Pulmonary Disease, Chronic ObstructiveMISSION-COPDNCT02534766
MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN COPD
An observational study of Pulmonary Disease, Chronic Obstructive, 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 Chronic Obstructive Pulmonary Disease (COPD) care and has the potential to change the way COPD care across the 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
- Pulmonary Disease, Chronic Obstructive
- How many people
- 114 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Aug 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 will be patients who attend MISSION COPD clinics, identified as having uncontrolled or potentially severe COPD or unrecognised COPD from GP records by the MISSION clinical team or health care professionals who attend the clinic in a clinical capacity.
Who may be able to join
- Male of Female, aged 18 years or above.
- Attended the MISSION clinic as a patient.
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 or above.
- Attended the MISSION clinic 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
- The health care professional 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 COPD - Modern Innovative SolutionS in Improving Outcomes iN - COPD - A Comparison of Clinical Outcomes Before and After the MISSION Clinic.
MISSION is a new and novel way of delivering highly specialised Chronic Obstructive Pulmonary Disease (COPD) care and has the potential to change the way COPD care across the UK is delivered as well as services for other long term health conditions. The MISSION model has been piloted in asthma which is the subject of an ongoing research study. This is the first model of this type in COPD and the current research study aims to evaluate the outcomes of the project. 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 clinic using retrospective data analysis and prospective qualitative interview. The study will be conducted at Portsmouth Hospitals NHS Trust and will recruit patients who attend MISSION COPD clinics as well as staff who attended MISSION clinics in a professional capacity.
Read the detailed description
The purpose of the study is to evaluate in detail the clinical and health economic outcomes from the MISSION COPD project. MISSION COPD is a quality improvement project funded by the Health Foundation, Foundation with additional funding from Pfizer, to trial an innovative way of finding and assessing patients with COPD and also case finding new diagnoses of COPD.
MISSION-COPD will allow swift early specialist multi-disciplinary interventions in primary care to diagnose and treat those at greatest risk, consistent with the NHS England '5-year Forward View' calling for removal of traditional primary and secondary care barriers. MISSION COPD will target COPD patients with risk factors for exacerbations and deteriorating lung function as well potential new diagnoses of COPD.
The aim of the study is to review the MISSION clinic model outcomes as well as performing qualitative interviews with patients who attended and staff who took part in the project.
Up to 150 patients who attend the MISSION COPD clinic will be recruited along with approximately 20 health care professionals. The number of patients has been decided as the number that can be seen for the project in the MISSION COPD project time and budget.
Participants will be either:
- Patients who attend MISSION COPD clinics - identified as having uncontrolled or potentially severe COPD or unrecognised COPD from GP records by the MISSION clinical team
- Health care professionals who attend the clinic in a clinical capacity.
Retrospective quantitative analysis of the data collected during the MISSION clinics will be analysed looking for COPD phenotypes and contributing co-morbidities. The data collected at the initial visit and 3 and 6 month follow up questionnaires will be analysed looking for improvement in COPD control and quality of life following the patients' attendance at MISSION clinics.
A self completion questionnaire will be filled in after the clinic by participants in the research study to assess their views on the clinic and where they would like changes to be made. A questionnaire will also be given to health care professionals to seek their views on the clinic.
Qualitative interviews will be conducted with a sample of participants, willing to take part, to explore the experiences and acceptability of the participants and health care professionals. The interviews with health care professionals will explore their thoughts on MISSION and its strengths and weaknesses as well as any suggestions for improvement.
This research is important as it will provide evidence to support the use of the MISSION clinic model for patients with COPD. It will also give us more information on the patient with COPD and any medical conditions related to their COPD so we can adapt our service to meet their needs.
