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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426893
• Other study ID #: NIS-RRS-XXX-2011/1
• Status: Completed
• Phase: N/A
• First received: August 29, 2011
• Last updated: March 28, 2012
• Start date: October 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Clinical Center of Serbia, Belgrade
• Study type: Observational

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Asthma,
• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Serbia	Research Site	Belgrade
Serbia	Research Site	Kragujevac
Serbia	Research Site	Nis
Serbia	Research Site	Sombor
Serbia	Research Site	Sremska Kamenica

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator's evaluation of the correctness of patients' usage of inhaler device in patients with asthma or COPD assesses by investigator/pulmonologist		12 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Evaluation of the influence of practical education of the patients (performed by physician and/or nursing staff) on all above parameters/assessments		12 weeks	No
Secondary	Collection of local demographics data in patients with asthma or COPD		12 weeks	No