AsthmaCINTECHNCT04349735
Comparison of 3 Methods to Assess Inhalation Technique
A study testing Assessment of inhalation technique in people with Asthma and COPD, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
A significant percentage of patients with asthma and COPD do not use their inhalers properly. Experts recommend that in patients with obstructive lung diseases, inhalation technique and patient adherence should be evaluated at every visit. The assessment of inhalation skills depends on the method of evaluation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Assessment of inhalation technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 10 Oct 2019to 30 Dec 2022
- Phase
- Interventional
- 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
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 enrollment
- 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
- diagnosis of asthma or COPD not earlier than 3 months before enrollment
- using inhalers irregularly.
- symptoms of infection 5 days prior to beginning of the study
- comorbidity that could prevent patient from using Vitalograph®AIM to teach patient proper inhalation technique (i.e. advanced cognitive disorders, mental diseases, crucial neurological, vision or hearing disorders).
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: Comparison of Three Methods of Assessment of INhalation TECHnique in Patients With Asthma and COPD
A significant percentage of patients with asthma and COPD do not use their inhalers properly. Experts recommend that in patients with obstructive lung diseases, inhalation technique and patient adherence should be evaluated at every visit. The assessment of inhalation skills depends on the method of evaluation. There are few different methods of assessment of inhalation technique, however none of them is recommended as the most accurate.
Therefore, the aim of the study is:
Read more
- to compare three different methods of assessment of inhalation technique in patients with asthma and COPD. These methods include:
- Checklist of mistakes in inhalation technique (including critical mistakes)
- 4 grade scale of inhalation technique
- Assessment by Vitalograph®AIM (Aerosol Inhaling Monitor)
- to analyze the influence of Vitalograph®AIM based inhalation technique training on inhalation skills
One hundred and thirty patients with asthma or COPD, who use inhaled medication on a regular basis will be enrolled. Inhalation technique will be evaluated by two observers independently at the same time with all three methods (checklist, 4 grade scale, Vitalograph®AIM). To compare these methods, the investigators will analyze method reliability and validity. Additionally, inhalation technique will be evaluated 30 minutes after Vitalograph®AIM based training to analyze the potential benefit of its application in practicing inhalation skills.
Read the detailed description
Asthma and chronic obstructive pulmonary disease (COPD) are common respiratory diseases. Inhaled therapy is the cornerstone of treatment in these two diseases. However, a significant proportion of patients with asthma and COPD do not use their inhalers properly. Experts recommend that in patients with obstructive lung diseases, inhalation technique and patient adherence should be evaluated at every visit, particularly before introducing changes to the patient's inhalation therapy. The assessment of inhalation skills depends on the method of evaluation. There are few different methods of assessment of inhalation technique, however, none of these methods is recommended as the most accurate.
Therefore, the aim of the study is:
- to compare three different methods of assessment of inhalation technique in patients with asthma and COPD. These methods include:
- Checklist of mistakes in inhalation technique (including critical mistakes)
- 4 grade scale of inhalation technique
- Assessment by Vitalograph®AIM (Aerosol Inhaling Monitor)
- to analyze an influence of using Vitalograph®AIM based inhalation technique training on inhalation skills.
Type of study: prospective, interventional, without randomization. Patients with asthma or COPD treated in hospital or in an out-patient clinic will be asked to participate in the study.
Study design One hundred and thirty patients with asthma or COPD, who use inhaled medication on a regular basis will be enrolled. Inhalation technique will be evaluated by two observers independently at the same time with all three methods (checklist, 4 grade scale, Vitalograph®AIM). To compare these methods, the investigators will analyze method reliability and validity. The reference assessment will be performed by two experienced pulmonologists.
Additionally, inhalation technique will be evaluated 30 minutes after Vitalograph®AIM based training to analyze the potential benefit of its application in practicing inhalation skills.
Outcomes
- Comparison of three different methods of assessment of inhalation technique in patients with asthma and COPD (reliability, validity and accuracy)
- Difference in the number of mistakes made during inhalation before and after the Vitalograph® AIM based training.
Investigators expect that results of this study will allow to identify the most accurate method for assessment of inhalation technique. Furthermore, the impact of Vitalograph®AIM based training on inhalation skills will be assessed..
