AsthmaNCT04203446
Factors Influencing on Correctness of Inhalation Technique.
An observational study of Asthma and COPD, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Asthma and COPD are common chronic diseases of respiratory system. The correct use of inhalers is crucial in terms of efficacy of the treatment, however both asthma and COPD patients quite frequently misuse the inhalers. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Assessment of correctness of inhaling technique
- How many people
- 180 participants
- Where
- 1 sitePoland
- Study dates
- 30 Oct 2019to 30 Jan 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with asthma or COPD treated in hospital or in out-patient clinic will be asked for participating in the study
Who may be able to join
- Informed consent for participating in the study
- Age 18 -85 years
- COPD or asthma diagnosed at least 3 months prior to enrolment
- using of at least one inhaler regularly every day
- using one of the inhalers: Metered Dose Inhalers (MDI), Dry Powder Inhalers (DPI) or Metered Dose Liquid Inhalers (MDLI)
Who cannot join
- Lack of informed consent
- Age <18 years or > 85 years old
- Diagnosis of asthma or COPD shorter than 3 months before enrollment
- Using inhalers unregularly.
- Symptoms of infection 5 days prior to beginning of the study
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
Warsaw, 02-097
About this study
Official title: Assessment of Clinical Factors Influencing on Correctness of Inhalation Technique in Adults With Asthma or COPD.
Asthma and COPD are common chronic diseases of respiratory system. The correct use of inhalers is crucial in terms of efficacy of the treatment, however both asthma and COPD patients quite frequently misuse the inhalers. The objective of this study is to determine the factors influencing the number of inhalation errors committed by asthma and COPD patients when using the inhalers.
In included patients the inhalation technique will be evaluated (by both list of inhalation errors and 4 point scale of proper inhaling) by two observers and the below information will be collected:
- general demographic information and education level
- information concerning time of diagnosis, the previous course of disease, smoking history, number of previous inhalation techniques training, the sources of information about the inhalation technique and adherence to therapy
- Asthma Control Test or COPD Assessment Test (respectively for asthma and COPD)
- assessment of quality of life (St. George's Questionnaire for COPD and Asthma Quality of Life Questionnaire for asthma)
- cognitive functions assessment using Mini-Mental State Examination
- the simplified assessment of vision impairments
- the results of spirometry
Read the detailed description
Asthma and chronic obstructive pulmonary disease (COPD) are common chronic diseases of respiratory system. Asthma affects about 5% of adults in Poland. The inhaling therapy is the cornerstone of asthma treatment, especially inhaled glucocorticosteroids (ICS). The correct use of inhalers is crucial for efficiency of the therapy and reduction of undesirable side effects of medications. COPD is also a common chronic respiratory disease that affects about 10% of adults above 40 years old. The most important action to prevent and to treat COPD is to stop smoking. The main medications used by COPD patients are inhaled bronchodilators. Both asthma and COPD patients misuse the inhalers.
The objective of this study is to determine the factors influencing the number of inhalation errors committed by asthma and COPD patients when using the inhalers.
Patients:
Patients with asthma or COPD treated in hospital or in out-patient clinic will be asked for participating in the study. Power analysis and sample size calculations indicated that a sample size of 215 subjects (with either asthma or COPD) would provide statistical power to detect even weak correlation (r=0.2) assuming error alpha = 0.05, beta = 0.20 and 10% drop out.
Study design
In included patients inhalation technique will be evaluated (by both list of inhalation errors and 4 point scale of proper inhaling) by two observers and the below information will be gathered:
- general demographic information and education level
- information concerning time of diagnosis, the previous course of disease, smoking history, number of previous inhalation techniques training, the sources of information about the inhalation technique and adherence to therapy
- Asthma Control Test and COPD Assessment Test respectively for asthma and COPD
- assessment of quality of life with the disease (St. George's Questionnaire for COPD and Asthma Quality of Life Questionnaire for asthma)
- cognitive functions assessment using Mini-Mental State Examination
- the simplified assessment of vision impairments
- the results of spirometry The main outcome will be correlation between inhalation technique and other above mentioned factors.
