Chronic Obstructive Pulmonary Disease (COPD)NCT02728674
Management of Patients With Respiratory Symptoms in Sweden
A study testing Person in the case is a male., Person in the case is a female. and Symptom in the case is breathlessness. in people with Chronic Obstructive Pulmonary Disease (COPD), run by Skane University Hospital at 1 site in Sweden.
Trial summary
This is a web-based randomized survey to evaluate management of respiratory symptoms among physicians in Sweden. The aim of this study is to determine if there is a gender bias in the diagnosis of COPD and how often physicians identify that chronic refractory breathlessness requires treatment as compared to refractory… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Person in the case is a male., Person in the case is a female. and Symptom in the case is breathlessness.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2016to May 2017
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Certified physician
- Treats patients with respiratory symptoms and reduced physical activity
- Able to read and understand a hypothetical case in Swedish
Who cannot join
- Knowledge about the aim and/or design of the study, or
- Previous participation in the study
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Respiratory Medicine and Allergology
Lund, Skåne County, 21100
About this study
This is a web-based randomized survey to evaluate management of respiratory symptoms among physicians in Sweden. The aim of this study is to determine if there is a gender bias in the diagnosis of COPD and how often physicians identify that chronic refractory breathlessness requires treatment as compared to refractory pain.
Read the detailed description
BACKGROUND:
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. An American randomized web-based study showed important differences in the diagnosis of COPD among female and male patients.Women were more likely to be misdiagnosed as chronic cough or asthma instead of COPD and physicians were more reluctant to refer further women for spirometry.This is of importance as treatment and follow-up differ between the conditions.
Breathlessness, a subjective experience of breathing discomfort, is the cardinal symptom of cardiac and pulmonary disease. In advanced COPD, 98% of patients experience breathlessness which persists at rest or on minimal exertion, despite optimal treatment of the underlying disease (chronic refractory breathlessness). Dyspnea is linked to reduced physical activity, worsening deconditioning, increased anxiety and depression, impaired quality of life, loss of the will to live near death, increased risk of hospitalization, and earlier death.
The preferred treatment for the relief of chronic refractory breathlessness is a systemic (oral or parenteral) low dose opioid (Level I evidence). In a recent meta-analysis of 16 studies (271 patients in total), low dose opioids reduced chronic refractory breathlessness in advanced COPD, without any reported serious adverse effects. Lower dose opioids were not associated with increased risk of admission to hospital or death in a large register-based Swedish study of 2,249 patients with oxygen-dependent COPD patients treated with lower dose opioids (≤ 30mg of oral morphine/day).
Despite the growing evidence that support the use of opioids, physicians are reluctant to prescribe low dose opioids for breathlessness in COPD. In a review of 2000 random dispensed opioid prescriptions among patients with advanced COPD, most of whom suffered from severe chronic breathlessness, the most common stated indication was pain (97%), with only 2% for breathlessness. In a survey, Dutch chest physicians were reluctant to prescribe opioids for refractory breathlessness in advanced COPD due to perceived resistance from the patient and fear of adverse effects, including respiratory depression. Qualitative studies from Canada has shown that physicians in pulmonary medicine and primary care, families and patients feel that low dose opioids can be helpful for the relief of breathlessness, but that treatment was delayed or avoided due to lack of guidelines, lack of related knowledge and experience about opioids, and fears related to the potential adverse effects and legal censure.
No randomized trial has compared how physicians assess and treat refractory breathlessness versus refractory pain, how often opioids are considered for treatment of breathlessness and what factors affect the choice of treatment in chronic breathlessness as compared to pain in advanced COPD. Furthermore, it remains unknown if there is a gender bias in the diagnosis of COPD among physicians treating COPD patients.
METHOD:
This is a randomized, triple-blind, parallel group-, web-based study based on a survey instrument which is answered by certified physicians who treat patients with respiratory problems in Sweden. The survey is based upon a hypothetical patient case which regards situations and considerations that are part of physicians' daily clinical management and treatment of COPD patients. Two randomizations take place regarding the hypothetical case 1) Sex 2) Symptom. The participant is shown a hypothetical patient case which is randomized (1:1:1:1) regarding sex and symptom to one of four potential case scenarios: man+breathlessness; man+pain; woman+breathlessness; or woman+pain.
AIM:
The aim of the study is to determine if there is a gender bias in the diagnosis of COPD; how often physicians identify that chronic refractory breathlessness requires treatment as compared to refractory pain, which symptomatic treatments are considered with focus on morphine; explore physicians perception regarding the grade of evidence for different treatments for the relief of chronic breathlessness; and examine which factors affect physicians decision to treat refractory breathlessness with opioids.
- Being tested
- Person in the case is a male., Person in the case is a female., Symptom in the case is breathlessness., Symptom in the case is pain.
