AsthmaMISSIONNCT02509130
MISSION Severe Asthma Modern Innovative Solutions to Improve Outcomes in Severe Asthma.
An observational study of Asthma, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
MISSION is a new and novel way of delivering highly specialised asthma care and has the potential to change the way asthma care across the United Kingdom (UK) is delivered as well as services for other long term health conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 92 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Mar 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with uncontrolled or potentially severe asthma identified from GP records by the MISSION team and new referrals to an asthma specialist clinic at Queen Alexandra Hospital between May and August 2014. Study participants for qualitative interview will be recruited from patients who attended MISSION SAAC days and staff who attended MISSION RAAC or SAAC days.
Who may be able to join
- Male or Female, aged 18 years or above.
- Is in one of the following population groups:
- Attended the MISSION RAAC or
- Attended the MISSION SAAC or
- Identified as uncontrolled asthma by record searches and invited to MISSION RAAC but did not attend - 'primary care patients' or
- Has been referred to the specialist asthma clinic at Queen Alexandra Hospital - 'outpatient severe asthma patients' or
- Attended the MISSION RAAC or SAAC as a health care professional
- Participant is willing and able to give informed consent for participation in the study.
Who cannot join
- The patient is unable or unwilling to give consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY
About this study
Official title: MISSION Severe Asthma: Modern Innovative Solutions to Improve Outcomes in Severe Asthma. A Mixed Methods Observational Comparison of Clinical Outcomes in MISSION Versus Current Care Delivery.
MISSION is a new and novel way of delivering highly specialised asthma care and has the potential to change the way asthma care across the United Kingdom (UK) is delivered as well as services for other long term health conditions. The MISSION model is the first model of this type and the current research study aims to evaluate its success and to compare the MISSION service to current care delivery. This will be done in several different ways. The study is a mixed methods evaluation of the new service comparing outcomes before and after the intervention using retrospective data analysis and prospective qualitative interview. A control arm of patients not exposed to, but eligible for, the new intervention will also be included. The study will be conducted at Portsmouth Hospitals National Health Service (NHS) Trust and will recruit patients who attended MISSION clinics, outpatient asthma clinics, staff who attended MISSION clinics in a professional capacity and patients from GP surgeries where MISSION clinics were held who did not attend.
Read the detailed description
Purpose and design
The purpose of the study is to evaluate in detail the clinical and health economic outcomes from the MISSION project. The MISSION clinics combined a new way of delivering asthma care along with actively case finding patients who were not already known to specialist services but who had uncontrolled or at risk asthma.
The aim of the study is to compare the MISSION clinic model outcomes to current clinic model outcomes as well as performing qualitative interviews with patients who attended and staff who took part in the project.The research study was developed by a team from Portsmouth Hospital Trust and the University of Portsmouth including a research fellow, consultant and Professor, research methodologist, qualitative senior lecturer and independent statistician. A patient adviser also reviewed the lay summary and patient information sheets. The study undergoes independent review by another clinician as part of the sponsor process.
The study is also part of an MD project for the University of Portsmouth.
Design:
This is a mixed methods study.
A quantitative analysis of data from patients who attended the MISSION Rapid Access Asthma Clinics (RAAC), patients who attended the MISSION Severe Asthma Assessment Clinics (SAAC), patients who were invited to the RAAC but did not attend and patients who have been referred by their GP to the severe asthma clinic during the same time MISSION was running. The data analysis will include asthma control, hospital admissions, GP appointments, related medical conditions,medications, investigations and assessments done and time between appointments.
A qualitative study will be conducted using telephone interviews with patients who attended the SAAC and health care professionals who took part in the MISSION clinics.
The aim is to recruit:
- 44 MISSION patients (of whom 20 attended both the RAAC and the SAAC),
- 132 patients who were invited to MISSION RAAC but did not attend
- 20 patients referred to the severe asthma clinic at the hospital
- 20 health care professionals who took part in the MISSION clinics
Methodology:
Participants will be approached for consent by post. They will be given time to read the information and return the consent form to the study team. They will be given a contact number to discuss any questions.
Once a participant has consented to the quantitative study there is no further study procedures for the participant. Participants will be asked for consent to collect data from their GP and hospital records for the study. This will be entered onto a form (CRF) against a study number and then into a password protected study database held on a secure server at Portsmouth Hospitals NHS Trust. This data will then be analysed by a statistician and research fellow.
Participants for qualitative interview will have an interview over the telephone lasting 45 minutes to one hour. This will be recorded and transcribed. The participant will be given the transcript to read and correct. The transcripts will then be analysed looking for themes.
