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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01426893

Enrollment

310

Registered

2011-09-01

Start date

2011-10-31

Completion date

2012-03-31

Last updated

2012-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma,, Chronic Obstructive Pulmonary Disease

Keywords

Respiratory disease, COPD

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

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
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
Evaluation of the influence of practical education of the patients (performed by physician and/or nursing staff) on all above parameters/assessments	12 weeks
Collection of local demographics data in patients with asthma or COPD	12 weeks

Countries

Serbia

Outcome results