Asthma,NCT01426893
Observational Study to Evaluate the Correctness of the Use of Inhaler Device in Patients With Asthma or Chronic Obstruct
An observational study of Asthma, and Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 5 sites in Serbia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma,, Chronic Obstructive Pulmonary Disease
- How many people
- 310 participants
- Where
- 5 sitesSerbia
- Study dates
- Oct 2011to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Speciality care clinics
Who may be able to join
- Provision of subject informed consent
- Females or males aged > 18 years
Who cannot join
- If participating in any other clinical trial, the subject cannot take part in this study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Serbia5 sites
Research Site
Belgrade
Research Site
Kamenitz
Research Site
Kragujevac
Research Site
Niš
Research Site
Sombor
About this study
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).
Read the detailed description
Observational study to evaluate the correctness of the use of inhaler device in patients with asthma or chronic obstruct
- Conditions
- Asthma,, Chronic Obstructive Pulmonary Disease
- Keywords
- Respiratory disease, COPD
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | The inhaler device usage in patients with asthma or COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's evaluation of the correctness of patients' usage of inhaler device in patients with asthma or COPD assesses by investigator/pulmonologist
Measured: 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'.
Measured: 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
Measured: 12 weeks
Evaluation of the influence of practical education of the patients (performed by physician and/or nursing staff) on all above parameters/assessments
Measured: 12 weeks
Collection of local demographics data in patients with asthma or COPD
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma,Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Predrag Rebic, Prof.dr, Principal investigator, Clinical Center of Serbia, Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426893
- Sponsor's protocol ID
- NIS-RRS-XXX-2011/1
- Status last verified
- Mar 2012
- First submitted
- 29 Aug 2011
- Last updated
- 29 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate the Correctness of the Use of Inhaler Device in Patients With Asthma or Chronic Obstruct
- ClinicalTrials.gov ID
- NCT01426893
- Acronym / sponsor ID
- NIS-RRS-XXX-2011/1
- Conditions
- Asthma,, Chronic Obstructive Pulmonary Disease
- Keywords
- Respiratory disease, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Observational study to evaluate the correctness of the use of inhaler device in patients with asthma or chronic obstruct
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –The inhaler device usage in patients with asthma or COPD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Speciality care clinics
Key inclusion criteria (2 listed)
- Provision of subject informed consent
- Females or males aged > 18 years
Key exclusion criteria (1 listed)
- If participating in any other clinical trial, the subject cannot take part in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
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
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
Collection of local demographics data in patients with asthma or COPD
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2012.
Related trials for Asthma,
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
Asthma
RecruitingObservational study
A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
Asthma
RecruitingPhase 3
A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
Asthma
Not yet recruitingPhase 4
Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Predrag Rebic, Prof.dr principal investigator
Clinical Center of Serbia, Belgrade
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, and Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 5 sites in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2012; AzTrials last refreshed its copy on 6 Nov 2026.