- Conditions
- Asthma
- Keywords
- Severe Asthma, Asthma, Specialised Asthma Care, Asthma Care
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who attended RAAC/SAAC. | Patients who have previously attended the Rapid Access Asthma Clinic (RAAC) will be approached for the quantitative study. Patients who went onto the attend the Severe Asthma Assessment Clinics (SAAC) will also be approached for the quantitative and qualitive parts of the study. | |
| Patients eligible for RAAC, but DNA'd | Patients identified by the GP search, who did not attend the previous MISSION clinics will be approached to participate in the quantitative part of the study. | |
| Asthma Outpatients | Patients who are attending outpatient clinics as new referrals will be approached to participate in the quantitative part of the study. | |
| Healthcare Professionals | Healthcare professionals who performed the MISSION RAAC or SAAC will be approached for qualitative interview part of the study only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control as measured by exacerbation frequency for all patients
The primary endpoint is asthma control as measured by exacerbation frequency (defined as deterioration in symptoms requiring ≥30mg prednisolone or equivalent for ≥3 days) for all patients
Measured: 6 months
Secondary outcomes (38)
Short acting bronchodilator (SABA) use
Short acting bronchodilator (SABA) use measured by number of inhalers prescribed in 6 months pre and post MISSION SAAC, RAAC or outpatient clinic.
Measured: 6 months
Exacerbation frequency
Exacerbation frequency (defined as deterioration in symptoms requiring ≥30mg prednisolone or equivalent for ≥3 days) in 6 months pre and post MISSION SAAC, RAAC or outpatient clinic.
Measured: 6 months
Health care usage costs for asthma and number of contacts
Health care usage costs for asthma and number of contacts (GP visits, Emergency Department (ED) or out of hour attendances (OOH), hospital admissions, emergency GP visits) over 6 months pre and post MISSION or outpatient clinic.
Measured: 6 months
Assessment of co-morbidity
Assessment of comorbidity (rhinosinusitis, anxiety and depression, dysfunctional breathing, gastro oesophageal reflux and obstructive sleep apnoea) and method of assessment for MISSION SAAC patients and outpatient severe asthma clinic patients
Measured: 6 months
Assessment of inhaler technique and recommendations for inhaler devices.
Assessment of inhaler technique and recommendations for inhaler devices for MISSION SAAC patients and outpatient severe asthma clinic patients
Measured: 6 months
Smoking cessation advice.
Smoking cessation advice for MISSION SAAC patients and outpatient severe asthma clinic patients
Measured: 6 months
Investigations performed in secondary care
Investigations performed during 6 months in secondary care e.g. full lung function, sputum induction, High-Resolution Computed Tomography (HRCT) chest for MISSION SAAC patients and outpatient severe asthma clinic patients
Measured: 6 months
Time from GP referral to 1st clinic visit
Time from GP referral to 1st clinic visit in secondary care for MISSION SAAC patients and outpatient severe asthma clinic patients
Measured: 6 months
Time between 1st and 2nd visit
Time between 1st and 2nd visit in secondary care for MISSION SAAC patients and outpatient severe asthma clinic patients
Measured: 6 months
Time to appointment with other specialists
Time to appoint with other specialists for asthma related comorbidity where indicated, e.g. dietician, Ear, Nose \& Throat (ENT), physiotherapists, psychologist, CT imaging for MISSION SAAC patients and outpatient severe asthma clinic patients
Measured: 6 months
Fractional Exhaled Nitric Oxide (FeNO) Assessment
Assessment of eosinophilic airways inflammation by FeNO for MISSION SAAC patients and outpatient severe asthma clinic patients
Measured: 6 months
Frequency of non-attendance
The frequency of non-attendance at clinic for MISSION SAAC patients and outpatient severe asthma clinic patients
Measured: 6 months
Severity of co-morbidities
Severity of co-morbidities for MISSION RAAC patients
Measured: 6 months
Frequency of co-morbidities
Frequency of co-morbidities for MISSION RAAC patients
Measured: 6 months
Frequency & type of allergy
Frequency \& type of allergy for MISSION RAAC patients
Measured: 6 months
Measurement of exhaled nitric oxide
Measurement of exhaled nitric oxide for MISSION RAAC patients
Measured: 6 months
Measurement & variation of lung function (Single
Composite measurement \& variation of lung function for MISSION RAAC patients
Measured: 6 months
Frequency and type of additional asthma control medication.
Frequency and type of additional asthma control medication for MISSION RAAC patients
Measured: 6 months
Quality of life
Quality of life as assessed by the Asthma Quality of Life Questionnaire (AQLQ).
