COPDPhase 4MoreFoRCOPDNCT03834363
Morphine or Fentanyl for Refractory Dyspnea in COPD
A Phase 4 study testing Fentanyl and Morphine Retard in people with COPD, run by Huib A.M. Kerstjens at 10 sites in Netherlands.
Trial summary
Rationale: The most important complaint in severe COPD is dyspnea which is associated with a diminished exercise tolerance, reduced quality of life and can lead to anxiety and depression. If dyspnea continues to exist despite optimal therapy it is called refractory dyspnea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Fentanyl and Morphine Retard
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 10 sitesNetherlands
- Study dates
- 15 Nov 2019to 24 Aug 2024
- 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
- Age ≥ 40 years.
- Read, understood and signed the Informed Consent form.
- COPD GOLD class III or IV, according to GOLD criteria (Post-bronchodilation FEV/FVC <70% and FEV1 < 50%pred.
- Complaints of refractory dyspnea as established by patient and doctor.
- mMRC score ≥ 3.
- Life expectancy of ≥ 2 months.
- Optimized standard therapy according to Dutch LAN guideline for diagnosis and treatment of COPD.
Who cannot join
- Other severe disease with chronic pain or chronic dyspnea (a non substantial component of left sided heart failure is acceptable).
- Current use of opioids for whatever indication.
- Allergy / intolerance for opioids
- Psychiatric disease, not related to severe COPD.
- Exacerbation of COPD 8 weeks prior to inclusion or between screening and randomization.
- Problematic (leading to medical help or social problems) substance abuse during the last five years.
- Active malignancy, with the exception of planocellular or basal cell carcinoma of the skin.
- eGFR <15 ml/min
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Netherlands10 sites
Noordwest Ziekenhuisgroep Alkmaar
Alkmaar, North Holland, 1815 JD
Wilhelmina Ziekenhuis Assen
Assen, Drenthe, 9401 RK
Rode Kruis Ziekenhuis
Beverwijk, North Holland, 1942 LE
Medisch Spectrum Twente
Enschede, Overijssel, 7512 KZ
University Medical Center Groningen
Groningen, 9713GZ
Spaarne Gasthuis
Haarlem, North Holland, 2035 RC
Elkerliek Ziekenhuis
Helmond, North Brabant, 5707 HA
Ikazia Ziekenhuis
Rotterdam, South Holland, 3083 AN
Ommelander Ziekenhuis Groningen
Scheemda, Provincie Groningen, 9676 BJ
Isala Klinieken
Zwolle, Overijssel, 8025 AB
About this study
Rationale: The most important complaint in severe COPD is dyspnea which is associated with a diminished exercise tolerance, reduced quality of life and can lead to anxiety and depression. If dyspnea continues to exist despite optimal therapy it is called refractory dyspnea. There is evidence that morphine is effective and can safely be prescribed for treating refractory dyspnea.
However, a Dutch study recently showed that few pulmonologists actually prescribe opioids for this indication. The main reasons for this are concerns about side effects and respiratory insufficiency as well as negative emotions for the patient and families at the thought of using morphine.
Read more
Most studies investigating opioids for treatment of dyspnea are conducted with morphine tablets, and only a part of these patients suffered from COPD. To our knowledge there has not been a randomized controlled trial investigating fentanyl patches for refractory dyspnea in COPD patients. However, studies comparing fentanyl and morphine in pain management show that patients may prefer fentanyl patches and have less problems with obstipation.
Objective: There are three main objectives for this study.
First, the investigators will investigate the following hypothesis: Both fentanyl and morphine provide a reduction of dyspnea which is better than placebo. Fentanyl has less side effects than morphine.
Secondly, with this Dutch multi-center study the investigators would like to enlarge the evidence base and contribute to the experience with opioids for refractory dyspnea in COPD thereby greatly facilitating its implementation in the Netherlands.
Finally, the investigators will develop and evaluate educational material about opioid use for dyspnea in COPD.