The telephone and group interviews will help us understand what we are doing right and what we are doing wrong with COPD care.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients who attended the MISSION COPD clinics | COPD patients who attended the MISSION COPD clinics, identified as having uncontrolled or potentially severe COPD or unrecognised COPD from GP records by the MISSION clinical team | |
| Health Care Professionals | Health Care Professionals who attended the MISSION COPD clinics in a professional/ clinical capacity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days
To assess whether the number COPD exacerbations (prednisolone or equivalent ≥30 mg for >3 days or antibiotics for >3 days) improves in MISSION patients in the 6 months after the clinic compared with the 6 months before.
Measured: 6 months previous
COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days
To assess whether the number COPD exacerbations (prednisolone or equivalent ≥30 mg for >3 days or antibiotics for >3 days) improves in MISSION patients in the 6 months after the clinic compared with the 6 months before.
Measured: 6 months
Number of exacerbations of COPD that require hospital admission and treatment
Number of exacerbations of COPD that require admission to hospital for treatment to assess whether hospital admissions change in the 6 months after the MISSION clinic
Measured: 6 months previous
Number of exacerbations of COPD that require hospital admission and treatment
Number of exacerbations of COPD that require admission to hospital for treatment to assess whether hospital admissions change in the 6 months after the MISSION clinic
Measured: 6 months
Secondary outcomes (38)
COPD Assessment Test (CAT) Score
patients will complete the CAT questionnaire to assess COPD control
Measured: baseline
COPD Assessment Test (CAT) Score
patients will complete the CAT questionnaire to assess COPD control
Measured: 3 months
COPD Assessment Test (CAT) Score
patients will complete the CAT questionnaire to assess COPD control
Measured: 6 months
St George's Respiratory Questionnaire (SGRQ)
Measured: baseline
St George's Respiratory Questionnaire (SGRQ)
Measured: 3 months
St George's Respiratory Questionnaire (SGRQ)
Measured: 6 months
Number of non elective GP visits for COPD
Number of non elective GP visits for COPD in the 6 months pre MISSION
Measured: 6 month previous
Number of non elective GP visits for COPD
Number of non elective GP visits for COPD in the 6 months post MISSION
Measured: 6 months
Number of hospital admissions for COPD
Number of hospital admissions for COPD in the 6 months pre MISSION
Measured: 6 month previous
Number of hospital admissions for COPD
Number of hospital admissions for COPD in the 6 months post MISSION
Measured: 6 months
Number of Emergency Department contacts for COPD
Number of Emergency Department contacts for COPD in the 6 months pre MISSION
Measured: 6 month previous
Number of Emergency Department contacts for COPD
Number of Emergency Department contacts for COPD in the 6 months post MISSION
Measured: 6 months
Number of out of hour (OOH) attendances/contacts for COPD
Number of out of hour attendances (OOH) contacts for COPD in the 6 months pre MISSION
Measured: 6 month previous
Number of out of hour (OOH) attendances/contacts for COPD
Number of out of hour attendances (OOH) contacts for COPD in the 6 months post MISSION
Measured: 6 months
Global initiative in chronic Obstructive Lung Disease (GOLD) score
To assess the severity of COPD by GOLD and BTS stage in the MISSION clinics
Measured: Baseline
Measurement and variation of lung function.
Measured: Baseline
Assessment of eosinophilic airways inflammation
Assessment of eosinophilic airways inflammation by Fractional Exhaled Nitric Oxide (FeNO) Assessment.
Measured: Baseline
COPD controller medication
COPD controller medication in 6 months pre MISSION.
Measured: 6 months previous
COPD controller medication
COPD controller medication in 6 months post MISSION.
Measured: 6 months
Number of antibiotic courses without prednisolone for lower respiratory tract infections
Number of antibiotic courses without prednisolone for lower respiratory tract infections in 6 months pre MISSION
Measured: 6 months previous
Number of antibiotic courses without prednisolone for lower respiratory tract infections
Number of antibiotic courses without prednisolone for lower respiratory tract infections in 6 months post MISSION
Measured: 6 months
Short acting bronchodilator (SABA) use
Short acting bronchodilator (SABA) use measured by number of inhalers prescribed in 6 months pre MISSION.