Measured: 6 months
Disease control
Disease control as assessed by the Asthma Control Questionnaire (ACQ)
Measured: 6 months
Number of Forced Expiratory Volume at one second (FEV1) / Forced Vital Capacity (FVC) measurements
Number of patients having measurements of FEV1/FVC as a proxy for asthma control and severity in the MISSION RAAC patient and primary care patients
Measured: 6 months
Prescription of SABA's
Prescription of Short Acting Bronchodilators (SABAs) during last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
Measured: 6 months previous
Prescription of SABA's
Prescription of Short Acting Bronchodilators (SABAs) during last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
Measured: Baseline
Prescription of SABA's
Prescription of Short Acting Bronchodilators (SABAs) during last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
Measured: 6 months
Exacerbation rates
Exacerbation rates (defined as deterioration in symptoms requiring ≥30mg prednisolone or equivalent for ≥3 days) during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
Measured: 6 months previous
Exacerbation rates
Exacerbation rates (defined as deterioration in symptoms requiring ≥30mg prednisolone or equivalent for ≥3 days) during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
Measured: Baseline
Exacerbation rates
Exacerbation rates (defined as deterioration in symptoms requiring ≥30mg prednisolone or equivalent for ≥3 days) during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
Measured: 6 months
ED attendances during the last 6 months
Emergency Department (ED) attendances during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
Measured: 6 months previous
Out Of Hours (OOH) contacts during the last 6 months
Out Of Hours (OOH) contacts during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
Measured: 6 months previous
Hospital admissions during the last 6 months
Emergency Department (ED) attendances, Out Of Hours (OOH) contacts and hospital admissions during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
Measured: 6 months previous
ED attendances at baseline
Emergency Department (ED) attendances at baseline for MISSION RAAC and primary care patients.
Measured: Baseline
OOH contacts at baseline
Out Of Hours (OOH) contacts at baseline for MISSION RAAC and primary care patients.
Measured: Baseline
Hospital admissions at baseline
Hospital admissions at baseline for MISSION RAAC and primary care patients.
Measured: Baseline
ED attendances at 6 months.
Emergency Department (ED) attendances at 6 months for MISSION RAAC and primary care patients.
Measured: 6 months
Out Of Hours (OOH) contacts at 6 months
Out Of Hours (OOH) contacts at 6 months for MISSION RAAC and primary care patients.
Measured: 6 months
Hospital admissions during at 6 months
Hospital admissions during at 6 months for MISSION RAAC and primary care patients.
Measured: 6 months
Inhaled steroid doses and usage
Inhaled steroid doses and usage for MISSION RAAC and primary care patients.
Measured: 6 months
sensitivity and specificity of the Primary Care Information Services (PRIMIS) Asthma Audit Tool
The sensitivity and specificity of the PRIMIS Asthma Audit Tool in identifying the patients compared to gold standard specialist assessment and interrogation of primary care records for MISSION RAAC and primary care patients.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2016
- Study completionMar 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.
- 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
- Retrospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Portsmouth
- Responsible party
- Sponsor
- Investigators
- Professor Anoop J Chauhan, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509130
- Sponsor's protocol ID
- PHT/2015/15
- Acronym
- MISSION
- Status last verified
- Sep 2016
- First submitted
- 13 Jul 2015
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hoddinott P, Pill R. Qualitative research interviewing by general practitioners. A personal view of the opportunities and pitfalls. Fam Pract. 1997 Aug;14(4):307-12. doi: 10.1093/fampra/14.4.307.
PubMed 9283852Hoddinott P, Pill R. A review of recently published qualitative research in general practice. More methodological questions than answers? Fam Pract. 1997 Aug;14(4):313-9. doi: 10.1093/fampra/14.4.313.
PubMed 9283853Bulpitt H, Martin PJ. Who am I and what am I doing? Becoming a qualitative research interviewer. Nurse Res. 2010;17(3):7-16. doi: 10.7748/nr2010.04.17.3.7.c7741.
PubMed 20450084Richards H, Emslie C. The 'doctor' or the 'girl from the University'? Considering the influence of professional roles on qualitative interviewing. Fam Pract. 2000 Feb;17(1):71-5. doi: 10.1093/fampra/17.1.71.
PubMed 10673494
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MISSION Severe Asthma: Modern Innovative Solutions to Improve Outcomes in Severe Asthma. A Mixed Methods Observational Comparison of Clinical Outcomes in MISSION Versus Current Care Delivery.
