Clinical trial NCT01567280: International Cross-sectional and Longitudinal Assessment on Asthma Control (Liaison)
Official title: International Cross-sectional and Longitudinal Assessment on Asthma Control (Liaison)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2012-03-30
Enrollment: 8111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asthmatic patients (in treatment with the same antiasthmatic therapy for at least 4 weeks) visiting the centre.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Asthma Control Questionnaire score
timeFrame: 3 months
measure: Mini Asthma Quality of Life Questionnaire score
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Azienda Sanitaria Firenze Piero Palagi
Study officials:
References:
citation: 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.
citation: Braido F, Brusselle G, Guastalla D, Ingrassia E, Nicolini G, Price D, Roche N, Soriano JB, Worth H; LIAISON Study Group. Determinants and impact of suboptimal asthma control in Europe: The INTERNATIONAL CROSS-SECTIONAL AND LONGITUDINAL ASSESSMENT ON ASTHMA CONTROL (LIAISON) study. Respir Res. 2016 May 14;17(1):51. doi: 10.1186/s12931-016-0374-z.