- Being tested
- Assessment of inhalation 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 inhalation techniqueOther
Assessment of inhalation technique by 3 methods in every patient
| Study group | Role | What they receive |
|---|---|---|
| Adults with asthma or COPD | Experimental | Assessment of inhalation technique by three methods in all patients Receives: Other: Assessment of inhalation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of reliability of assessment of inhalation technique by checklist method in patients with asthma and COPD
Assessment of reliability of checklist method measured by 2 observers by kappa Cohen coefficient
Measured: baseline
Comparison of reliability of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD
Assessment of reliability of 4 grade scale measured by 2 observers by kappa Cohen coefficient
Measured: baseline
Comparison of validity of assessment of inhalation technique by checklist method in patients with asthma and COPD
Assessment of validity of checklist method measured by convergence between observer and an expert baseline by kappa Cohen coefficient
Measured: baseline
Comparison of validity of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD
Assessment of validity of 4 grade scale measured by convergence between observer and an expert baseline by kappa Cohen coefficient
Measured: baseline
Comparison of validity of assessment of inhalation technique by Vitalograph®AIM in patients with asthma and COPD
Assessment of validity of Vitalograph®AIM method (convergence between assessment of Vitalograph®AIM and an expert)
Measured: 30 minutes from baseline
Secondary outcomes (3)
Utility of Vitalograph® AIM in inhalation technique training
Difference in number of inhalation mistakes before and after Vitalograph® AIM based training
Measured: baseline and in 30 minutes
Comparison of repeatability of assessment of inhalation technique by checklist method in patients with asthma and COPD
Assessment of reliability of checklist method measured by 1 observer baseline and in 30 minutes by kappa Cohen coefficient
Measured: baseline and in 30 minutes
Comparison of repeatability of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD
Assessment of reliability of 4 grade scale measured by 1 observer baseline and in 30 minutes by kappa Cohen coefficient
Measured: baseline and in 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start10 Oct 2019
- Primary completion1 Oct 2022
- Study completion30 Dec 2022
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- comparison of three methods of assessment of inhaltion technique
- Masking
- None (open label)
- Enrolment
- 120 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, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349735
- Sponsor's protocol ID
- Inhalation technique 2
- Acronym
- CINTECH
- Status last verified
- Feb 2023
- First submitted
- 16 Dec 2019
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Usmani 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 29338792Laube 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 21367593Sanchis 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 27060726Miszczuk-Ciesla M, Domagala-Manczyk I, Maskey-Warzechowska M, Dabrowska M. Advantages and challenges of training of inhalation technique with the Vitalograph AIM device. Sci Rep. 2026 Jul 22;16(1):27102. doi: 10.1038/s41598-026-62732-8.
PubMed 42665599
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
- Comparison of Three Methods of Assessment of INhalation TECHnique in Patients With Asthma and COPD
- ClinicalTrials.gov ID
- NCT04349735
- Acronym / sponsor ID
- CINTECH / Inhalation technique 2
- Keywords
- inhalation technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 16 Apr 2020 (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.
A significant percentage of patients with asthma and COPD do not use their inhalers properly. Experts recommend that in patients with obstructive lung diseases, inhalation technique and patient adherence should be evaluated at every visit. The assessment of inhalation skills depends on the method of evaluation. There are few different methods of assessment of inhalation technique, however none of them is recommended as the most accurate.
Therefore, the aim of the study is:
- to compare three different methods of assessment of inhalation technique in patients with asthma and COPD. These methods include:
- Checklist of mistakes in inhalation technique (including critical mistakes)
- 4 grade scale of inhalation technique
- Assessment by Vitalograph®AIM (Aerosol Inhaling Monitor)
- to analyze the influence of Vitalograph®AIM based inhalation technique training on inhalation skills
One hundred and thirty patients with asthma or COPD, who use inhaled medication on a regular basis will be enrolled. Inhalation technique will be evaluated by two observers independently at the same time with all three methods (checklist, 4 grade scale, Vitalograph®AIM). To compare these methods, the investigators will analyze method reliability and validity. Additionally, inhalation technique will be evaluated 30 minutes after Vitalograph®AIM based training to analyze the potential benefit of its application in practicing inhalation skills.
Detailed description
Asthma and chronic obstructive pulmonary disease (COPD) are common respiratory diseases. Inhaled therapy is the cornerstone of treatment in these two diseases. However, a significant proportion of patients with asthma and COPD do not use their inhalers properly. Experts recommend that in patients with obstructive lung diseases, inhalation technique and patient adherence should be evaluated at every visit, particularly before introducing changes to the patient's inhalation therapy. The assessment of inhalation skills depends on the method of evaluation. There are few different methods of assessment of inhalation technique, however, none of these methods is recommended as the most accurate.
Therefore, the aim of the study is:
- to compare three different methods of assessment of inhalation technique in patients with asthma and COPD. These methods include:
- Checklist of mistakes in inhalation technique (including critical mistakes)
- 4 grade scale of inhalation technique
- Assessment by Vitalograph®AIM (Aerosol Inhaling Monitor)
- to analyze an influence of using Vitalograph®AIM based inhalation technique training on inhalation skills.
Type of study: prospective, interventional, without randomization. Patients with asthma or COPD treated in hospital or in an out-patient clinic will be asked to participate in the study.
Study design One hundred and thirty patients with asthma or COPD, who use inhaled medication on a regular basis will be enrolled. Inhalation technique will be evaluated by two observers independently at the same time with all three methods (checklist, 4 grade scale, Vitalograph®AIM). To compare these methods, the investigators will analyze method reliability and validity. The reference assessment will be performed by two experienced pulmonologists.
Additionally, inhalation technique will be evaluated 30 minutes after Vitalograph®AIM based training to analyze the potential benefit of its application in practicing inhalation skills.
Outcomes
- Comparison of three different methods of assessment of inhalation technique in patients with asthma and COPD (reliability, validity and accuracy)
- Difference in the number of mistakes made during inhalation before and after the Vitalograph® AIM based training.
Investigators expect that results of this study will allow to identify the most accurate method for assessment of inhalation technique. Furthermore, the impact of Vitalograph®AIM based training on inhalation skills will be assessed..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- comparison of three methods of assessment of inhaltion technique
| Arm | Type | Receives |
|---|---|---|
| Adults with asthma or COPD | Experimental | Other: Assessment of inhalation techniqueAssessment of inhalation technique by three methods in all patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 enrollment
- 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 (6 listed)
- lack of informed consent
- age <18 years or > 85 years
- diagnosis of asthma or COPD not earlier than 3 months before enrollment
- using inhalers irregularly.
- 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 inhalation techniqueAssessment of inhalation technique by 3 methods in every patient | Other | Adults with asthma or COPD |
Primary outcome
Comparison of reliability of assessment of inhalation technique by checklist method in patients with asthma and COPD
Time frame: baseline
Assessment of reliability of checklist method measured by 2 observers by kappa Cohen coefficient
Comparison of reliability of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD
Time frame: baseline
Assessment of reliability of 4 grade scale measured by 2 observers by kappa Cohen coefficient
Comparison of validity of assessment of inhalation technique by checklist method in patients with asthma and COPD
Time frame: baseline
Assessment of validity of checklist method measured by convergence between observer and an expert baseline by kappa Cohen coefficient
Comparison of validity of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD
Time frame: baseline
Assessment of validity of 4 grade scale measured by convergence between observer and an expert baseline by kappa Cohen coefficient
Comparison of validity of assessment of inhalation technique by Vitalograph®AIM in patients with asthma and COPD
Time frame: 30 minutes from baseline
Assessment of validity of Vitalograph®AIM method (convergence between assessment of Vitalograph®AIM and an expert)
3 secondary outcomes
Utility of Vitalograph® AIM in inhalation technique training
Time frame: baseline and in 30 minutes
Comparison of repeatability of assessment of inhalation technique by checklist method in patients with asthma and COPD
Time frame: baseline and in 30 minutes
Comparison of repeatability of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD
Time frame: baseline and in 30 minutes
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.
- Background: 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.
- 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 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.
- Derived from this study: PubMed 42665599Miszczuk-Ciesla M, Domagala-Manczyk I, Maskey-Warzechowska M, Dabrowska M. Advantages and challenges of training of inhalation technique with the Vitalograph AIM device. Sci Rep. 2026 Jul 22;16(1):27102. doi: 10.1038/s41598-026-62732-8.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
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.
Rafał Krenke, MD,PhD,Prof study director
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of inhalation technique in people with 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 6 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?
Comparison of reliability of assessment of inhalation technique by checklist method in patients with asthma and COPD (time frame: baseline). The study lists 5 primary outcomes in all. 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 NCT04349735, 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.