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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01426893
First received: August 29, 2011
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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).


Condition
Asthma,
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Observational Study to Evaluate the Correctness of the Use of Inhaler Device in Patients With Asthma or Chronic Obstruct

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Collection of local demographics data in patients with asthma or COPD [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 310
Study Start Date: October 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
The inhaler device usage in patients with asthma or COPD

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Speciality care clinics

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426893

Locations
Serbia
Research Site
Belgrade, Serbia
Research Site
Kragujevac, Serbia
Research Site
Nis, Serbia
Research Site
Sombor, Serbia
Research Site
Sremska Kamenica, Serbia
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Predrag Rebic, Prof.dr Clinical Center of Serbia, Belgrade
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01426893     History of Changes
Other Study ID Numbers: NIS-RRS-XXX-2011/1
Study First Received: August 29, 2011
Last Updated: March 28, 2012
Health Authority: Serbia: Clinical Center of Serbia, Belgrade

Keywords provided by AstraZeneca:
Respiratory disease
COPD

Additional relevant MeSH terms:
Asthma
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014