Clinical trial NCT01426893: Observational Study to Evaluate the Correctness of the Use of Inhaler Device in Patients With Asthma or Chronic Obstruct
Official title: Observational Study to Evaluate the Correctness of the Use of Inhaler Device in Patients With Asthma or Chronic Obstruct
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma,
Chronic Obstructive Pulmonary Disease
Keywords: Respiratory disease
COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-09-01
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Speciality care clinics

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

Eligibility criteria: 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

Primary outcomes:
measure: Investigator's evaluation of the correctness of patients' usage of inhaler device in patients with asthma or COPD assesses by investigator/pulmonologist
timeFrame: 12 weeks
Secondary outcomes:
measure: 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'.
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: Evaluation of the influence of practical education of the patients (performed by physician and/or nursing staff) on all above parameters/assessments
timeFrame: 12 weeks
measure: Collection of local demographics data in patients with asthma or COPD
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Research Site
city: Kragujevac
country: Serbia
facility: Research Site
city: Nis
country: Serbia
facility: Research Site
city: Sombor
country: Serbia
facility: Research Site
city: Sremska Kamenica
country: Serbia
facility: Research Site
Study officials:
affiliation: Clinical Center of Serbia, Belgrade
name: Predrag Rebic, Prof.dr
role: PRINCIPAL_INVESTIGATOR
References: