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Prediction of Future Risk in Patients With Controlled Asthma

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ClinicalTrials.gov Identifier: NCT01565031
Recruitment Status : Unknown
Verified March 2012 by Luis Perez de Llano, Hospital Universitario Lucus Augusti.
Recruitment status was:  Not yet recruiting
First Posted : March 28, 2012
Last Update Posted : March 28, 2012
Sponsor:
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
Information provided by (Responsible Party):
Luis Perez de Llano, Hospital Universitario Lucus Augusti

Brief 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 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.


Condition or disease Intervention/treatment
Asthma Procedure: Step-wise down-titration according to international guidelines.

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Study Type : Observational
Estimated Enrollment : 338 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Simple Prognostic Score for Future Risk Assessment in Patients With Controlled Asthma Who Undergo a Step-down Guidelines-based Strategy
Study Start Date : May 2012
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
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).
Procedure: 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.




Primary Outcome Measures :
  1. Loss of asthma control. [ Time Frame: 12 months ]
    Loss of control: Either ACT score ≤ 19 or the development of exacerbation or FEV1 decrease ≥20%.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Well-controlled asthmatics who are regularly under the care of Allergy or Pneumology specialists.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Active smoking.
  • Pregnancy.
  • Treatment with oral corticosteroids, omalizumab or immunotherapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565031


Contacts
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Contact: Luis Perez de Llano, Md, PhD 34 982296000 eremos26@hotmail.com

Locations
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Spain
Pneumology Service
Lugo, Spain, 27004
Sponsors and Collaborators
Luis Perez de Llano
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
Investigators
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Principal Investigator: Luis Perez de Llano, Md, PhD Servicio Galego de Saude
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Responsible Party: Luis Perez de Llano, MD, PhD., Hospital Universitario Lucus Augusti
ClinicalTrials.gov Identifier: NCT01565031    
Other Study ID Numbers: HULA
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012
Keywords provided by Luis Perez de Llano, Hospital Universitario Lucus Augusti:
Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases