Pulmonary Disease, Chronic ObstructivePhase 4MORDYCNCT02429050
Morphine for Treatment of Dyspnea in Patients With COPD
A Phase 4 study testing sustained release morphine in people with Pulmonary Disease, Chronic Obstructive, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Dyspnea is the most reported symptom of patients with advanced Chronic Obstructive Pulmonary Disease (COPD) and is undertreated. Morphine is an effective treatment for dyspnea and is recommended in clinical practice guidelines, but questions concerning benefits and concerns about respiratory adverse effects remain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- sustained release morphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Nov 2016to 1 Jul 2019
- Phase
- Phase 4
- 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
Who may be able to join
- Diagnosis of COPD according to the current Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (GOLD);
- Optimal pharmacological treatment, including including treatment with a combination of a long-acting muscarinic antagonist and an ultra-long-acting β-agonist;
- Grade 3 or 4 dyspnea on the mMRC dyspnea scale;
- Optimal non-pharmacological treatment defined as completed a comprehensive pulmonary rehabilitation program.
Who cannot join
- History of substance misuse;
- Exacerbation of COPD within two weeks of study enrolment;
- Waiting list for lung transplantation;
- Pregnant or childbearing potential not using contraception;
- Renal failure (creatinine clearance <15mL/min);
- Not being able to read or fill in the questionnaires or diary;
Show all 14Show fewer
- Allergy for morphine or its excipients;
- Concomitant use of irreversible MAO blockers;
- Use of opioids;
- History of convulsions;
- Head injury;
- Intestinal obstruction;
- Gastroparesis;
- Liver disease.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Ciro centre of expertise for chronic organ failure
Horn, 6080 AA
About this study
Official title: Morphine for Palliative Treatment of Refractory Dyspnea in Patients With Advanced COPD: Benefits and Respiratory Adverse Effects
Dyspnea is the most reported symptom of patients with advanced Chronic Obstructive Pulmonary Disease (COPD) and is undertreated. Morphine is an effective treatment for dyspnea and is recommended in clinical practice guidelines, but questions concerning benefits and concerns about respiratory adverse effects remain. For example, the effect on health-related quality of life and functional capacity is unknown. In one-third of the patients oral sustained release morphine (morphine SR) doesn't relieve dyspnea and it remains unknown whether severity and descriptors of breathlessness may predict a response to morphine. Finally, cost-effectiveness of morphine SR in this patient group is unknown. Therefore, prescription of morphine to patients with COPD is limited.
Objectives of this double blind randomized controlled trial are to study the effect of oral administration of morphine SR on health-related quality of life, respiratory adverse effects, and functional capacity; to explore whether description and severity of breathlessness are related with a clinically relevant response to morphine and to analyse the cost-effectiveness of morphine SR. The study population will consist of 124 clinically stable outpatients with COPD and severe dyspnea despite optimal pharmacological and non-pharmacological treatment.
Read the detailed description
Participants will be outpatients with a confirmed diagnosis of COPD, who suffer from severe dyspnea despite optimal pharmacological and non-pharmacological treatment. Participants will be recruited at CIRO, a center for pulmonary rehabilitation in the Netherlands after they completed a pulmonary rehabilitation program. After providing informed consent, patients will be randomized. Members of the research team who perform measurements will be blinded for treatment allocation.
Patients in the intervention group will receive regular clinical care and morphine SR 10mg, administered twice daily (20mg/24h), which can be increased after one or two weeks to three times per day 10mg (30mg/24h) in non-responders. Patients will be defined as non-responders if the mean dyspnea numeric rating scale (NRS) score was not reduced by 1 point in comparison with baseline. The control group will receive regular clinical care and placebo medication. Patients will receive morphine or placebo for four weeks. In addition, both groups will receive a prescription for a laxative and metoclopramide at the start of the intervention and will be instructed to adjust the dose as needed.
When the intervention period has ended, participants can choose to continue morphine treatment. They will be followed for twelve weeks to assess their healthcare use, use of morphine and number of adverse effects and exacerbations.
