Observational Study to Evaluate the Correctness of the Use of Inhaler Device in Patients With Asthma or Chronic Obstruct

Completed

• Conditions: Asthma,; Chronic Obstructive Pulmonary Disease

• Registration Number: NCT01426893
• Lead Sponsor: AstraZeneca

Brief Summary

The correct use of inhalation devices is an inclusion criterion for all studies comparing inhaled treatments. In real life, however, patients may make many errors with their usual inhalation device, which may negate the benefits observed in clinical trials. In real life, many errors seem to be made, but no wide-scale evaluation has been performed. The correct use of inhalation devices is essential to ensure the effectiveness of the treatment. It has been recently demonstrated that inhaler misuse is associated with decreased asthma control in asthmatics treated with an inhaled corticosteroid. The aim of our observational study was to evaluate the inhaler device usage in patients with asthma or chronic obstructive pulmonary disease (COPD).

Detailed Description

Observational study to evaluate the correctness of the use of inhaler device in patients with asthma or chronic obstruct

Study Timeline

• Study First Submitted: 2011-08-29
• Study First Submitted QC: 2011-08-31
• Study First Posted: 2011-09-01
• Study Start: 2011-10
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

• Provision of subject informed consent
• Females or males aged > 18 years

Exclusion Criteria

• If participating in any other clinical trial, the subject cannot take part in this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Investigator's evaluation of the correctness of patients' usage of inhaler device in patients with asthma or COPD assesses by investigator/pulmonologist	12 weeks

Secondary Outcome Measures

Name	Time	Method
Evaluation of the influence of practical education of the patients (performed by physician and/or nursing staff) on all above parameters/assessments	12 weeks
Global assessment of disease control, done by investigator. Investigator will globally assess the disease control by one on three categories: 'fully controlled', 'partially controlled', 'uncontrolled'.	12 weeks
Collection of local demographics data in patients with asthma or COPD	12 weeks
Evaluation of patients' perception of the inhaler device and their perspective of symptom control and impact on daily life, by using the patient's questionnaire	12 weeks

Trial Locations

Locations (1)

Research Site; 🇷🇸 Sremska Kamenica, Serbia