Study design: This is a multi-center double blind, double-dummy cross-over randomized placebo-controlled trial with three study arms. A total of 60 COPD patients will be included in this study.
Participants will be treated sequentially with three combinations of medication and/or placebo medication in a random order. They will receive either a Fentanyl patch in combination with placebo tablets, a placebo patch with Morphine Slow release tablets or a placebo patch with placebo tablets. Main study parameters/endpoints: The primary endpoint is change in dyspnea sensation Secondary endpoints are change in HR-QoL, anxiety, sleep quality, hypercapnia and the number and seriousness of side effect.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Fentanyl Matrix
Fentanylpatch 12 mcg/hr, change patch every three days.
Morphine RetardDrug
Also called Morphine
Morphine retard capsules 10 mg bid.
Placebo patchDrug
Placebo patch, change patch every three days.
Placebo oral capsuleDrug
Placebo oral capsule bid
| Study group | Role | What they receive |
|---|---|---|
| Morphine capsules and Placebo patch | Active comparator | Morphine retard 10 mg twice daily Placebo patch, change every three days. Receives: Drug: Morphine Retard; Drug: Placebo patch |
| Placebo capsules and Fentanyl patch | Experimental | Placebo capsules twice daily Fentanyl patch 12 mcg/hr, change every three days Receives: Drug: Fentanyl; Drug: Placebo oral capsule |
| Placebo capsules and Placebo patch | Placebo comparator | Placebo capsules twice daily Placebo patch, change every three days Receives: Drug: Placebo patch; Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dyspnea sensation
Change in dyspnea sensation measured on a Numeric Rating Scale from 0 to 10. A lower score represents a better outcome.
Measured: Daily during the six week treatment period
Secondary outcomes (8)
Change in CCQ (HR-QoL)
Change in HR-QoL measured with the Clinical COPD Questionnaire. Scores range from 0 to 6. Lower values represent a better outcome.
Measured: Daily during the six week treatment period
Change in CRQ (HR-QoL)
Change in HR-QoL measured with Chronic Respiratory Disease Questionnare. Scores range from 1 to 7. A higher score represents a better outcome.
Measured: 4 times during the six week treatment period: baseline, 2 weeks, 4 weeks, 6 weeks.
Change in CRQ mastery (HR-QoL)
Change in HR-QoL measured with Chronic Respiratory Disease Questionnare, domain Mastery. Scores range from 1 to 7. A higher score represents a better outcome.
Measured: 4 times during the six week treatment period: baseline, 2 weeks, 4 weeks, 6 weeks.
Change on the HADS-A questionnaire (Anxiety)
Change on the Hospital Anxiety and Depression Scale-anxiety subscale. Scores range from 0 to 21. A lower score represents a better outcome.
Measured: 4 times during the six week treatment period: baseline, 2 weeks, 4 weeks, 6 weeks.
Side effects
Reported spontaneously in a daily patient diary and specifically, both open and named side effects at planned visits.
Measured: Daily during the six week treatment period
Hypercapnia
Change in pCO2 in capillary blood gas analysis
Measured: 4 times during the six week treatment period: baseline, 2 weeks, 4 weeks, 6 weeks.
Sleep quality
Change on a Numeric Rating Scale from 0 to 10. A lower score represents a better outcome.
Measured: Daily during the six week treatment period
Continued opioid use
Asked three months after the end of the treatment period
Measured: Once, three months after the end of the treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start15 Nov 2019
- Primary completion24 May 2024
- Study completion24 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover, double blind, double dummy Randomized Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huib A.M. Kerstjens
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Foundation for Asthma Prevention, Innovatiefonds Zorgverzekeraars
- Responsible party
- Sponsor-investigator, Huib A.M. Kerstjens, University Medical Center Groningen
- Investigators
- Huib AM Kerstjens, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834363
- Sponsor's protocol ID
- MoreFoRCOPD
- Acronym
- MoreFoRCOPD
- Status last verified
- May 2025
- First submitted
- 11 Jan 2019
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request
Publications
Blinderman CD, Homel P, Billings JA, Tennstedt S, Portenoy RK. Symptom distress and quality of life in patients with advanced chronic obstructive pulmonary disease. J Pain Symptom Manage. 2009 Jul;38(1):115-23. doi: 10.1016/j.jpainsymman.2008.07.006. Epub 2009 Feb 20.