Measurements at baseline will include: demographics, medical history, medication, co-morbidities, exercise capacity, respiratory parameters, generic and disease-specific health-related quality of life (HRQoL), severity of dyspnea, sensory and affective dimensions of dyspnea, impact of dyspnea, cognition, level of daytime sleepiness, and functional capacity. A member of the research team will visit patients after 1 and 2 weeks in their home environment to assess adverse effects, compliance, exacerbations, disease-specific HRQoL, mobility, severity of dyspnea, and some respiratory parameters. A member of the research team will call the patient after 2 days and 3 weeks to assess adverse effects, compliance, exacerbations, and severity of dyspnea. After 4 weeks the following measurements will be performed: respiratory parameters, exercise capacity, general and disease-specific HRQoL, sensory and affective dimensions of dyspnea, impact of dyspnea, functional capacity, and adverse effects. Overnight oximetry will be performed in the home environment at baseline and after four weeks. A diary for costs and healthcare use will be filled in during four weeks.
Measurements during the twelve weeks following the intervention include: retrospective cost questionnaire, generic and disease-specific quality of life severity of dyspnea and adverse effects.
Statistical analyses Baseline characteristics will be compared between the intervention and control group using descriptive statistics. Chi square tests will be used for categorical variables. Independent sample T-tests and Mann-Whitney U-tests will be used for continuous variables, according to the variable distribution. Change in CAT-score, respiratory parameters and 6MWD between baseline and four weeks will be compared between patients in the intervention and the control group. First, mean change in CAT-score, respiratory parameters and 6MWD will be compared between the two groups using an independent sample T-test or Mann-Whitney U test, according to the variable distribution. Afterwards, multivariate analyses for longitudinal data will be performed. Analyses will be done using an intention-to-treat approach. The relationship between response to opioids and severity of dyspnea and descriptors of breathlessness will be explored using univariate analysis, followed by a binary logistic regression model. A trial-based economic evaluation will be performed, based on empirical data obtained in the RCT. The economic evaluation will be performed from the societal and healthcare perspective, the first including costs inside and outside the health care sector, and will follow published international guidelines. The time horizon of the trial-based economic evaluation will be four weeks. The outcomes of the twelve weeks following the intervention will be used in the model-based economic evaluation. The model will probably take the form of a Markov model; however this will be decided upon during the study.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- sustained release morphine, placebo
- Keywords
- Chronic Obstructive Pulmonary Disease, Dyspnea, Breathlessness, Morphine, Opioid, Symptom Management
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sustained release morphineDrug
Patients will receive morphine SR 10mg two to three times daily or placebo. Hard gelatin capsules of size AA in Swedish orange containing one morphine SR tablet 10 mg per capsule will be produced. Morphine SR has a marketing authorisation for pain and will be used according to current Dutch and international guidelines for treatment of dyspnea.
placeboDrug
Patients in the control group will receive placebo, consisting of microcrystalline cellulose (FMC BioPolymer). Hard gelatin capsules of size AA in Swedish orange containing microcrystalline cellulose will be produced.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Active comparator | sustained release morphine Receives: Drug: sustained release morphine |
| control | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-specific health-related quality of life (COPD Assessment Test (CAT))
Change in disease-specific health-related quality of life in four weeks measured with CAT
Measured: sixteen weeks
Change in partial pressure of CO2 (pCO2)
Change in pCO2 in four weeks
Measured: four weeks
Change in partial pressure of O2 (pO2)
Change in pO2 in four weeks
Measured: four weeks
Respiratory rate
Change in respiratory rate in four weeks
Measured: four weeks
Pulse oximetric saturation (SpO2)
Change in SpO2 in four weeks
Measured: four weeks
Transcutaneous carbon dioxide (PtcCO2)
Change in PtcCO2 in four weeks
Measured: four weeks
Oxygen saturation during the night
Change in oxygen saturation during the night in four weeks using overnight oximetry
Measured: four weeks
Secondary outcomes (12)
distance walked in 6 Minute Walking Test (6-MWT)
Change in exercise capacity in four weeks measured with 6-MWT
Measured: four weeks
Care dependency (Care Dependency Scale (CDS)
Change in care dependency in four weeks measured with CDS
Measured: four weeks
Mobility (Timed 'Up & Go' (TUG) test)
Change in mobility in four weeks measured with TUG test.
