Chronic AsthmaNCT02386722
Intervention to Improve Inhalative Adherence
A study testing Electronic Monitoring with audio reminders and additional support in people with Chronic Asthma and COPD, run by Cantonal Hospital, Baselland at 2 sites in Switzerland.
Trial summary
Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among asthma and COPD patients is high and patients may be frequently hospitalized due to exacerbations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Asthma, COPD
- What is being tested?
- Electronic Monitoring with audio reminders and additional support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jan 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Aged 18 years or older
- Have an established asthma-diagnosis according to the Global Initiative for Asthma (GINA) guidelines and/or
- Have an established COPD diagnosis according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (severity GOLD I-IV based on the international GOLD-Criteria) [46] and
- Are prescribed daily inhaled medication (controller medication for a daily maintenance treatment)
- Had at least one exacerbation in the previous 12 months before study start
- With a metered dose Inhaler (e.g. Ventolin®), Diskus (e.g.Seretide®), Turbohaler (e.g.Symbicort®), Aerolizer/Breezhaler (e.g.Onbrez®), HandiHaler (e.g. Spiriva®) or Ellipta (e.g Relvar®)
Who cannot join
- Suffering from malignancies and/or other severe diseases
- Insufficient in the German language
- Pregnant or lactating
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Cantonal Hospital Baselland Liestal
Liestal, Basel-Landschaft, 4410
Cantonal Hospital Baselland
Liestal, Basel-Landschaft, 4410
About this study
Official title: Impact of a Pharmaceutical Care Intervention to Improve Adherence of Inhaled Medication in Asthma and COPD Patients
Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among asthma and COPD patients is high and patients may be frequently hospitalized due to exacerbations. Reasons for uncontrolled disease are manifold, but are frequently associated with poor inhalation technique and non-adherence to the prescribed treatment plan which may cause substantial mortality, morbidity, and cost to the healthcare system. In this respect, the study of causes for non-adherence and the development of measures to increase respectively maintain treatment adherence, particularly in chronic diseases, is of major clinical importance.
The aim of this study was to investigate the impact of an acoustic reminder and a close supervision on adherence to inhaled medication and on course of disease and quality of life (Qol) in asthma and COPD patients.
In this single-blinded trial, asthma and/or COPD patients were randomly assigned either to the intervention or the control group. Adherence to inhaled medication was monitored using electronic data capture devices, recording date and time of each inhalation device actuation. Follow-up was six months. Primary outcome was defined as "time to next exacerbation". Secondary outcomes included number of exacerbations, number of exacerbations with hospitalization, taking/timing adherence, and Qol during follow-up. Adherence was measured using electronic data capture devices which saved date and time of each inhalative device actuation. Patients are randomly assigned to an intervention, respectively control group. Patients assigned to the intervention group will receive audio reminder and support calls in case medication is not been taken as prescribed or if rescue medication is used more frequently than prespecified in the study protocol. During the study, participants are assessed every two months.
- Conditions
- Chronic Asthma, COPD
- Being tested
- Electronic Monitoring with audio reminders and additional support
- Keywords
- Adherence of inhaled medication, pharmaceutical intervention
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Monitoring with audio reminders and additional supportDevice
Automated reminder:
-Daily audio-reminder, generated by a smartphone.
Support calls (only patients with Smartinhaler):
- When the use of rescue medication doubles.
- When inhaled medication was not inhaled as prescribed for more than two consecutive days.
Feedback on adherence (only patients with POEMS):
-At every clinical visit (after 2, 4 and 6 months).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participants' smartphones. Patients were allowed to choose the inhalation times themselves. The reminder generated by the by the smartphone had to be quitted by the patients. Patients in the intervention group received support calls carried out by the pharmacist or trained study nurses, when the use of rescue medication doubled or when the medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback on their adherence at each clinical visit, especially for the results of the POEMS. Receives: Device: Electronic Monitoring with audio reminders and additional support |
| Control group | No intervention | Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. Patients assigned to the control group did not receive any reminder or support regarding their adherence to inhaled medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Next Asthma or COPD Exacerbation up to 182 Days
The primary outcome of this study was "time to next asthma or COPD exacerbation", defined as acute-onset worsening of the patient's condition beyond day-to-day variations requiring interaction with a healthcare provider. It was expressed as the number of exacerbations since the last visit with the exact period of exacerbation also including the number of exacerbations requiring hospitalisation. The first exacerbations during the study period served as reference to calculate the primary endpoint "time to next exacerbation".
Measured: 182 days
Secondary outcomes (11)
Number of Exacerbations.
Number of exacerbations during the study period.
Measured: 180 days
Number of Severe Exacerbations.
Exacerbations with the need for hospitalization.
Measured: 180 days
Adherence to Puff Inhalers
Mean duration with Adherence to Puff Inhalers in the Target Range
Measured: 180 days
Percentage of Days With Adherence to Dry Powder Capsules (Breezhaler and Handihaler) Assessed by POEMS
percentage of days with Adherence to Dry Powder Capsules. Taking adherence = [number of puffs inhaled during 24 hours / number of puffs prescribed during 24 hours) x 100. Correct taking adherence was considered when taking adherence was between 80-100%, based on previous studies.