Measured: 6 months previous
Short acting bronchodilator (SABA) use
Short acting bronchodilator (SABA) use measured by number of inhalers prescribed in 6 months post MISSION.
Measured: 6 months
Frequency and severity of co-morbidities
Frequency and severity of co morbidities including anxiety and depression, dysfunctional breathing, gastro oesophageal reflux and obstructive sleep apnoea in all patients.
Measured: Baseline
Medication adherence
Medication adherence will be measured at baseline
Measured: Baseline
Medication adherence
Medication adherence will be measured at 3 months
Measured: 3 months
Medication adherence
Medication adherence will be measured at 6 months
Measured: 6 months
Patient activation measure
Patients will complete the patient activation measure questionnaire at Baseline
Measured: Baseline
Patient activation measure
Patients will complete the patient activation measure questionnaire at 3 months
Measured: 3 months
Patient activation measure
Patients will complete the patient activation measure questionnaire at 6 months
Measured: 6 months
Investigations performed
Investigations performed at the MISSION COPD clinics (e.g. sputum induction, High-Resolution Computed Tomography (HRCT) chest).
Measured: Baseline
Hospital Anxiety and Depression Scale (HADS) score
HADS scores at baseline for patients attending the MISSION clinics
Measured: Baseline
Hospital Anxiety and Depression Scale (HADS) score
HADS scores at 6 months for patients attending the MISSION clinics
Measured: 6 months
Gastroesophageal Reflux Disease Questionnaire (GERDQ) score
GERDQ scores at baseline for patients attending the Severe COPD Assessment Clinic (SCAC)
Measured: baseline
Gastroesophageal Reflux Disease Questionnaire (GERDQ) score
GERDQ scores at 6 months for patients attending the Severe COPD Assessment Clinic (SCAC)
Measured: 6 months
Assessment of inhaler technique and recommendations for inhaler devices.
Measured: Baseline
Smoking cessation advice
Measured: Baseline
The frequency of non-attendance at clinic
The frequency of non-attendance at the MISSION clinic
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Professor Anoop J Chauhan, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534766
- Sponsor's protocol ID
- PHT/2015/71
- Acronym
- MISSION-COPD
- Status last verified
- Sep 2016
- First submitted
- 25 Aug 2015
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kruis AL, Smidt N, Assendelft WJ, Gussekloo J, Boland MR, Rutten-van Molken M, Chavannes NH. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2013 Oct 10;(10):CD009437. doi: 10.1002/14651858.CD009437.pub2.
PubMed 24108523Wilkinson T, North M, Bourne SC. Reducing hospital admissions and improving the diagnosis of COPD in Southampton City: methods and results of a 12-month service improvement project. NPJ Prim Care Respir Med. 2014 Aug 21;24(0):14035. doi: 10.1038/npjpcrm.2014.35.
PubMed 25141877
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 COPD - Modern Innovative SolutionS in Improving Outcomes iN - COPD - A Comparison of Clinical Outcomes Before and After the MISSION Clinic.
- ClinicalTrials.gov ID
- NCT02534766
- Acronym / sponsor ID
- MISSION-COPD / PHT/2015/71
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- Pfizer
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 28 Aug 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 Chronic Obstructive Pulmonary Disease (COPD) care and has the potential to change the way COPD care across the UK is delivered as well as services for other long term health conditions. The MISSION model has been piloted in asthma which is the subject of an ongoing research study. This is the first model of this type in COPD and the current research study aims to evaluate the outcomes of the project. 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 clinic using retrospective data analysis and prospective qualitative interview. The study will be conducted at Portsmouth Hospitals NHS Trust and will recruit patients who attend MISSION COPD clinics as well as staff who attended MISSION clinics in a professional capacity.