- Keywords
- COPD, Breathlessness, Symptom, Opioids, Gender bias
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Sexism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person in the case is a male.Other
Person in the case is a male.
Person in the case is a female.Other
Person in the case is a female.
Symptom in the case is breathlessness.Other
Symptom in the case is breathlessness.
Symptom in the case is pain.Other
Symptom in the case is pain.
| Study group | Role | What they receive |
|---|---|---|
| Man+Breathlessness | Other | Person in the case is a male. Symptom in the case is breathlessness. Receives: Other: Person in the case is a male.; Other: Symptom in the case is breathlessness. |
| Man+Pain | Other | Person in the case is a male. Symptom in the case is pain. Receives: Other: Person in the case is a male.; Other: Symptom in the case is pain. |
| Woman+Breathlessness | Other | Person in the case is a female. Symptom in the case is breathlessness. Receives: Other: Person in the case is a female.; Other: Symptom in the case is breathlessness. |
| Woman+Pain | Other | Person in the case is a female.Symptom in the case is pain. Receives: Other: Person in the case is a female.; Other: Symptom in the case is pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD treatment in the Questionnaire
Would there be a difference between the hypothetical case with breathlessness compared to the otherwise identical case with pain instead of breathlessness regarding:
- Proportion of study participants that consider that the patient in the case is not optimally treated;
- Proportion of study participants that consider morphine as either primary or secondary treatment option
Measured: through study completion, up to 6 months
Secondary outcomes (2)
Gender bias in COPD diagnosis in the Questionnaire
Would there be a difference between the cases with a male respective female patient regarding:
- Proportion of study participants that consider COPD diagnosis;
- Proportion of study participants that consider spirometry for further diagnostics
Measured: through study completion, up to 6 months
Symptomatic treatment in the Questionnaire
Would there be a difference between the case with breathlessness compared with the case with pain regarding:
- Chosen treatment options;
- Reasons not to choose treatment with opioids Chosen treatment options Reasons not to choose treatment with opioids
Measured: through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Ekström, Skane University Hospital
- Investigators
- Magnus Ekström, MD, PhD, Principal investigator, Department of Medicine, Blekinge Hospital, SE-37185 Karlskrona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728674
- Sponsor's protocol ID
- CASE2016
- Status last verified
- Aug 2017
- First submitted
- 24 Mar 2016
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ahmadi Z, Sandberg J, Shannon-Honson A, Vandersman Z, Currow DC, Ekstrom M. Is chronic breathlessness less recognised and treated compared with chronic pain? A case-based randomised controlled trial. Eur Respir J. 2018 Sep 15;52(3):1800887. doi: 10.1183/13993003.00887-2018. Print 2018 Sep.
PubMed 30002106
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Patients With Respiratory Symptoms in Sweden
- ClinicalTrials.gov ID
- NCT02728674
- Acronym / sponsor ID
- CASE2016
- Keywords
- COPD, Breathlessness, Symptom, Opioids, Gender bias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 5 Apr 2016 (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 web-based randomized survey to evaluate management of respiratory symptoms among physicians in Sweden. The aim of this study is to determine if there is a gender bias in the diagnosis of COPD and how often physicians identify that chronic refractory breathlessness requires treatment as compared to refractory pain.
Detailed description
BACKGROUND:
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. An American randomized web-based study showed important differences in the diagnosis of COPD among female and male patients.Women were more likely to be misdiagnosed as chronic cough or asthma instead of COPD and physicians were more reluctant to refer further women for spirometry.This is of importance as treatment and follow-up differ between the conditions.
Breathlessness, a subjective experience of breathing discomfort, is the cardinal symptom of cardiac and pulmonary disease. In advanced COPD, 98% of patients experience breathlessness which persists at rest or on minimal exertion, despite optimal treatment of the underlying disease (chronic refractory breathlessness). Dyspnea is linked to reduced physical activity, worsening deconditioning, increased anxiety and depression, impaired quality of life, loss of the will to live near death, increased risk of hospitalization, and earlier death.
The preferred treatment for the relief of chronic refractory breathlessness is a systemic (oral or parenteral) low dose opioid (Level I evidence). In a recent meta-analysis of 16 studies (271 patients in total), low dose opioids reduced chronic refractory breathlessness in advanced COPD, without any reported serious adverse effects. Lower dose opioids were not associated with increased risk of admission to hospital or death in a large register-based Swedish study of 2,249 patients with oxygen-dependent COPD patients treated with lower dose opioids (≤ 30mg of oral morphine/day).