Identification of factors influencing the inhaling errors in patients with asthma or COPD will enable to plan the actions to improve the efficiency of inhaler medications use. At the end of the study all patients will be taught how to use their inhalers properly.
- Being tested
- Assessment of correctness of inhaling technique
- Keywords
- inhalation technique
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of correctness of inhaling techniqueOther
Assessment of correctness of inhaling technique in patients with asthma or COPD
| Study group | Role | What they receive |
|---|---|---|
| Adults with asthma or COPD | Adults (18-85 years old) with asthma or COPD diagnosed at least 3 months earlier, who are regularly treated with at least one inhlaer daily Receives: Other: Assessment of correctness of inhaling technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of correctness of inhalation technique
Assessment of correctness of inhalation technique by list of inhalation errors and 4 point scale of proper inhaling and by two observers
Measured: baseline
Secondary outcomes (11)
Assessment of general demographic features
age (years)
Measured: baseline
Assessment of educational level
educational level (basic, secondary, higher)
Measured: baseline
Assessment of general demographic features
smoking history (pack/years)
Measured: baseline
Assessment of asthma or COPD duration
asthma or COPD duration
Measured: baseline
Assessment of asthma or COPD severity
Asthma Control Test score or COPD Assessment Test score respectively for asthma and COPD
Measured: baseline
Assessment of quality of life related to COPD
St. George's Questionnaire score for COPD
Measured: baseline
Assessment of quality of life related to asthma
Asthma Quality of Life Questionnaire score for asthma
Measured: baseline
Assessment of earlier training in inhalation technique
number of earlier trainings in inhalation technique
Measured: baseline
Assessment of patient's adherence
number of days with missed doses of inhaled drugs per month
Measured: baseline
Assesment of basic cognitive function
Mini-Mental State Examination score
Measured: baseline
Assessment of vision impairments
assessment of vision impairments by Snellen vision test boards
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start30 Oct 2019
- Primary completion15 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Dąbrowska, Medical University of Warsaw
- Investigators
- Rafał Krenke, MD,PhD,Prof, Study director, Warsaw Medical Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203446
- Sponsor's protocol ID
- Inhalation technique 1
- Status last verified
- Feb 2023
- First submitted
- 24 Aug 2019
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Laube BL, Janssens HM, de Jongh FH, Devadason SG, Dhand R, Diot P, Everard ML, Horvath I, Navalesi P, Voshaar T, Chrystyn H; European Respiratory Society; International Society for Aerosols in Medicine. What the pulmonary specialist should know about the new inhalation therapies. Eur Respir J. 2011 Jun;37(6):1308-31. doi: 10.1183/09031936.00166410. Epub 2011 Feb 10.
PubMed 21310878Melani AS, Bonavia M, Cilenti V, Cinti C, Lodi M, Martucci P, Serra M, Scichilone N, Sestini P, Aliani M, Neri M; Gruppo Educazionale Associazione Italiana Pneumologi Ospedalieri. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011 Jun;105(6):930-8. doi: 10.1016/j.rmed.2011.01.005. Epub 2011 Mar 2.
PubMed 21367593Normansell R, Kew KM, Mathioudakis AG. Interventions to improve inhaler technique for people with asthma. Cochrane Database Syst Rev. 2017 Mar 13;3(3):CD012286. doi: 10.1002/14651858.CD012286.pub2.
PubMed 28288272Sanchis J, Gich I, Pedersen S; Aerosol Drug Management Improvement Team (ADMIT). Systematic Review of Errors in Inhaler Use: Has Patient Technique Improved Over Time? Chest. 2016 Aug;150(2):394-406. doi: 10.1016/j.chest.2016.03.041. Epub 2016 Apr 7.