- ClinicalTrials.gov ID
- NCT02509130
- Acronym / sponsor ID
- MISSION / PHT/2015/15
- Conditions
- Asthma
- Keywords
- Severe Asthma, Asthma, Specialised Asthma Care, Asthma Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- University of Portsmouth
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Jul 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.
MISSION is a new and novel way of delivering highly specialised asthma care and has the potential to change the way asthma care across the United Kingdom (UK) is delivered as well as services for other long term health conditions. The MISSION model is the first model of this type and the current research study aims to evaluate its success and to compare the MISSION service to current care delivery. This will be done in several different ways. The study is a mixed methods evaluation of the new service comparing outcomes before and after the intervention using retrospective data analysis and prospective qualitative interview. A control arm of patients not exposed to, but eligible for, the new intervention will also be included. The study will be conducted at Portsmouth Hospitals National Health Service (NHS) Trust and will recruit patients who attended MISSION clinics, outpatient asthma clinics, staff who attended MISSION clinics in a professional capacity and patients from GP surgeries where MISSION clinics were held who did not attend.
Detailed description
Purpose and design
The purpose of the study is to evaluate in detail the clinical and health economic outcomes from the MISSION project. The MISSION clinics combined a new way of delivering asthma care along with actively case finding patients who were not already known to specialist services but who had uncontrolled or at risk asthma.
The aim of the study is to compare the MISSION clinic model outcomes to current clinic model outcomes as well as performing qualitative interviews with patients who attended and staff who took part in the project.The research study was developed by a team from Portsmouth Hospital Trust and the University of Portsmouth including a research fellow, consultant and Professor, research methodologist, qualitative senior lecturer and independent statistician. A patient adviser also reviewed the lay summary and patient information sheets. The study undergoes independent review by another clinician as part of the sponsor process.
The study is also part of an MD project for the University of Portsmouth.
Design:
This is a mixed methods study.
A quantitative analysis of data from patients who attended the MISSION Rapid Access Asthma Clinics (RAAC), patients who attended the MISSION Severe Asthma Assessment Clinics (SAAC), patients who were invited to the RAAC but did not attend and patients who have been referred by their GP to the severe asthma clinic during the same time MISSION was running. The data analysis will include asthma control, hospital admissions, GP appointments, related medical conditions,medications, investigations and assessments done and time between appointments.
A qualitative study will be conducted using telephone interviews with patients who attended the SAAC and health care professionals who took part in the MISSION clinics.
The aim is to recruit:
- 44 MISSION patients (of whom 20 attended both the RAAC and the SAAC),
- 132 patients who were invited to MISSION RAAC but did not attend
- 20 patients referred to the severe asthma clinic at the hospital
- 20 health care professionals who took part in the MISSION clinics
Methodology:
Participants will be approached for consent by post. They will be given time to read the information and return the consent form to the study team. They will be given a contact number to discuss any questions.
Once a participant has consented to the quantitative study there is no further study procedures for the participant. Participants will be asked for consent to collect data from their GP and hospital records for the study. This will be entered onto a form (CRF) against a study number and then into a password protected study database held on a secure server at Portsmouth Hospitals NHS Trust. This data will then be analysed by a statistician and research fellow.
Participants for qualitative interview will have an interview over the telephone lasting 45 minutes to one hour. This will be recorded and transcribed. The participant will be given the transcript to read and correct. The transcripts will then be analysed looking for themes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients who attended RAAC/SAAC. | – | –Patients who have previously attended the Rapid Access Asthma Clinic (RAAC) will be approached for the quantitative study. Patients who went onto the attend the Severe Asthma Assessment Clinics (SAAC) will also be approached for the quantitative and qualitive parts of the study. |
| Patients eligible for RAAC, but DNA'd | – | –Patients identified by the GP search, who did not attend the previous MISSION clinics will be approached to participate in the quantitative part of the study. |
| Asthma Outpatients | – | –Patients who are attending outpatient clinics as new referrals will be approached to participate in the quantitative part of the study. |
| Healthcare Professionals | – | –Healthcare professionals who performed the MISSION RAAC or SAAC will be approached for qualitative interview part of the study only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with uncontrolled or potentially severe asthma identified from GP records by the MISSION team and new referrals to an asthma specialist clinic at Queen Alexandra Hospital between May and August 2014. Study participants for qualitative interview will be recruited from patients who attended MISSION SAAC days and staff who attended MISSION RAAC or SAAC days.
Key inclusion criteria (8 listed)
- Male or Female, aged 18 years or above.