Measured: four weeks
Sensory and affective dimensions of dyspnea (Multidimensional Dyspnea Profile (MDP)
Sensory and affective dimensions of dyspnea in four weeks measured with MDP
Measured: four weeks
Impact of dyspnea (Pulmonary Functional Status and Dyspnea Questionnaire, PFSDQ-M)
Change in impact of dyspnea in four weeks measured with PFSDQ-M
Measured: four weeks
Severity of dyspnea (Numeric Rating Scale (NRS)
Change in severity of dyspnea in four weeks measured with NRS
Measured: sixteen weeks
Daytime sleepiness (Epworth Sleep Questionnaire)
Change in level of daytime sleepiness in four weeks measured with Epworth Sleep Questionnaire
Measured: four weeks
Cognition (Montreal Cognitive Assessment, (MoCA)
Change in cognition in four weeks measured with MoCA
Measured: four weeks
Number of patients with adverse effects
Adverse effects, including nausea, vomiting, constipation, drowsiness
Measured: sixteen weeks
Intake of medication
Number of missed medication intakes in four weeks
Measured: four weeks
Number of exacerbations
Number of exacerbations in four weeks
Measured: sixteen weeks
Cost of healthcare use in euro's
Cost of healthcare use in euro's based on the number of hospitalizations, number and type of contact with physician, use of (professional) homecare, use of medication and absence of (voluntary) work due to illness
Measured: sixteen weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study start16 Nov 2016
- Primary completion6 Mar 2019
- Study completion1 Jul 2019
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.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Daisy JA Janssen, MD, PhD, Principal investigator, Maastricht UMCE. FM Wouters, MD, PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429050
- Sponsor's protocol ID
- 152002
- Other IDs
- 80-83600-98-3006
- Acronym
- MORDYC
- Status last verified
- Mar 2019
- First submitted
- 2 Apr 2015
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Verberkt CA, van den Beuken-van Everdingen MHJ, Dirksen CD, Schols JMGA, Wouters EFM, Janssen DJA. Cost-effectiveness of sustained-release morphine for refractory breathlessness in COPD: A randomized clinical trial. Respir Med. 2021 Apr;179:106330. doi: 10.1016/j.rmed.2021.106330. Epub 2021 Feb 10.
PubMed 33611087Verberkt CA, van den Beuken-van Everdingen MHJ, Schols JMGA, Hameleers N, Wouters EFM, Janssen DJA. Effect of Sustained-Release Morphine for Refractory Breathlessness in Chronic Obstructive Pulmonary Disease on Health Status: A Randomized Clinical Trial. JAMA Intern Med. 2020 Oct 1;180(10):1306-1314. doi: 10.1001/jamainternmed.2020.3134.
PubMed 32804188
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphine for Palliative Treatment of Refractory Dyspnea in Patients With Advanced COPD: Benefits and Respiratory Adverse Effects
- ClinicalTrials.gov ID
- NCT02429050
- Acronym / sponsor ID
- MORDYC / 152002
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive Pulmonary Disease, Dyspnea, Breathlessness, Morphine, Opioid, Symptom Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 16 Nov 2016 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 29 Apr 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.
Dyspnea is the most reported symptom of patients with advanced Chronic Obstructive Pulmonary Disease (COPD) and is undertreated. Morphine is an effective treatment for dyspnea and is recommended in clinical practice guidelines, but questions concerning benefits and concerns about respiratory adverse effects remain. For example, the effect on health-related quality of life and functional capacity is unknown. In one-third of the patients oral sustained release morphine (morphine SR) doesn't relieve dyspnea and it remains unknown whether severity and descriptors of breathlessness may predict a response to morphine. Finally, cost-effectiveness of morphine SR in this patient group is unknown. Therefore, prescription of morphine to patients with COPD is limited.
Objectives of this double blind randomized controlled trial are to study the effect of oral administration of morphine SR on health-related quality of life, respiratory adverse effects, and functional capacity; to explore whether description and severity of breathlessness are related with a clinically relevant response to morphine and to analyse the cost-effectiveness of morphine SR. The study population will consist of 124 clinically stable outpatients with COPD and severe dyspnea despite optimal pharmacological and non-pharmacological treatment.
Detailed description
Participants will be outpatients with a confirmed diagnosis of COPD, who suffer from severe dyspnea despite optimal pharmacological and non-pharmacological treatment. Participants will be recruited at CIRO, a center for pulmonary rehabilitation in the Netherlands after they completed a pulmonary rehabilitation program. After providing informed consent, patients will be randomized. Members of the research team who perform measurements will be blinded for treatment allocation.
Patients in the intervention group will receive regular clinical care and morphine SR 10mg, administered twice daily (20mg/24h), which can be increased after one or two weeks to three times per day 10mg (30mg/24h) in non-responders. Patients will be defined as non-responders if the mean dyspnea numeric rating scale (NRS) score was not reduced by 1 point in comparison with baseline. The control group will receive regular clinical care and placebo medication. Patients will receive morphine or placebo for four weeks. In addition, both groups will receive a prescription for a laxative and metoclopramide at the start of the intervention and will be instructed to adjust the dose as needed.
When the intervention period has ended, participants can choose to continue morphine treatment. They will be followed for twelve weeks to assess their healthcare use, use of morphine and number of adverse effects and exacerbations.
Measurements at baseline will include: demographics, medical history, medication, co-morbidities, exercise capacity, respiratory parameters, generic and disease-specific health-related quality of life (HRQoL), severity of dyspnea, sensory and affective dimensions of dyspnea, impact of dyspnea, cognition, level of daytime sleepiness, and functional capacity. A member of the research team will visit patients after 1 and 2 weeks in their home environment to assess adverse effects, compliance, exacerbations, disease-specific HRQoL, mobility, severity of dyspnea, and some respiratory parameters. A member of the research team will call the patient after 2 days and 3 weeks to assess adverse effects, compliance, exacerbations, and severity of dyspnea. After 4 weeks the following measurements will be performed: respiratory parameters, exercise capacity, general and disease-specific HRQoL, sensory and affective dimensions of dyspnea, impact of dyspnea, functional capacity, and adverse effects. Overnight oximetry will be performed in the home environment at baseline and after four weeks. A diary for costs and healthcare use will be filled in during four weeks.
Measurements during the twelve weeks following the intervention include: retrospective cost questionnaire, generic and disease-specific quality of life severity of dyspnea and adverse effects.
Statistical analyses Baseline characteristics will be compared between the intervention and control group using descriptive statistics. Chi square tests will be used for categorical variables. Independent sample T-tests and Mann-Whitney U-tests will be used for continuous variables, according to the variable distribution. Change in CAT-score, respiratory parameters and 6MWD between baseline and four weeks will be compared between patients in the intervention and the control group. First, mean change in CAT-score, respiratory parameters and 6MWD will be compared between the two groups using an independent sample T-test or Mann-Whitney U test, according to the variable distribution. Afterwards, multivariate analyses for longitudinal data will be performed. Analyses will be done using an intention-to-treat approach. The relationship between response to opioids and severity of dyspnea and descriptors of breathlessness will be explored using univariate analysis, followed by a binary logistic regression model. A trial-based economic evaluation will be performed, based on empirical data obtained in the RCT. The economic evaluation will be performed from the societal and healthcare perspective, the first including costs inside and outside the health care sector, and will follow published international guidelines. The time horizon of the trial-based economic evaluation will be four weeks. The outcomes of the twelve weeks following the intervention will be used in the model-based economic evaluation. The model will probably take the form of a Markov model; however this will be decided upon during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Active comparator | Drug: sustained release morphinesustained release morphine |
| control | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of COPD according to the current Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (GOLD);
- Optimal pharmacological treatment, including including treatment with a combination of a long-acting muscarinic antagonist and an ultra-long-acting β-agonist;
- Grade 3 or 4 dyspnea on the mMRC dyspnea scale;
- Optimal non-pharmacological treatment defined as completed a comprehensive pulmonary rehabilitation program.