PubMed 27060726Usmani OS, Lavorini F, Marshall J, Dunlop WCN, Heron L, Farrington E, Dekhuijzen R. Critical inhaler errors in asthma and COPD: a systematic review of impact on health outcomes. Respir Res. 2018 Jan 16;19(1):10. doi: 10.1186/s12931-017-0710-y.
PubMed 29338792
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Clinical Factors Influencing on Correctness of Inhalation Technique in Adults With Asthma or COPD.
- ClinicalTrials.gov ID
- NCT04203446
- Acronym / sponsor ID
- Inhalation technique 1
- Keywords
- inhalation technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 18 Dec 2019 (actual)
- 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.
Asthma and COPD are common chronic diseases of respiratory system. The correct use of inhalers is crucial in terms of efficacy of the treatment, however both asthma and COPD patients quite frequently misuse the inhalers. The objective of this study is to determine the factors influencing the number of inhalation errors committed by asthma and COPD patients when using the inhalers.
In included patients the inhalation technique will be evaluated (by both list of inhalation errors and 4 point scale of proper inhaling) by two observers and the below information will be collected:
- general demographic information and education level
- information concerning time of diagnosis, the previous course of disease, smoking history, number of previous inhalation techniques training, the sources of information about the inhalation technique and adherence to therapy
- Asthma Control Test or COPD Assessment Test (respectively for asthma and COPD)
- assessment of quality of life (St. George's Questionnaire for COPD and Asthma Quality of Life Questionnaire for asthma)
- cognitive functions assessment using Mini-Mental State Examination
- the simplified assessment of vision impairments
- the results of spirometry
Detailed description
Asthma and chronic obstructive pulmonary disease (COPD) are common chronic diseases of respiratory system. Asthma affects about 5% of adults in Poland. The inhaling therapy is the cornerstone of asthma treatment, especially inhaled glucocorticosteroids (ICS). The correct use of inhalers is crucial for efficiency of the therapy and reduction of undesirable side effects of medications. COPD is also a common chronic respiratory disease that affects about 10% of adults above 40 years old. The most important action to prevent and to treat COPD is to stop smoking. The main medications used by COPD patients are inhaled bronchodilators. Both asthma and COPD patients misuse the inhalers.
The objective of this study is to determine the factors influencing the number of inhalation errors committed by asthma and COPD patients when using the inhalers.
Patients:
Patients with asthma or COPD treated in hospital or in out-patient clinic will be asked for participating in the study. Power analysis and sample size calculations indicated that a sample size of 215 subjects (with either asthma or COPD) would provide statistical power to detect even weak correlation (r=0.2) assuming error alpha = 0.05, beta = 0.20 and 10% drop out.
Study design
In included patients inhalation technique will be evaluated (by both list of inhalation errors and 4 point scale of proper inhaling) by two observers and the below information will be gathered:
- general demographic information and education level
- information concerning time of diagnosis, the previous course of disease, smoking history, number of previous inhalation techniques training, the sources of information about the inhalation technique and adherence to therapy
- Asthma Control Test and COPD Assessment Test respectively for asthma and COPD
- assessment of quality of life with the disease (St. George's Questionnaire for COPD and Asthma Quality of Life Questionnaire for asthma)
- cognitive functions assessment using Mini-Mental State Examination
- the simplified assessment of vision impairments
- the results of spirometry The main outcome will be correlation between inhalation technique and other above mentioned factors.