Measured: 180 days
Percentage of Days of Adherence
percentage of days of Adherence for puff inhalers (metered dose inhalers, Turbohaler, Discus, Ellipta) assessed by Smartinhalers.
Measured: 180 days
Percentage of Days With Timing Adherence
percentage of days with timing Adherence for dry powder capsules (Breezhaler, Handihaler), assessed by POEMS
Measured: 180 days
Percentage of Gaps in Puff Inhaler Use
Percentage of Gaps in Puff Inhaler Use Gaps = [number of days without inhalation during the whole study period / number of days in same time period] x 100.
Measured: 180 days
Percentage of Gaps for Dry Powder Capsules (Breezhaler, Handihaler), Assessed by POEMS.
Percentage of Gaps = [number of days without inhalation during the whole study period / number of days in same time period]
Measured: 180 days
Numbers of Days of the Longest Period of Time Without Inhalation During the Investigated Time Period
Maximal gap length = number of consecutive days of the longest period of time without Inhalation during the investigated timeperiod.Assessed by Smartinhalers.
Measured: 180 days
Number of Days of the Longest Period of Time Without Inhalation.
Maximal gap length for dry powder capsules (Breezhaler, Handihaler), Assessed by POEMS = number of consecutive days of the longest period of time without inhalation.
Measured: 180 days
Score of the St. George Respiratory Questionnaire
Score of the St. George Respiratory Questionnaire. Quality of life was assessed using the St. George Respiratory Questionnaire. This is a questionnaire, which was developed for measuring impaired health and perceived well-being in patients with asthma and COPD. Each Subscore ranges from 0-100, higher scores indicate more limitations in one of the 4 domains.
Subscore Symptoms (ranges from 0-100): higher scores indicate worse outcome Subscore Activity (ranges from 0-100): higher scores indicate worse outcome Subscore Impact (ranges from 0-100): higher scores indicate worse outcome
Total Score (ranges from 0-100): higher scores indicate worse outcome. The total score is calculated as a weighted sum of the three subscores. Each questionnaire response has a unique empirically derived 'weight'. The lowest possible weight is zero and the highest is 100.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital, Baselland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel
- Responsible party
- Principal investigator, Prof. Dr. Jörg Leuppi, Cantonal Hospital, Baselland
- Investigators
- Jörg Leuppi, Prof.MD PhD, Principal investigator, 061 925 21 81
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386722
- Sponsor's protocol ID
- 269/13
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2014
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Gregoriano C, Dieterle T, Breitenstein AL, Durr S, Baum A, Giezendanner S, Maier S, Leuppi-Taegtmeyer A, Arnet I, Hersberger KE, Leuppi JD. Does a tailored intervention to promote adherence in patients with chronic lung disease affect exacerbations? A randomized controlled trial. Respir Res. 2019 Dec 3;20(1):273. doi: 10.1186/s12931-019-1219-3.
PubMed 31796013Gregoriano C, Dieterle T, Durr S, Arnet I, Hersberger KE, Leuppi JD. Impact of an Electronic Monitoring Intervention to Improve Adherence to Inhaled Medication in Patients with Asthma and Chronic Obstructive Pulmonary Disease: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Oct 23;6(10):e204. doi: 10.2196/resprot.7522.
PubMed 29061556
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Pharmaceutical Care Intervention to Improve Adherence of Inhaled Medication in Asthma and COPD Patients
- ClinicalTrials.gov ID
- NCT02386722
- Acronym / sponsor ID
- 269/13
- Conditions
- Chronic Asthma, COPD
- Keywords
- Adherence of inhaled medication, pharmaceutical intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Cantonal Hospital, BasellandUniversity, hospital or other
- Collaborators
- University of Basel
- Study start
- Jan 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 12 Mar 2015 (estimated)
- Results
- Posted 4 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among asthma and COPD patients is high and patients may be frequently hospitalized due to exacerbations. Reasons for uncontrolled disease are manifold, but are frequently associated with poor inhalation technique and non-adherence to the prescribed treatment plan which may cause substantial mortality, morbidity, and cost to the healthcare system. In this respect, the study of causes for non-adherence and the development of measures to increase respectively maintain treatment adherence, particularly in chronic diseases, is of major clinical importance.
The aim of this study was to investigate the impact of an acoustic reminder and a close supervision on adherence to inhaled medication and on course of disease and quality of life (Qol) in asthma and COPD patients.
