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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01567280
First received: March 29, 2012
Last updated: January 19, 2015
Last verified: January 2015

March 29, 2012
January 19, 2015
May 2012
October 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01567280 on ClinicalTrials.gov Archive Site
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International Cross-sectional and Longitudinal Assessment on Asthma Control (Liaison)
International Cross-sectional and Longitudinal Assessment on Asthma Control (Liaison)

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Asthmatic patients (in treatment with the same antiasthmatic therapy for at least 4 weeks) visiting the centre.
Asthma
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  • 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)
Braido F, Brusselle G, Ingrassia E, Nicolini G, Price D, Roche N, Soriano JB, Worth H; LIAISON study group.. InternationaL cross-sectIonAl and longItudinal assessment on aSthma cONtrol in European adult patients--the LIAISON study protocol. BMC Pulm Med. 2013 Mar 25;13:18. doi: 10.1186/1471-2466-13-18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8111
October 2014
October 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01567280
DFIDM-1101
Yes
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Chiesi Farmaceutici S.p.A.
Chiesi Farmaceutici S.p.A.
Not Provided
Not Provided
Chiesi Farmaceutici S.p.A.
January 2015

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