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

Completed

• Conditions: Asthma

• Registration Number: NCT01567280
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-03-29
• Study First Posted: 2012-03-30
• Study Start: 2012-05
• Primary Completion: 2013-10
• Study Completion: 2014-10
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8111

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mini Asthma Quality of Life Questionnaire score	3 months
Asthma Control Questionnaire score	3 months

Trial Locations

Locations (1)

Azienda Sanitaria Firenze Piero Palagi; 🇮🇹 Firenze, Italy