PubMed 19232893Wiseman R, Rowett D, Allcroft P, Abernethy A, Currow DC. Chronic refractory dyspnoea--evidence based management. Aust Fam Physician. 2013 Mar;42(3):137-40.
PubMed 23529525Abernethy AP, Currow DC, Frith P, Fazekas BS, McHugh A, Bui C. Randomised, double blind, placebo controlled crossover trial of sustained release morphine for the management of refractory dyspnoea. BMJ. 2003 Sep 6;327(7414):523-8. doi: 10.1136/bmj.327.7414.523.
PubMed 12958109Jennings AL, Davies AN, Higgins JP, Gibbs JS, Broadley KE. A systematic review of the use of opioids in the management of dyspnoea. Thorax. 2002 Nov;57(11):939-44. doi: 10.1136/thorax.57.11.939.
PubMed 12403875Janssen DJ, de Hosson SM, bij de Vaate E, Mooren KJ, Baas AA. Attitudes toward opioids for refractory dyspnea in COPD among Dutch chest physicians. Chron Respir Dis. 2015 May;12(2):85-92. doi: 10.1177/1479972315571926. Epub 2015 Feb 12.
PubMed 25676931Simon ST, Koskeroglu P, Gaertner J, Voltz R. Fentanyl for the relief of refractory breathlessness: a systematic review. J Pain Symptom Manage. 2013 Dec;46(6):874-86. doi: 10.1016/j.jpainsymman.2013.02.019. Epub 2013 Jun 4.
PubMed 23742735Payne R, Mathias SD, Pasta DJ, Wanke LA, Williams R, Mahmoud R. Quality of life and cancer pain: satisfaction and side effects with transdermal fentanyl versus oral morphine. J Clin Oncol. 1998 Apr;16(4):1588-93. doi: 10.1200/JCO.1998.16.4.1588.
PubMed 9552070Allan L, Hays H, Jensen NH, de Waroux BL, Bolt M, Donald R, Kalso E. Randomised crossover trial of transdermal fentanyl and sustained release oral morphine for treating chronic non-cancer pain. BMJ. 2001 May 12;322(7295):1154-8. doi: 10.1136/bmj.322.7295.1154.
PubMed 11348910Johnson MJ, Bland JM, Oxberry SG, Abernethy AP, Currow DC. Clinically important differences in the intensity of chronic refractory breathlessness. J Pain Symptom Manage. 2013 Dec;46(6):957-63. doi: 10.1016/j.jpainsymman.2013.01.011. Epub 2013 Apr 19.
PubMed 23608121Currow DC, McDonald C, Oaten S, Kenny B, Allcroft P, Frith P, Briffa M, Johnson MJ, Abernethy AP. Once-daily opioids for chronic dyspnea: a dose increment and pharmacovigilance study. J Pain Symptom Manage. 2011 Sep;42(3):388-99. doi: 10.1016/j.jpainsymman.2010.11.021. Epub 2011 Mar 31.
PubMed 21458217Jensen D, Alsuhail A, Viola R, Dudgeon DJ, Webb KA, O'Donnell DE. Inhaled fentanyl citrate improves exercise endurance during high-intensity constant work rate cycle exercise in chronic obstructive pulmonary disease. J Pain Symptom Manage. 2012 Apr;43(4):706-19. doi: 10.1016/j.jpainsymman.2011.05.007. Epub 2011 Dec 14.
PubMed 22168961Hui D, Kilgore K, Frisbee-Hume S, Park M, Liu D, Balachandran DD, Bruera E. Effect of Prophylactic Fentanyl Buccal Tablet on Episodic Exertional Dyspnea: A Pilot Double-Blind Randomized Controlled Trial. J Pain Symptom Manage. 2017 Dec;54(6):798-805. doi: 10.1016/j.jpainsymman.2017.08.001. Epub 2017 Aug 10.
