Obstructive Lung DiseaseInhaliPADNCT03087188
Inhalation Therapy in Ambulant and Hospitalized Patient Using Available Film Sequences From the Internet
An observational study of Obstructive Lung Disease and COPD, run by RWTH Aachen University at 1 site in Germany.
Trial summary
There are different therapy strategies for patients suffering on obstructive lung disease like chronic obstructive pulmonary disease (COPD), and asthma bronchial available. One of these strategies includes inhalative drugs, e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Lung Disease, COPD, Asthma
- What is being tested?
- Utilization of inhalator
- Type of treatment
- Pill or oral medicine
- How many people
- 114 participants
- Where
- 1 siteGermany
- Study dates
- 9 Sep 2015to 15 Mar 2017
- 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
- Adult, Older adult
Study population: Patients in need of inhalative therapy due to obstructive lung disease, COPD, or asthma bronchial
Who may be able to join
- male and female patients indicated for inhalative treatment with ß2-mimetics, inhalative steroids, anticholinergic drugs, or a combination of these drugs
- patient was already trained on how to use the inhalator before participating in the study
- age > 18
- obtained written consent
Who cannot join
- patients who are incapable to consent or are unable to understand the scope of the trial
- patients who indicate that they do not know how to use the inhalator
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
There are different therapy strategies for patients suffering on obstructive lung disease like chronic obstructive pulmonary disease (COPD), and asthma bronchial available. One of these strategies includes inhalative drugs, e.g. ß2-mimetics, anticholinergic drugs, or glucocorticoids, which are indicated often and which can be used with different inhalation devices. Dry powder inhalators, and dosieraerosol are used the most in clinical routine. Further strategies in treating obstructive lung disease are innovative systems like Respimat or systems with liquid inhalation. However, the success of the therapy depends on the correct application technique. In the clinical routine a high error rate was observed. Consequently, the initiative of the German league of respiratory tracts published internet-based film sequences in order to demonstrate how to use an inhalator correctly. These films are available in the internet for everyone and can be watched as often as needed in order to improve technique and facilitate training.
Therefore, in this study we aim to evaluate the following aspects:
- amount of wrong applications in ambulant and hospitalized patients (wrong in terms of lack of knowledge on how to use the inhalator or incorrect utilization)
- amount of correct applications in patients who had first used the inhalator incorrectly but improved technique by watching the film sequences
- evaluation of learning success within 2 weeks to 2 months (follow-up visit in the ambulance)
- Conditions
- Obstructive Lung Disease, COPD, Asthma
- Being tested
- Utilization of inhalator
- Medical subject headings
- Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utilization of inhalatorOther
After written consent patients will be asked whether they know how to use the inhalator and for how long therapy has been already conducted. Patients using the inhalator correctly have completed the study at this point. If patients have demonstrated incorrect use of the inhalator, a film sequence with instructions will be shown via a tablet. The learning success will be assessed subsequently. When patients show correct application, they will be asked to come back for a follow-up visit within 2 to 8 weeks, otherwise they will be retrained by study staff. At the follow-up visit another demonstration evaluation will be performed.
While demonstrating patients will use the inhalator without any drug that could have any medicinal effect on them.
| Study group | Role | What they receive |
|---|---|---|
| Utilization of inhalator | Film sequences will be shown to patients using incorrect application technique in order to improve technique. Learning success will be assessed subsequently and at a follow-up visit after 2-8 weeks Receives: Other: Utilization of inhalator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct utilization of inhalator
Wrong utilization is determined as lack of knowledge on how to use the inhalator or incorrect application
Measured: Day of Screening and follow-up visit (2-8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start9 Sep 2015
- Primary completion15 Mar 2017
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Lung DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Müller, PD Dr. med., Principal investigator, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087188
- Sponsor's protocol ID
- 15-031
- Acronym
- InhaliPAD
- Status last verified
- Mar 2017
- First submitted
- 15 Mar 2017
- Last updated
- 22 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhalation Therapy in Ambulant and Hospitalized Patient Using Available Film Sequences From the Internet
- ClinicalTrials.gov ID
- NCT03087188
- Acronym / sponsor ID
- InhaliPAD / 15-031
- Conditions
- Obstructive Lung Disease, COPD, Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 9 Sep 2015 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 22 Mar 2017 (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.
There are different therapy strategies for patients suffering on obstructive lung disease like chronic obstructive pulmonary disease (COPD), and asthma bronchial available. One of these strategies includes inhalative drugs, e.g. ß2-mimetics, anticholinergic drugs, or glucocorticoids, which are indicated often and which can be used with different inhalation devices. Dry powder inhalators, and dosieraerosol are used the most in clinical routine. Further strategies in treating obstructive lung disease are innovative systems like Respimat or systems with liquid inhalation. However, the success of the therapy depends on the correct application technique. In the clinical routine a high error rate was observed. Consequently, the initiative of the German league of respiratory tracts published internet-based film sequences in order to demonstrate how to use an inhalator correctly. These films are available in the internet for everyone and can be watched as often as needed in order to improve technique and facilitate training.
Therefore, in this study we aim to evaluate the following aspects:
- amount of wrong applications in ambulant and hospitalized patients (wrong in terms of lack of knowledge on how to use the inhalator or incorrect utilization)
- amount of correct applications in patients who had first used the inhalator incorrectly but improved technique by watching the film sequences
- evaluation of learning success within 2 weeks to 2 months (follow-up visit in the ambulance)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Utilization of inhalator | – | Other: Utilization of inhalatorFilm sequences will be shown to patients using incorrect application technique in order to improve technique. Learning success will be assessed subsequently and at a follow-up visit after 2-8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients in need of inhalative therapy due to obstructive lung disease, COPD, or asthma bronchial
Key inclusion criteria (4 listed)
- male and female patients indicated for inhalative treatment with ß2-mimetics, inhalative steroids, anticholinergic drugs, or a combination of these drugs
- patient was already trained on how to use the inhalator before participating in the study
- age > 18
- obtained written consent
Key exclusion criteria (2 listed)
- patients who are incapable to consent or are unable to understand the scope of the trial
- patients who indicate that they do not know how to use the inhalator
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 |
|---|---|---|
| Utilization of inhalatorAfter written consent patients will be asked whether they know how to use the inhalator and for how long therapy has been already conducted. Patients using the inhalator correctly have completed the study at this point. If patients have demonstrated incorrect use of the inhalator, a film sequence with instructions will be shown via a tablet. The learning success will be assessed subsequently. When patients show correct application, they will be asked to come back for a follow-up visit within 2 to 8 weeks, otherwise they will be retrained by study staff. At the follow-up visit another demonstration evaluation will be performed. While demonstrating patients will use the inhalator without any drug that could have any medicinal effect on them. | Other | Utilization of inhalator |
Primary outcome
Correct utilization of inhalator
Time frame: Day of Screening and follow-up visit (2-8 weeks)
Wrong utilization is determined as lack of knowledge on how to use the inhalator or incorrect application
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 22 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
Tobias Müller, PD Dr. med. principal investigator
University Hospital, Aachen
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 Obstructive Lung Disease and COPD, run by RWTH Aachen University at 1 site in Germany.
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 2 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 22 Mar 2017. 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 Germany. 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?
Correct utilization of inhalator (time frame: Day of Screening and follow-up visit (2-8 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 22 Mar 2017.