidelines.Adults (age between 18 and 80) with asthma under control (see definitions) during the last 3 months, treated with a combination of ICS and long-acting beta-agonist (LABA). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Well-controlled asthmatics who are regularly under the care of Allergy or Pneumology specialists.
Key inclusion criteria (4 listed)
- Adults (age between 18 and 80.
- Asthma under control during the last 3 months.
- Treated with a combination of ICS and long-acting beta-agonist (LABA.
- Classified as "moderate asthma" by their attending physician.
Key exclusion criteria (3 listed)
- Active smoking.
- Pregnancy.
- Treatment with oral corticosteroids, omalizumab or immunotherapy.
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 |
|---|---|---|
| Step-wise down-titration according to international guidelines.The medication will be adjusted according to each patient´s level of control. Depending on the state of control of asthma, the dose will be adjusted up or down (step-up therapy and step-down therapy, respectively) in accordance with GINA. | Procedure or surgery | controlled asthmatics, down-titration |
Primary outcome
Loss of asthma control.
Time frame: 12 months
Loss of control: Either ACT score ≤ 19 or the development of exacerbation or FEV1 decrease ≥20%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2012.
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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 Perez de Llano, Md, PhD principal investigator
Servicio Galego de Saude
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 Luis Perez de Llano 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 3 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 28 Mar 2012. 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 Luis Perez de Llano, Md, PhD (34 982296000, eremos26@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of asthma control. (time frame: 12 months). 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 28 Mar 2012.