Key exclusion criteria (14 listed)
- History of substance misuse;
- Exacerbation of COPD within two weeks of study enrolment;
- Waiting list for lung transplantation;
- Pregnant or childbearing potential not using contraception;
- Renal failure (creatinine clearance <15mL/min);
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 |
|---|---|---|
| sustained release morphinePatients will receive morphine SR 10mg two to three times daily or placebo. Hard gelatin capsules of size AA in Swedish orange containing one morphine SR tablet 10 mg per capsule will be produced. Morphine SR has a marketing authorisation for pain and will be used according to current Dutch and international guidelines for treatment of dyspnea. | Drug | intervention |
| placeboPatients in the control group will receive placebo, consisting of microcrystalline cellulose (FMC BioPolymer). Hard gelatin capsules of size AA in Swedish orange containing microcrystalline cellulose will be produced. | Drug | control |
Primary outcome
Disease-specific health-related quality of life (COPD Assessment Test (CAT))
Time frame: sixteen weeks
Change in disease-specific health-related quality of life in four weeks measured with CAT
Change in partial pressure of CO2 (pCO2)
Time frame: four weeks
Change in pCO2 in four weeks
Change in partial pressure of O2 (pO2)
Time frame: four weeks
Change in pO2 in four weeks
Respiratory rate
Time frame: four weeks
Change in respiratory rate in four weeks
Pulse oximetric saturation (SpO2)
Time frame: four weeks
Change in SpO2 in four weeks
Transcutaneous carbon dioxide (PtcCO2)
Time frame: four weeks
Change in PtcCO2 in four weeks
Oxygen saturation during the night
Time frame: four weeks
Change in oxygen saturation during the night in four weeks using overnight oximetry
12 secondary outcomes
distance walked in 6 Minute Walking Test (6-MWT)
Time frame: four weeks
Care dependency (Care Dependency Scale (CDS)
Time frame: four weeks
Mobility (Timed 'Up & Go' (TUG) test)
Time frame: four weeks
Sensory and affective dimensions of dyspnea (Multidimensional Dyspnea Profile (MDP)
Time frame: four weeks
Impact of dyspnea (Pulmonary Functional Status and Dyspnea Questionnaire, PFSDQ-M)
Time frame: four weeks
Severity of dyspnea (Numeric Rating Scale (NRS)
Time frame: sixteen weeks
Daytime sleepiness (Epworth Sleep Questionnaire)
Time frame: four weeks
Cognition (Montreal Cognitive Assessment, (MoCA)
Time frame: four weeks
Number of patients with adverse effects
Time frame: sixteen weeks
Intake of medication
Time frame: four weeks
Number of exacerbations
Time frame: sixteen weeks
Cost of healthcare use in euro's
Time frame: sixteen weeks
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 4 Sep 2019.
- Derived from this study: PubMed 33611087Verberkt CA, van den Beuken-van Everdingen MHJ, Dirksen CD, Schols JMGA, Wouters EFM, Janssen DJA. Cost-effectiveness of sustained-release morphine for refractory breathlessness in COPD: A randomized clinical trial. Respir Med. 2021 Apr;179:106330. doi: 10.1016/j.rmed.2021.106330. Epub 2021 Feb 10.
- Derived from this study: PubMed 32804188Verberkt CA, van den Beuken-van Everdingen MHJ, Schols JMGA, Hameleers N, Wouters EFM, Janssen DJA. Effect of Sustained-Release Morphine for Refractory Breathlessness in Chronic Obstructive Pulmonary Disease on Health Status: A Randomized Clinical Trial. JAMA Intern Med. 2020 Oct 1;180(10):1306-1314. doi: 10.1001/jamainternmed.2020.3134.
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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.
Daisy JA Janssen, MD, PhD principal investigator
Maastricht UMC
E. FM Wouters, MD, PhD principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sustained release morphine in people with Pulmonary Disease, Chronic Obstructive, run by Maastricht University Medical Center at 1 site in Netherlands.
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 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. 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 Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Disease-specific health-related quality of life (COPD Assessment Test (CAT)) (time frame: sixteen weeks). The study lists 7 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 NCT02429050, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.