Prediction of Future Risk in Patients With Controlled Asthma

This study is not yet open for participant recruitment.

Verified March 2012 by Hospital Universitario Lucus Augusti

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

ClinicalTrials.gov Identifier:

NCT01565031

First received: March 26, 2012

Last updated: March 27, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 26, 2012

Last Updated Date

March 27, 2012

Start Date ^ICMJE

May 2012

Estimated Primary Completion Date

May 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Loss of asthma control. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Loss of control: Either ACT score ≤ 19 or the development of exacerbation or FEV1 decrease ≥20%.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01565031 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prediction of Future Risk in Patients With Controlled Asthma

Official Title ^ICMJE

A Simple Prognostic Score for Future Risk Assessment in Patients With Controlled Asthma Who Undergo a Step-down Guidelines-based Strategy

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Well-controlled asthmatics who are regularly under the care of Allergy or Pneumology specialists.

Condition ^ICMJE

Asthma

Intervention ^ICMJE

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.

Study Group/Cohort (s)

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).

Intervention: Procedure: Step-wise down-titration according to international guidelines.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

338

Estimated Completion Date

June 2015

Estimated Primary Completion Date

May 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Luis Perez de Llano, Md, PhD

34 982296000

eremos26@hotmail.com

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01565031

Other Study ID Numbers ^ICMJE

HULA

Has Data Monitoring Committee

Responsible Party

Luis Perez de Llano, Hospital Universitario Lucus Augusti

Study Sponsor ^ICMJE

Luis Perez de Llano

Collaborators ^ICMJE

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 ^ICMJE

Principal Investigator:

Luis Perez de Llano, Md, PhD

Servicio Galego de Saude

Information Provided By

Hospital Universitario Lucus Augusti

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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