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International Cross-sectional and Longitudinal Assessment on Asthma Control (Liaison) (LIAISON)

This study is currently recruiting participants.
Verified May 2013 by Chiesi Farmaceutici S.p.A.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01567280
First received: March 29, 2012
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  Purpose

The study design consists of a cross-sectional survey on the clinical characteristics of patients with asthma and their level of asthma control and current quality of life, and on a prospective evaluation of the rate of switch from the uncontrolled/poorly controlled condition to the status of controlled asthma. Asthma control will be based on the Asthma Control Questionnaire scoring system, that has been fully validated for use in both clinical practice and clinical trials and has strong discriminative properties which means that it can detect small differences between patients with different levels of asthma control and it is very sensitive to within-patient change in asthma control over time.

Quality of life as a reflection of the control of the disease, will also be evaluated by means of the Mini Asthma Quality of Life Questionnaire scoring system.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Cross-sectional and Longitudinal Assessment on Asthma Control (Liaison)

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Asthma Control Questionnaire score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Mini Asthma Quality of Life Questionnaire score [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 8150
Study Start Date: May 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Controlled patients
Asthmatic patients with controlled asthma (according to ACQ score)
Partly controlled/Uncontrolled patients
Patients with partly controlled or uncontrolled asthma (according to ACQ score)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Asthmatic patients (in treatment with the same antiasthmatic therapy for at least 4 weeks) visiting the centre.

Criteria

Inclusion Criteria:

  • Inclusion criteria:

    1. Written informed consent obtained.
    2. Male or female adult (at least 18 years of age) patients with asthma diagnosed (according to GINA guidelines and confirmed by a chest physician) for at least 6 months.
    3. Patients in treatment with the same antiasthmatic drugs in the last 4 weeks before enrolment.

  • Exclusion criteria:

    1. Patients enrolled in clinical trial in the previous 4 weeks or subjects already admitted in this study.
    2. Patients suffering from conditions and illnesses that might interfere with the study purpose, according to the investigator's evaluation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567280

Contacts
Contact: Eleonora Ingrassia 0521279526 ext +39 e.ingrassia@chiesi.com

Locations
Italy
Azienda Sanitaria Firenze Piero Palagi Recruiting
Firenze, Italy, 50125
Principal Investigator: Walter Castellani            
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
  More Information

No publications provided by Chiesi Farmaceutici S.p.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01567280     History of Changes
Other Study ID Numbers: DFIDM-1101
Study First Received: March 29, 2012
Last Updated: May 20, 2013
Health Authority: Austria: Ethikkommission
France: Institutional Ethical Committee
Germany: Ethics Commission
Greece: Ethics Committee
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Poland: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Turkey: Ethics Committee
United Kingdom: Research Ethics Committee
Hungary: Institutional Ethics Committee

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013