Detailed description
The purpose of the study is to evaluate in detail the clinical and health economic outcomes from the MISSION COPD project. MISSION COPD is a quality improvement project funded by the Health Foundation, Foundation with additional funding from Pfizer, to trial an innovative way of finding and assessing patients with COPD and also case finding new diagnoses of COPD.
MISSION-COPD will allow swift early specialist multi-disciplinary interventions in primary care to diagnose and treat those at greatest risk, consistent with the NHS England '5-year Forward View' calling for removal of traditional primary and secondary care barriers. MISSION COPD will target COPD patients with risk factors for exacerbations and deteriorating lung function as well potential new diagnoses of COPD.
The aim of the study is to review the MISSION clinic model outcomes as well as performing qualitative interviews with patients who attended and staff who took part in the project.
Up to 150 patients who attend the MISSION COPD clinic will be recruited along with approximately 20 health care professionals. The number of patients has been decided as the number that can be seen for the project in the MISSION COPD project time and budget.
Participants will be either:
- Patients who attend MISSION COPD clinics - identified as having uncontrolled or potentially severe COPD or unrecognised COPD from GP records by the MISSION clinical team
- Health care professionals who attend the clinic in a clinical capacity.
Retrospective quantitative analysis of the data collected during the MISSION clinics will be analysed looking for COPD phenotypes and contributing co-morbidities. The data collected at the initial visit and 3 and 6 month follow up questionnaires will be analysed looking for improvement in COPD control and quality of life following the patients' attendance at MISSION clinics.
A self completion questionnaire will be filled in after the clinic by participants in the research study to assess their views on the clinic and where they would like changes to be made. A questionnaire will also be given to health care professionals to seek their views on the clinic.
Qualitative interviews will be conducted with a sample of participants, willing to take part, to explore the experiences and acceptability of the participants and health care professionals. The interviews with health care professionals will explore their thoughts on MISSION and its strengths and weaknesses as well as any suggestions for improvement.
This research is important as it will provide evidence to support the use of the MISSION clinic model for patients with COPD. It will also give us more information on the patient with COPD and any medical conditions related to their COPD so we can adapt our service to meet their needs.
The telephone and group interviews will help us understand what we are doing right and what we are doing wrong with COPD care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who attended the MISSION COPD clinics | – | –COPD patients who attended the MISSION COPD clinics, identified as having uncontrolled or potentially severe COPD or unrecognised COPD from GP records by the MISSION clinical team |
| Health Care Professionals | – | –Health Care Professionals who attended the MISSION COPD clinics in a professional/ clinical capacity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be patients who attend MISSION COPD clinics, identified as having uncontrolled or potentially severe COPD or unrecognised COPD from GP records by the MISSION clinical team or health care professionals who attend the clinic in a clinical capacity.
Key inclusion criteria (6 listed)
- Male of Female, aged 18 years or above.
- Attended the MISSION clinic as a patient.
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 or above.
- Attended the MISSION clinic as a health care professional
Key exclusion criteria (2 listed)
- The patient is unable or unwilling to give consent
- The health care professional 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
COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days
Time frame: 6 months previous
To assess whether the number COPD exacerbations (prednisolone or equivalent ≥30 mg for >3 days or antibiotics for >3 days) improves in MISSION patients in the 6 months after the clinic compared with the 6 months before.
COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days
Time frame: 6 months
To assess whether the number COPD exacerbations (prednisolone or equivalent ≥30 mg for >3 days or antibiotics for >3 days) improves in MISSION patients in the 6 months after the clinic compared with the 6 months before.
