AsthmaNCT02552472
A Study of Inhaler Use in the Community
An observational study of Asthma and Chronic Obstructive Pulmonary Disease, run by Beaumont Hospital at 1 site in Ireland.
Trial summary
This is a prospective cohort observational study of inhaler adherence in a community care setting (ie. general practice clinics and pharmacies in the community). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease, Airways Disease
- How many people
- 150 participants
- Where
- 1 siteIreland
- Study dates
- Aug 2012to Oct 2015
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be a random sample of patients with a known history of respiratory illness and already prescribed a salmeterol/fluticosone Diskus inhaler. Patients will be identified in both community pharmacy centres and general practice clinics within Ireland.
Who may be able to join
- Known history of Respiratory Illness
- Prescribed salmeterol/fluticasone Diskus Inhaler
Who cannot join
- Unable to understand study protocol
- Refusal to sign consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Haphazard and Careless Use of Inhalers, an Observational Study
This is a prospective cohort observational study of inhaler adherence in a community care setting (ie. general practice clinics and pharmacies in the community).
Read the detailed description
Over a 2-4 week period, consecutive patients with a history of respiratory illness already prescribed a salmeterol/fluticasone Diskus inhaler will be asked to participate in this study. Patients will give informed consent to participate in this study of adherence, which will be assessed with the INCA device. Both clinicians and patients will be fully aware that the device is an acoustic recording device and that both time and technique of inhaler use will be assessed. Once consented, patients will be given an INCA enabled inhaler for 1 month and asked to use it as they normally would and then to return it at the end of one month. The days used and the number of doses used in the study period, as per the dose counter, will also be recorded.
- Keywords
- Asthma, Inhaler Use, Adherence, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhaler Adherence in Time
This is adherence as measured by the INCA device in regards to time of use. This is measured as a rate of use.
Measured: One month
Inhaler Technique Adherence
This is adherence measured by the INCA device in regards to technique of use. This is measured as a rate.
Measured: One Month
Secondary outcomes (9)
Age Measured in Years at time of recruitment
Relationship of Age to Adherence
Measured: one month
Gender Measured as Male or Female
Relationship of Gender to Adherence
Measured: One Month
Education Level Measured as either primary, secondary or tertiary school at recruitment.
Relationship of Education Level (Primary/Secondary/Tertiary) to Adherence
Measured: One Month
Socio-economic Class Measured as the patient having either Private or Public Health Insurance
Relationship of Socio-economic class (Private or Public Health Insurance) to Adherence
Measured: One Month
Health Care Use Measured as the number of visits to a General Practitioner in the previous Year
Relationship of Health Care Use (Frequency of visit to General Practitioner) to Adherence
Measured: Previous Year
Hospitalisation Measured as the number of hospital admissions in the previous year
Relationship of Hospitalisation in the prevoius year to Adherence
Measured: Previous Year
Exacerbation Measured as the number of Respiratory Related Exacerbations in the previous year
Relationship of Exacerbation (Respiratory related in the prevoius year) to Adherence
Measured: Previous Year
Background Respiratory Diagnosis, divided into Asthma, COPD and other.
Relationship of Respiratory Diagnosis (Asthma, COPD, other) to Adherence
Measured: Previous History
Smoking History measured by three categories: 1. Current Smoker, 2. Ex-Smoker and 3. Never Smoker
Relationship of Smoking History (Current, Ex-smoker, never smoker) to Adherence
Measured: Previous History
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startAug 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaumont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asthma Society Ireland, Irish Thoracic Society, GlaxoSmithKline, Vitalograph Ireland, Health Research Board, Ireland
- Responsible party
- Principal investigator, Professor Richard Costello, Beaumont Hospital
- Investigators
- Richard W Costello, MD, Principal investigator, RCSI, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552472
- Sponsor's protocol ID
- INCA-CC
- Status last verified
- Jan 2016
- First submitted
- 15 Sep 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haphazard and Careless Use of Inhalers, an Observational Study
- ClinicalTrials.gov ID
- NCT02552472
- Acronym / sponsor ID
- INCA-CC
- Keywords
- Asthma, Inhaler Use, Adherence, Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Collaborators
- Asthma Society Ireland, Irish Thoracic Society, GlaxoSmithKline, Vitalograph Ireland, Health Research Board, Ireland
- Study start
- Aug 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Sep 2015 (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.
This is a prospective cohort observational study of inhaler adherence in a community care setting (ie. general practice clinics and pharmacies in the community).
Detailed description
Over a 2-4 week period, consecutive patients with a history of respiratory illness already prescribed a salmeterol/fluticasone Diskus inhaler will be asked to participate in this study. Patients will give informed consent to participate in this study of adherence, which will be assessed with the INCA device. Both clinicians and patients will be fully aware that the device is an acoustic recording device and that both time and technique of inhaler use will be assessed. Once consented, patients will be given an INCA enabled inhaler for 1 month and asked to use it as they normally would and then to return it at the end of one month. The days used and the number of doses used in the study period, as per the dose counter, will also be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be a random sample of patients with a known history of respiratory illness and already prescribed a salmeterol/fluticosone Diskus inhaler. Patients will be identified in both community pharmacy centres and general practice clinics within Ireland.
Key inclusion criteria (2 listed)
- Known history of Respiratory Illness
- Prescribed salmeterol/fluticasone Diskus Inhaler
Key exclusion criteria (2 listed)
- Unable to understand study protocol
- Refusal to sign consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inhaler Adherence in Time
Time frame: One month
This is adherence as measured by the INCA device in regards to time of use. This is measured as a rate of use.
Inhaler Technique Adherence
Time frame: One Month
This is adherence measured by the INCA device in regards to technique of use. This is measured as a rate.
9 secondary outcomes
Age Measured in Years at time of recruitment
Time frame: one month
Gender Measured as Male or Female
Time frame: One Month
Education Level Measured as either primary, secondary or tertiary school at recruitment.
Time frame: One Month
Socio-economic Class Measured as the patient having either Private or Public Health Insurance
Time frame: One Month
Health Care Use Measured as the number of visits to a General Practitioner in the previous Year
Time frame: Previous Year
Hospitalisation Measured as the number of hospital admissions in the previous year
Time frame: Previous Year
Exacerbation Measured as the number of Respiratory Related Exacerbations in the previous year
Time frame: Previous Year
Background Respiratory Diagnosis, divided into Asthma, COPD and other.
Time frame: Previous History
Smoking History measured by three categories: 1. Current Smoker, 2. Ex-Smoker and 3. Never Smoker
Time frame: Previous History
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 12 Jan 2016.
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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.
Richard W Costello, MD principal investigator
RCSI, Beaumont Hospital
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 Chronic Obstructive Pulmonary Disease, run by Beaumont Hospital at 1 site in Ireland.
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 2 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 12 Jan 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 Ireland. 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?
Inhaler Adherence in Time (time frame: One month). The study lists 2 primary outcomes in all. 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 12 Jan 2016.