Despite the growing evidence that support the use of opioids, physicians are reluctant to prescribe low dose opioids for breathlessness in COPD. In a review of 2000 random dispensed opioid prescriptions among patients with advanced COPD, most of whom suffered from severe chronic breathlessness, the most common stated indication was pain (97%), with only 2% for breathlessness. In a survey, Dutch chest physicians were reluctant to prescribe opioids for refractory breathlessness in advanced COPD due to perceived resistance from the patient and fear of adverse effects, including respiratory depression. Qualitative studies from Canada has shown that physicians in pulmonary medicine and primary care, families and patients feel that low dose opioids can be helpful for the relief of breathlessness, but that treatment was delayed or avoided due to lack of guidelines, lack of related knowledge and experience about opioids, and fears related to the potential adverse effects and legal censure.
No randomized trial has compared how physicians assess and treat refractory breathlessness versus refractory pain, how often opioids are considered for treatment of breathlessness and what factors affect the choice of treatment in chronic breathlessness as compared to pain in advanced COPD. Furthermore, it remains unknown if there is a gender bias in the diagnosis of COPD among physicians treating COPD patients.
METHOD:
This is a randomized, triple-blind, parallel group-, web-based study based on a survey instrument which is answered by certified physicians who treat patients with respiratory problems in Sweden. The survey is based upon a hypothetical patient case which regards situations and considerations that are part of physicians' daily clinical management and treatment of COPD patients. Two randomizations take place regarding the hypothetical case 1) Sex 2) Symptom. The participant is shown a hypothetical patient case which is randomized (1:1:1:1) regarding sex and symptom to one of four potential case scenarios: man+breathlessness; man+pain; woman+breathlessness; or woman+pain.
AIM:
The aim of the study is to determine if there is a gender bias in the diagnosis of COPD; how often physicians identify that chronic refractory breathlessness requires treatment as compared to refractory pain, which symptomatic treatments are considered with focus on morphine; explore physicians perception regarding the grade of evidence for different treatments for the relief of chronic breathlessness; and examine which factors affect physicians decision to treat refractory breathlessness with opioids.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Man+Breathlessness | Other | Other: Person in the case is a male., Other: Symptom in the case is breathlessness.Person in the case is a male. Symptom in the case is breathlessness. |
| Man+Pain | Other | Other: Person in the case is a male., Other: Symptom in the case is pain.Person in the case is a male. Symptom in the case is pain. |
| Woman+Breathlessness | Other | Other: Person in the case is a female., Other: Symptom in the case is breathlessness.Person in the case is a female. Symptom in the case is breathlessness. |
| Woman+Pain | Other | Other: Person in the case is a female., Other: Symptom in the case is pain.Person in the case is a female.Symptom in the case is pain. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Certified physician
- Treats patients with respiratory symptoms and reduced physical activity
- Able to read and understand a hypothetical case in Swedish
Key exclusion criteria (2 listed)
- Knowledge about the aim and/or design of the study, or
- Previous participation in the study
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 |
|---|---|---|
| Person in the case is a male.Person in the case is a male. | Other | Man+Breathlessness, Man+Pain |
| Person in the case is a female.Person in the case is a female. | Other | Woman+Breathlessness, Woman+Pain |
| Symptom in the case is breathlessness.Symptom in the case is breathlessness. | Other | Man+Breathlessness, Woman+Breathlessness |
| Symptom in the case is pain.Symptom in the case is pain. | Other | Man+Pain, Woman+Pain |
Primary outcome
COPD treatment in the Questionnaire
Time frame: through study completion, up to 6 months
Would there be a difference between the hypothetical case with breathlessness compared to the otherwise identical case with pain instead of breathlessness regarding: 1. Proportion of study participants that consider that the patient in the case is not optimally treated; 2. Proportion of study participants that consider morphine as either primary or secondary treatment option
2 secondary outcomes
Gender bias in COPD diagnosis in the Questionnaire
Time frame: through study completion, up to 6 months
Symptomatic treatment in the Questionnaire
Time frame: through study completion, up to 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 24 Aug 2017.
- Derived from this study: PubMed 30002106Ahmadi Z, Sandberg J, Shannon-Honson A, Vandersman Z, Currow DC, Ekstrom M. Is chronic breathlessness less recognised and treated compared with chronic pain? A case-based randomised controlled trial. Eur Respir J. 2018 Sep 15;52(3):1800887. doi: 10.1183/13993003.00887-2018. Print 2018 Sep.
- Individual participant dataSharing planned: No
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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.
Magnus Ekström, MD, PhD principal investigator
Department of Medicine, Blekinge Hospital, SE-37185 Karlskrona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Person in the case is a male., Person in the case is a female. and Symptom in the case is breathlessness. in people with Chronic Obstructive Pulmonary Disease (COPD), run by Skane University Hospital at 1 site in Sweden.
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 3 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 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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 treatment in the Questionnaire (time frame: through study completion, up to 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 NCT02728674, which also lists 1 linked publication.
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 24 Aug 2017.