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

NCT01426893 | Completed

• 1 other identifier: NIS-RRS-XXX-2011/1
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 5

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).

Conditions

Asthma,; Chronic Obstructive Pulmonary Disease

Keywords

Respiratory disease; COPD

Outcome Measures

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

  12 weeks

Secondary Outcomes (4)

• 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

• 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

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

  12 weeks

• Collection of local demographics data in patients with asthma or COPD

  12 weeks

Study Arms (1)

1

The inhaler device usage in patients with asthma or COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Speciality care clinics

You may qualify if:

• Provision of subject informed consent
• Females or males aged \> 18 years

You may not qualify if:

• \- If participating in any other clinical trial, the subject cannot take part in this study

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (5)

Research Site

Belgrade, Serbia

Location

Research Site

Kamenitz, Serbia

Location

Research Site

Kragujevac, Serbia

Location

Research Site

Niš, Serbia

Location

Research Site

Sombor, Serbia

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Respiration Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Predrag Rebic, Prof.dr

  Clinical Center of Serbia, Belgrade

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2011
• First Posted: September 1, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 29, 2012

Record last verified: 2012-03

Locations

SE (5)