Number of exacerbations of COPD that require hospital admission and treatment
Time frame: 6 months previous
Number of exacerbations of COPD that require admission to hospital for treatment to assess whether hospital admissions change in the 6 months after the MISSION clinic
Number of exacerbations of COPD that require hospital admission and treatment
Time frame: 6 months
Number of exacerbations of COPD that require admission to hospital for treatment to assess whether hospital admissions change in the 6 months after the MISSION clinic
38 secondary outcomes
COPD Assessment Test (CAT) Score
Time frame: baseline
COPD Assessment Test (CAT) Score
Time frame: 3 months
COPD Assessment Test (CAT) Score
Time frame: 6 months
St George's Respiratory Questionnaire (SGRQ)
Time frame: baseline
St George's Respiratory Questionnaire (SGRQ)
Time frame: 3 months
St George's Respiratory Questionnaire (SGRQ)
Time frame: 6 months
Number of non elective GP visits for COPD
Time frame: 6 month previous
Number of non elective GP visits for COPD
Time frame: 6 months
Number of hospital admissions for COPD
Time frame: 6 month previous
Number of hospital admissions for COPD
Time frame: 6 months
Number of Emergency Department contacts for COPD
Time frame: 6 month previous
Number of Emergency Department contacts for COPD
Time frame: 6 months
Number of out of hour (OOH) attendances/contacts for COPD
Time frame: 6 month previous
Number of out of hour (OOH) attendances/contacts for COPD
Time frame: 6 months
Global initiative in chronic Obstructive Lung Disease (GOLD) score
Time frame: Baseline
Measurement and variation of lung function.
Time frame: Baseline
Assessment of eosinophilic airways inflammation
Time frame: Baseline
COPD controller medication
Time frame: 6 months previous
COPD controller medication
Time frame: 6 months
Number of antibiotic courses without prednisolone for lower respiratory tract infections
Time frame: 6 months previous
Number of antibiotic courses without prednisolone for lower respiratory tract infections
Time frame: 6 months
Short acting bronchodilator (SABA) use
Time frame: 6 months previous
Short acting bronchodilator (SABA) use
Time frame: 6 months
Frequency and severity of co-morbidities
Time frame: Baseline
Medication adherence
Time frame: Baseline
Medication adherence
Time frame: 3 months
Medication adherence
Time frame: 6 months
Patient activation measure
Time frame: Baseline
Patient activation measure
Time frame: 3 months
Patient activation measure
Time frame: 6 months
Investigations performed
Time frame: Baseline
Hospital Anxiety and Depression Scale (HADS) score
Time frame: Baseline
Hospital Anxiety and Depression Scale (HADS) score
Time frame: 6 months
Gastroesophageal Reflux Disease Questionnaire (GERDQ) score
Time frame: baseline
Gastroesophageal Reflux Disease Questionnaire (GERDQ) score
Time frame: 6 months
Assessment of inhaler technique and recommendations for inhaler devices.
Time frame: Baseline
Smoking cessation advice
Time frame: Baseline
The frequency of non-attendance at clinic
Time frame: Baseline
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 24108523Kruis AL, Smidt N, Assendelft WJ, Gussekloo J, Boland MR, Rutten-van Molken M, Chavannes NH. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2013 Oct 10;(10):CD009437. doi: 10.1002/14651858.CD009437.pub2.
- Background: PubMed 25141877Wilkinson T, North M, Bourne SC. Reducing hospital admissions and improving the diagnosis of COPD in Southampton City: methods and results of a 12-month service improvement project. NPJ Prim Care Respir Med. 2014 Aug 21;24(0):14035. doi: 10.1038/npjpcrm.2014.35.
- Department of Health, 2011. An outcomes strategy for people with chronic obstructive pulmonary disease (COPD) and asthma in EnglandLink provided by the sponsor.
- Public Health England, 2014. Portsmouth Unitary Authority Health Profile 2014Link provided by the sponsor.
- Public Health England, 2015. Local Tobacco Control Proflies.Link 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 Pulmonary Disease, Chronic Obstructive, 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 6 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 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?
COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days (time frame: 6 months previous). The study lists 4 primary outcomes in all. 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 NCT02534766, 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 27 Sep 2016.