In this single-blinded trial, asthma and/or COPD patients were randomly assigned either to the intervention or the control group. Adherence to inhaled medication was monitored using electronic data capture devices, recording date and time of each inhalation device actuation. Follow-up was six months. Primary outcome was defined as "time to next exacerbation". Secondary outcomes included number of exacerbations, number of exacerbations with hospitalization, taking/timing adherence, and Qol during follow-up. Adherence was measured using electronic data capture devices which saved date and time of each inhalative device actuation. Patients are randomly assigned to an intervention, respectively control group. Patients assigned to the intervention group will receive audio reminder and support calls in case medication is not been taken as prescribed or if rescue medication is used more frequently than prespecified in the study protocol. During the study, participants are assessed every two months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Electronic Monitoring with audio reminders and additional supportThe intervention consisted of an audio-reminder, generated by an app (in case of SmartInhaler devices) or in form of an alarm clock (for the POEMS), and directly transferred to the participants' smartphones. Patients were allowed to choose the inhalation times themselves. The reminder generated by the by the smartphone had to be quitted by the patients. Patients in the intervention group received support calls carried out by the pharmacist or trained study nurses, when the use of rescue medication doubled or when the medication was not inhaled as prescribed for more than two consecutive days. Participants also received a feedback on their adherence at each clinical visit, especially for the results of the POEMS. |
| Control group | No intervention | –Patients in the control group received a Smartinhaler/POEMS, which only records their adherence. Patients assigned to the control group did not receive any reminder or support regarding their adherence to inhaled medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older
- Have an established asthma-diagnosis according to the Global Initiative for Asthma (GINA) guidelines and/or
- Have an established COPD diagnosis according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (severity GOLD I-IV based on the international GOLD-Criteria) [46] and
- Are prescribed daily inhaled medication (controller medication for a daily maintenance treatment)
- Had at least one exacerbation in the previous 12 months before study start
Key exclusion criteria (3 listed)
- Suffering from malignancies and/or other severe diseases
- Insufficient in the German language
- Pregnant or lactating
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 |
|---|---|---|
| Electronic Monitoring with audio reminders and additional supportAutomated reminder: -Daily audio-reminder, generated by a smartphone. Support calls (only patients with Smartinhaler): * When the use of rescue medication doubles. * When inhaled medication was not inhaled as prescribed for more than two consecutive days. Feedback on adherence (only patients with POEMS): -At every clinical visit (after 2, 4 and 6 months). | Device | Intervention group |
Primary outcome
Time to Next Asthma or COPD Exacerbation up to 182 Days
Time frame: 182 days
The primary outcome of this study was "time to next asthma or COPD exacerbation", defined as acute-onset worsening of the patient's condition beyond day-to-day variations requiring interaction with a healthcare provider. It was expressed as the number of exacerbations since the last visit with the exact period of exacerbation also including the number of exacerbations requiring hospitalisation. The first exacerbations during the study period served as reference to calculate the primary endpoint "time to next exacerbation".
11 secondary outcomes
Number of Exacerbations.
Time frame: 180 days
Number of Severe Exacerbations.
Time frame: 180 days
Adherence to Puff Inhalers
Time frame: 180 days
Percentage of Days With Adherence to Dry Powder Capsules (Breezhaler and Handihaler) Assessed by POEMS
Time frame: 180 days
Percentage of Days of Adherence
Time frame: 180 days
Percentage of Days With Timing Adherence
Time frame: 180 days
Percentage of Gaps in Puff Inhaler Use
Time frame: 180 days
Percentage of Gaps for Dry Powder Capsules (Breezhaler, Handihaler), Assessed by POEMS.
Time frame: 180 days
Numbers of Days of the Longest Period of Time Without Inhalation During the Investigated Time Period
Time frame: 180 days
Number of Days of the Longest Period of Time Without Inhalation.
Time frame: 180 days
Score of the St. George Respiratory Questionnaire
Time frame: 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31796013Gregoriano C, Dieterle T, Breitenstein AL, Durr S, Baum A, Giezendanner S, Maier S, Leuppi-Taegtmeyer A, Arnet I, Hersberger KE, Leuppi JD. Does a tailored intervention to promote adherence in patients with chronic lung disease affect exacerbations? A randomized controlled trial. Respir Res. 2019 Dec 3;20(1):273. doi: 10.1186/s12931-019-1219-3.
- Derived from this study: PubMed 29061556Gregoriano C, Dieterle T, Durr S, Arnet I, Hersberger KE, Leuppi JD. Impact of an Electronic Monitoring Intervention to Improve Adherence to Inhaled Medication in Patients with Asthma and Chronic Obstructive Pulmonary Disease: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Oct 23;6(10):e204. doi: 10.2196/resprot.7522.
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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.
Jörg Leuppi, Prof.MD PhD principal investigator
061 925 21 81
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Monitoring with audio reminders and additional support in people with Chronic Asthma and COPD, run by Cantonal Hospital, Baselland at 2 sites in Switzerland.
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 6 inclusion and 3 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 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Yes. Results are posted in the registry (first posted 4 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Next Asthma or COPD Exacerbation up to 182 Days (time frame: 182 days). 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 NCT02386722, which also lists 2 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 4 Mar 2025.