PubMed 28803087van Dijk M, Mooren KJM, van den Berg JK, van Beurden-Moeskops WJC, Heller-Baan R, de Hosson SM, Lam-Wong WY, Peters L, Pool K, Kerstjens HAM. Opioids in patients with COPD and refractory dyspnea: literature review and design of a multicenter double blind study of low dosed morphine and fentanyl (MoreFoRCOPD). BMC Pulm Med. 2021 Sep 10;21(1):289. doi: 10.1186/s12890-021-01647-8.
PubMed 34507574
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphine or Fentanyl for Refractory Dyspnea in COPD
- ClinicalTrials.gov ID
- NCT03834363
- Acronym / sponsor ID
- MoreFoRCOPD / MoreFoRCOPD
- Conditions
- COPD
- Keywords
- COPD, Refractory Dyspnea, Morphine, Fentanyl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Huib A.M. KerstjensUniversity, hospital or other
- Collaborators
- Dutch Foundation for Asthma Prevention, Innovatiefonds Zorgverzekeraars
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 Aug 2024 (actual)
- First posted
- 7 Feb 2019 (actual)
- 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.
Rationale: The most important complaint in severe COPD is dyspnea which is associated with a diminished exercise tolerance, reduced quality of life and can lead to anxiety and depression. If dyspnea continues to exist despite optimal therapy it is called refractory dyspnea. There is evidence that morphine is effective and can safely be prescribed for treating refractory dyspnea.
However, a Dutch study recently showed that few pulmonologists actually prescribe opioids for this indication. The main reasons for this are concerns about side effects and respiratory insufficiency as well as negative emotions for the patient and families at the thought of using morphine.
Most studies investigating opioids for treatment of dyspnea are conducted with morphine tablets, and only a part of these patients suffered from COPD. To our knowledge there has not been a randomized controlled trial investigating fentanyl patches for refractory dyspnea in COPD patients. However, studies comparing fentanyl and morphine in pain management show that patients may prefer fentanyl patches and have less problems with obstipation.
Objective: There are three main objectives for this study.
First, the investigators will investigate the following hypothesis: Both fentanyl and morphine provide a reduction of dyspnea which is better than placebo. Fentanyl has less side effects than morphine.
Secondly, with this Dutch multi-center study the investigators would like to enlarge the evidence base and contribute to the experience with opioids for refractory dyspnea in COPD thereby greatly facilitating its implementation in the Netherlands.
Finally, the investigators will develop and evaluate educational material about opioid use for dyspnea in COPD.
Study design: This is a multi-center double blind, double-dummy cross-over randomized placebo-controlled trial with three study arms. A total of 60 COPD patients will be included in this study.
Participants will be treated sequentially with three combinations of medication and/or placebo medication in a random order. They will receive either a Fentanyl patch in combination with placebo tablets, a placebo patch with Morphine Slow release tablets or a placebo patch with placebo tablets. Main study parameters/endpoints: The primary endpoint is change in dyspnea sensation Secondary endpoints are change in HR-QoL, anxiety, sleep quality, hypercapnia and the number and seriousness of side effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Crossover, double blind, double dummy Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Morphine capsules and Placebo patch | Active comparator | Drug: Morphine Retard, Drug: Placebo patchMorphine retard 10 mg twice daily Placebo patch, change every three days. |
| Placebo capsules and Fentanyl patch | Experimental | Drug: Fentanyl, Drug: Placebo oral capsulePlacebo capsules twice daily Fentanyl patch 12 mcg/hr, change every three days |
| Placebo capsules and Placebo patch | Placebo comparator | Drug: Placebo patch, Drug: Placebo oral capsulePlacebo capsules twice daily Placebo patch, change every three days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 40 years.
- Read, understood and signed the Informed Consent form.
