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Completed

NCT Number: NCT01426893

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

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).

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Key information

Conditions

Asthma, Asthma Bronchial Diseases Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Belgrade, Serbia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Investigator's evaluation of the correctness of patients' usage of inhaler device in patients with asthma or COPD assesses by investigator/pulmonologist

    Time frame: 12 weeks

Secondary outcomes

  1. 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'.

    Time frame: 12 weeks

  2. 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

    Time frame: 12 weeks

  3. Evaluation of the influence of practical education of the patients (performed by physician and/or nursing staff) on all above parameters/assessments

    Time frame: 12 weeks

  4. Collection of local demographics data in patients with asthma or COPD

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 1, 2011
Registry last updated
Mar 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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