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

Asthma Clinical Trial

— LIAISON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01567280
• Other study ID #: DFIDM-1101
• Status: Completed
• Start date: May 2012
• Est. completion date: October 2014

Study information

• Verified date: July 2020
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8111
• Est. completion date: October 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Italy	Azienda Sanitaria Firenze Piero Palagi	Firenze

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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 ASTHM — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Questionnaire score		3 months
Primary	Mini Asthma Quality of Life Questionnaire score		3 months