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

August 29, 2011
March 28, 2012
October 2011
March 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01426893 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Observational Study to Evaluate the Correctness of the Use of Inhaler Device in Patients With Asthma or Chronic Obstruct
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).

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

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Speciality care clinics

  • Asthma,
  • Chronic Obstructive Pulmonary Disease
Not Provided
1
The inhaler device usage in patients with asthma or COPD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
310
March 2012
March 2012   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Serbia
 
NCT01426893
NIS-RRS-XXX-2011/1
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Predrag Rebic, Prof.dr Clinical Center of Serbia, Belgrade
AstraZeneca
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP