AsthmaNCT02131454
Efficacy of Inhalation Technique Training.
A study testing Inhalation technique training in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Pharmacologic treatment of asthma and COPD is based mainly on inhalations. The aim of the study is to determine if short training of inhalation technique in patients with obstructive diseases may influence the course of asthma and COPD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Inhalation technique training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2013to Aug 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age of 18 - 80 years
- asthma or COPD diagnosed at least 6 months before study enrollment
- everyday usage of at least one of the following: pressured meter dose inhaler (pMDI) or dry powdered inhaler (Aerolizer, Handihaler, Disc or Turbuhaler)
- no other comorbidities that could influence learning of inhalation technique (psychiatric or neurologic disorders)
Who cannot join
- age less than 18 or above 80 years
- lack of informed consent
- asthma or COPD diagnosed less than 6 months prior to screening visit
- coexistence of respiratory diseases other than asthma or COPD
- irregular use (not every day) of at least one inhaled drug
- treatment with inhalers other than: pMDI, Disc, Turbuhaler, Handihaler or Aerolizer
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: Impact of Inhalation Technique Training on the Course of Asthma and Chronic Obstructive Pulmonary Disease (COPD).
Pharmacologic treatment of asthma and COPD is based mainly on inhalations. The aim of the study is to determine if short training of inhalation technique in patients with obstructive diseases may influence the course of asthma and COPD.
Read the detailed description
Both asthma and COPD are common medical problems. Pharmacologic treatment of asthma and COPD is based mainly on inhalations. The inhalation technique is the key factor for effective management of bronchial obstruction. At the same time, a significant proportion of patients with asthma or COPD do not use inhalers properly.
The aim of the study is:
- to analyze the frequency and type of common mistakes in inhalation technique and
- to determine the impact of short individual training of inhalation technique on the course of asthma and COPD.
Fifty patients with asthma and 50 patients with COPD treated in the out-patient clinic or in the Department of Internal Medicine, Pneumonology and Allergology will be enrolled to the study.
The stage of severity (COPD) and control of the disease (asthma), quality of life, proper inhaler intake will be assessed at the study onset and at a second visit after 6 months.
At the second visit all patients will get a short, individual information about the etiology, course and general treatment plan of asthma / COPD. Patients will be randomized into two groups:
- group of patients trained in proper inhalation technique B. group of patients without inhalation technique training Control visits will be held 3 and 6 months after training.
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Being tested
- Inhalation technique training
- Keywords
- asthma and COPD treatment, inhalation techniques, training of inhalation
- 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.
Inhalation technique trainingOther
Training in inhalation technique in asthmatics and COPD patients
| Study group | Role | What they receive |
|---|---|---|
| Education and Inhalation technique training | Experimental | Training in technique of drug inhalation in asthma and COPD patients and education about the role of inhalation therapy in the course of the disease. Receives: Other: Inhalation technique training |
| Education | No intervention | Basic education about asthma and COPD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma or COPD exacerbations
The number and severity of asthma and COPD exacerbations.
Measured: 6 months
Secondary outcomes (1)
Quality of life.
Change from baseline in quality of life questionnaires:
for asthma patients - Asthma Quality of Life Questionnaire for COPD patients - Saint George's Respiratory Questionnaire
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startSep 2013
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131454
- Sponsor's protocol ID
- WUM-TI
- Status last verified
- Nov 2016
- First submitted
- 3 May 2014
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Melani 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 21367593Press VG, Arora VM, Shah LM, Lewis SL, Charbeneau J, Naureckas ET, Krishnan JA. Teaching the use of respiratory inhalers to hospitalized patients with asthma or COPD: a randomized trial. J Gen Intern Med. 2012 Oct;27(10):1317-25. doi: 10.1007/s11606-012-2090-9. Epub 2012 May 17.
PubMed 22592354Al-Showair RA, Tarsin WY, Assi KH, Pearson SB, Chrystyn H. Can all patients with COPD use the correct inhalation flow with all inhalers and does training help? Respir Med. 2007 Nov;101(11):2395-401. doi: 10.1016/j.rmed.2007.06.008. Epub 2007 Jul 12.
PubMed 17629471Dabrowska M, Luczak-Wozniak K, Miszczuk M, Domagala I, Lubanski W, Leszczynski A, Maskey-Warzechowska M, Rubinsztajn R, Hermanowicz-Salamon J, Krenke R. Impact of a Single Session of Inhalation Technique Training on Inhalation Skills and the Course of Asthma and COPD. Respir Care. 2019 Oct;64(10):1250-1260. doi: 10.4187/respcare.06740. Epub 2019 Jun 18.
PubMed 31213572
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inhalation Technique Training on the Course of Asthma and Chronic Obstructive Pulmonary Disease (COPD).
- ClinicalTrials.gov ID
- NCT02131454
- Acronym / sponsor ID
- WUM-TI
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Keywords
- asthma and COPD treatment, inhalation techniques, training of inhalation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 6 May 2014 (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.
Pharmacologic treatment of asthma and COPD is based mainly on inhalations. The aim of the study is to determine if short training of inhalation technique in patients with obstructive diseases may influence the course of asthma and COPD.
Detailed description
Both asthma and COPD are common medical problems. Pharmacologic treatment of asthma and COPD is based mainly on inhalations. The inhalation technique is the key factor for effective management of bronchial obstruction. At the same time, a significant proportion of patients with asthma or COPD do not use inhalers properly.
The aim of the study is:
- to analyze the frequency and type of common mistakes in inhalation technique and
- to determine the impact of short individual training of inhalation technique on the course of asthma and COPD.
Fifty patients with asthma and 50 patients with COPD treated in the out-patient clinic or in the Department of Internal Medicine, Pneumonology and Allergology will be enrolled to the study.
The stage of severity (COPD) and control of the disease (asthma), quality of life, proper inhaler intake will be assessed at the study onset and at a second visit after 6 months.
At the second visit all patients will get a short, individual information about the etiology, course and general treatment plan of asthma / COPD. Patients will be randomized into two groups:
- group of patients trained in proper inhalation technique B. group of patients without inhalation technique training Control visits will be held 3 and 6 months after training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education and Inhalation technique training | Experimental | Other: Inhalation technique trainingTraining in technique of drug inhalation in asthma and COPD patients and education about the role of inhalation therapy in the course of the disease. |
| Education | No intervention | –Basic education about asthma and COPD. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age of 18 - 80 years
- asthma or COPD diagnosed at least 6 months before study enrollment
- everyday usage of at least one of the following: pressured meter dose inhaler (pMDI) or dry powdered inhaler (Aerolizer, Handihaler, Disc or Turbuhaler)
- no other comorbidities that could influence learning of inhalation technique (psychiatric or neurologic disorders)
Key exclusion criteria (6 listed)
- age less than 18 or above 80 years
- lack of informed consent
- asthma or COPD diagnosed less than 6 months prior to screening visit
- coexistence of respiratory diseases other than asthma or COPD
- irregular use (not every day) of at least one inhaled drug
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 |
|---|---|---|
| Inhalation technique trainingTraining in inhalation technique in asthmatics and COPD patients | Other | Education and Inhalation technique training |
Primary outcome
Asthma or COPD exacerbations
Time frame: 6 months
The number and severity of asthma and COPD exacerbations.
1 secondary outcome
Quality of life.
Time frame: baseline, 3 months, 6 months
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 30 Nov 2016.
- Background: 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.
- Background: PubMed 22592354Press VG, Arora VM, Shah LM, Lewis SL, Charbeneau J, Naureckas ET, Krishnan JA. Teaching the use of respiratory inhalers to hospitalized patients with asthma or COPD: a randomized trial. J Gen Intern Med. 2012 Oct;27(10):1317-25. doi: 10.1007/s11606-012-2090-9. Epub 2012 May 17.
- Background: PubMed 17629471Al-Showair RA, Tarsin WY, Assi KH, Pearson SB, Chrystyn H. Can all patients with COPD use the correct inhalation flow with all inhalers and does training help? Respir Med. 2007 Nov;101(11):2395-401. doi: 10.1016/j.rmed.2007.06.008. Epub 2007 Jul 12.
- Derived from this study: PubMed 31213572Dabrowska M, Luczak-Wozniak K, Miszczuk M, Domagala I, Lubanski W, Leszczynski A, Maskey-Warzechowska M, Rubinsztajn R, Hermanowicz-Salamon J, Krenke R. Impact of a Single Session of Inhalation Technique Training on Inhalation Skills and the Course of Asthma and COPD. Respir Care. 2019 Oct;64(10):1250-1260. doi: 10.4187/respcare.06740. Epub 2019 Jun 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhalation technique training in people with Asthma and Chronic Obstructive Pulmonary Disease, 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 4 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 30 Nov 2016. 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?
Asthma or COPD exacerbations (time frame: 6 months). 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 NCT02131454, which also lists 4 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 30 Nov 2016.