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

NCT01567280 | Completed DMC

• 1 other identifier: DFIDM-1101
• Study Type: observational
• Target: 8,111
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Asthma Control Questionnaire score

  3 months

• Mini Asthma Quality of Life Questionnaire score

  3 months

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Written informed consent obtained.
• 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.
• Patients in treatment with the same antiasthmatic drugs in the last 4 weeks before enrolment.

You may not qualify if:

• Patients enrolled in clinical trial in the previous 4 weeks or subjects already admitted in this study.
• Patients suffering from conditions and illnesses that might interfere with the study purpose, according to the investigator's evaluation.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Azienda Sanitaria Firenze Piero Palagi

Florence, 50125, Italy

Location

Related Publications (2)

• 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.

  PMID: 23530817 BACKGROUND

• 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.

  PMID: 27179604 RESULT

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: March 30, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2014
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

IT (1)