Identification of factors influencing the inhaling errors in patients with asthma or COPD will enable to plan the actions to improve the efficiency of inhaler medications use. At the end of the study all patients will be taught how to use their inhalers properly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with asthma or COPD | – | Other: Assessment of correctness of inhaling techniqueAdults (18-85 years old) with asthma or COPD diagnosed at least 3 months earlier, who are regularly treated with at least one inhlaer daily |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with asthma or COPD treated in hospital or in out-patient clinic will be asked for participating in the study
Key inclusion criteria (5 listed)
- Informed consent for participating in the study
- Age 18 -85 years
- COPD or asthma diagnosed at least 3 months prior to enrolment
- using of at least one inhaler regularly every day
- using one of the inhalers: Metered Dose Inhalers (MDI), Dry Powder Inhalers (DPI) or Metered Dose Liquid Inhalers (MDLI)
Key exclusion criteria (5 listed)
- Lack of informed consent
- Age <18 years or > 85 years old
- Diagnosis of asthma or COPD shorter than 3 months before enrollment
- Using inhalers unregularly.
- Symptoms of infection 5 days prior to beginning of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of correctness of inhaling techniqueAssessment of correctness of inhaling technique in patients with asthma or COPD | Other | Adults with asthma or COPD |
Primary outcome
Assessment of correctness of inhalation technique
Time frame: baseline
Assessment of correctness of inhalation technique by list of inhalation errors and 4 point scale of proper inhaling and by two observers
11 secondary outcomes
Assessment of general demographic features
Time frame: baseline
Assessment of educational level
Time frame: baseline
Assessment of general demographic features
Time frame: baseline
Assessment of asthma or COPD duration
Time frame: baseline
Assessment of asthma or COPD severity
Time frame: baseline
Assessment of quality of life related to COPD
Time frame: baseline
Assessment of quality of life related to asthma
Time frame: baseline
Assessment of earlier training in inhalation technique
Time frame: baseline
Assessment of patient's adherence
Time frame: baseline
Assesment of basic cognitive function
Time frame: baseline
Assessment of vision impairments
Time frame: baseline
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 21 Feb 2023.
- Results publication: PubMed 21310878Laube BL, Janssens HM, de Jongh FH, Devadason SG, Dhand R, Diot P, Everard ML, Horvath I, Navalesi P, Voshaar T, Chrystyn H; European Respiratory Society; International Society for Aerosols in Medicine. What the pulmonary specialist should know about the new inhalation therapies. Eur Respir J. 2011 Jun;37(6):1308-31. doi: 10.1183/09031936.00166410. Epub 2011 Feb 10.
- Results publication: PubMed 21367593Melani AS, Bonavia M, Cilenti V, Cinti C, Lodi M, Martucci P, Serra M, Scichilone N, Sestini P, Aliani M, Neri M; Gruppo Educazionale Associazione Italiana Pneumologi Ospedalieri. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011 Jun;105(6):930-8. doi: 10.1016/j.rmed.2011.01.005. Epub 2011 Mar 2.
- Results publication: PubMed 28288272Normansell R, Kew KM, Mathioudakis AG. Interventions to improve inhaler technique for people with asthma. Cochrane Database Syst Rev. 2017 Mar 13;3(3):CD012286. doi: 10.1002/14651858.CD012286.pub2.
- Results publication: PubMed 27060726Sanchis J, Gich I, Pedersen S; Aerosol Drug Management Improvement Team (ADMIT). Systematic Review of Errors in Inhaler Use: Has Patient Technique Improved Over Time? Chest. 2016 Aug;150(2):394-406. doi: 10.1016/j.chest.2016.03.041. Epub 2016 Apr 7.
- Results publication: PubMed 29338792Usmani OS, Lavorini F, Marshall J, Dunlop WCN, Heron L, Farrington E, Dekhuijzen R. Critical inhaler errors in asthma and COPD: a systematic review of impact on health outcomes. Respir Res. 2018 Jan 16;19(1):10. doi: 10.1186/s12931-017-0710-y.
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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.
Rafał Krenke, MD,PhD,Prof study director
Warsaw Medical Univeristy
1 site 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 COPD, run by Medical University of Warsaw at 1 site in Poland.
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 5 inclusion and 5 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 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Assessment of correctness of inhalation technique (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04203446, which also lists 5 linked publications.
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 21 Feb 2023.