- Is in one of the following population groups:
- Attended the MISSION RAAC or
- Attended the MISSION SAAC or
- Identified as uncontrolled asthma by record searches and invited to MISSION RAAC but did not attend - 'primary care patients' or
Key exclusion criteria (1 listed)
- The patient is unable or unwilling to give consent
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
Asthma control as measured by exacerbation frequency for all patients
Time frame: 6 months
The primary endpoint is asthma control as measured by exacerbation frequency (defined as deterioration in symptoms requiring ≥30mg prednisolone or equivalent for ≥3 days) for all patients
38 secondary outcomes
Short acting bronchodilator (SABA) use
Time frame: 6 months
Exacerbation frequency
Time frame: 6 months
Health care usage costs for asthma and number of contacts
Time frame: 6 months
Assessment of co-morbidity
Time frame: 6 months
Assessment of inhaler technique and recommendations for inhaler devices.
Time frame: 6 months
Smoking cessation advice.
Time frame: 6 months
Investigations performed in secondary care
Time frame: 6 months
Time from GP referral to 1st clinic visit
Time frame: 6 months
Time between 1st and 2nd visit
Time frame: 6 months
Time to appointment with other specialists
Time frame: 6 months
Fractional Exhaled Nitric Oxide (FeNO) Assessment
Time frame: 6 months
Frequency of non-attendance
Time frame: 6 months
Severity of co-morbidities
Time frame: 6 months
Frequency of co-morbidities
Time frame: 6 months
Frequency & type of allergy
Time frame: 6 months
Measurement of exhaled nitric oxide
Time frame: 6 months
Measurement & variation of lung function (Single
Time frame: 6 months
Frequency and type of additional asthma control medication.
Time frame: 6 months
Quality of life
Time frame: 6 months
Disease control
Time frame: 6 months
Number of Forced Expiratory Volume at one second (FEV1) / Forced Vital Capacity (FVC) measurements
Time frame: 6 months
Prescription of SABA's
Time frame: 6 months previous
Prescription of SABA's
Time frame: Baseline
Prescription of SABA's
Time frame: 6 months
Exacerbation rates
Time frame: 6 months previous
Exacerbation rates
Time frame: Baseline
Exacerbation rates
Time frame: 6 months
ED attendances during the last 6 months
Time frame: 6 months previous
Out Of Hours (OOH) contacts during the last 6 months
Time frame: 6 months previous
Hospital admissions during the last 6 months
Time frame: 6 months previous
ED attendances at baseline
Time frame: Baseline
OOH contacts at baseline
Time frame: Baseline
Hospital admissions at baseline
Time frame: Baseline
ED attendances at 6 months.
Time frame: 6 months
Out Of Hours (OOH) contacts at 6 months
Time frame: 6 months
Hospital admissions during at 6 months
Time frame: 6 months
Inhaled steroid doses and usage
Time frame: 6 months
sensitivity and specificity of the Primary Care Information Services (PRIMIS) Asthma Audit Tool
Time frame: 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 27 Sep 2016.
- Background: PubMed 9283852Hoddinott P, Pill R. Qualitative research interviewing by general practitioners. A personal view of the opportunities and pitfalls. Fam Pract. 1997 Aug;14(4):307-12. doi: 10.1093/fampra/14.4.307.
- Background: PubMed 9283853Hoddinott P, Pill R. A review of recently published qualitative research in general practice. More methodological questions than answers? Fam Pract. 1997 Aug;14(4):313-9. doi: 10.1093/fampra/14.4.313.
- Background: PubMed 20450084Bulpitt H, Martin PJ. Who am I and what am I doing? Becoming a qualitative research interviewer. Nurse Res. 2010;17(3):7-16. doi: 10.7748/nr2010.04.17.3.7.c7741.
- Background: PubMed 10673494Richards H, Emslie C. The 'doctor' or the 'girl from the University'? Considering the influence of professional roles on qualitative interviewing. Fam Pract. 2000 Feb;17(1):71-5. doi: 10.1093/fampra/17.1.71.
- Asthma UKLink provided by the sponsor.
- Department of Health - An outcomes strategy for people with chronic obstructive pulmonary disease (COPD) and asthma in EnglandLink provided by the sponsor.
- Five year forward view, NHS EnglandLink provided by the sponsor.
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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.
Professor Anoop J Chauhan principal investigator
Portsmouth Hospitals NHS Trust
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, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
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 8 inclusion and 1 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 27 Sep 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 United Kingdom. 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 control as measured by exacerbation frequency for all patients (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 NCT02509130, 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 27 Sep 2016; AzTrials last refreshed its copy on 7 Nov 2026.