- COPD GOLD class III or IV, according to GOLD criteria (Post-bronchodilation FEV/FVC <70% and FEV1 < 50%pred.
- Complaints of refractory dyspnea as established by patient and doctor.
- mMRC score ≥ 3.
Key exclusion criteria (8 listed)
- Other severe disease with chronic pain or chronic dyspnea (a non substantial component of left sided heart failure is acceptable).
- Current use of opioids for whatever indication.
- Allergy / intolerance for opioids
- Psychiatric disease, not related to severe COPD.
- Exacerbation of COPD 8 weeks prior to inclusion or between screening and randomization.
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 |
|---|---|---|
| FentanylAlso: Fentanyl MatrixFentanylpatch 12 mcg/hr, change patch every three days. | Drug | Placebo capsules and Fentanyl patch |
| Morphine RetardAlso: MorphineMorphine retard capsules 10 mg bid. | Drug | Morphine capsules and Placebo patch |
| Placebo patchPlacebo patch, change patch every three days. | Drug | Morphine capsules and Placebo patch, Placebo capsules and Placebo patch |
| Placebo oral capsulePlacebo oral capsule bid | Drug | Placebo capsules and Fentanyl patch, Placebo capsules and Placebo patch |
Primary outcome
Change in dyspnea sensation
Time frame: Daily during the six week treatment period
Change in dyspnea sensation measured on a Numeric Rating Scale from 0 to 10. A lower score represents a better outcome.
8 secondary outcomes
Change in CCQ (HR-QoL)
Time frame: Daily during the six week treatment period
Change in CRQ (HR-QoL)
Time frame: 4 times during the six week treatment period: baseline, 2 weeks, 4 weeks, 6 weeks.
Change in CRQ mastery (HR-QoL)
Time frame: 4 times during the six week treatment period: baseline, 2 weeks, 4 weeks, 6 weeks.
Change on the HADS-A questionnaire (Anxiety)
Time frame: 4 times during the six week treatment period: baseline, 2 weeks, 4 weeks, 6 weeks.
Side effects
Time frame: Daily during the six week treatment period
Hypercapnia
Time frame: 4 times during the six week treatment period: baseline, 2 weeks, 4 weeks, 6 weeks.
Sleep quality
Time frame: Daily during the six week treatment period
Continued opioid use
Time frame: Once, three months after the end of the treatment period
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 Jun 2025.
- Background: PubMed 19232893Blinderman CD, Homel P, Billings JA, Tennstedt S, Portenoy RK. Symptom distress and quality of life in patients with advanced chronic obstructive pulmonary disease. J Pain Symptom Manage. 2009 Jul;38(1):115-23. doi: 10.1016/j.jpainsymman.2008.07.006. Epub 2009 Feb 20.
- Background: PubMed 23529525Wiseman R, Rowett D, Allcroft P, Abernethy A, Currow DC. Chronic refractory dyspnoea--evidence based management. Aust Fam Physician. 2013 Mar;42(3):137-40.
- Background: PubMed 12958109Abernethy AP, Currow DC, Frith P, Fazekas BS, McHugh A, Bui C. Randomised, double blind, placebo controlled crossover trial of sustained release morphine for the management of refractory dyspnoea. BMJ. 2003 Sep 6;327(7414):523-8. doi: 10.1136/bmj.327.7414.523.
- Background: PubMed 12403875Jennings AL, Davies AN, Higgins JP, Gibbs JS, Broadley KE. A systematic review of the use of opioids in the management of dyspnoea. Thorax. 2002 Nov;57(11):939-44. doi: 10.1136/thorax.57.11.939.
- Background: PubMed 25676931Janssen DJ, de Hosson SM, bij de Vaate E, Mooren KJ, Baas AA. Attitudes toward opioids for refractory dyspnea in COPD among Dutch chest physicians. Chron Respir Dis. 2015 May;12(2):85-92. doi: 10.1177/1479972315571926. Epub 2015 Feb 12.
- Background: PubMed 23742735Simon ST, Koskeroglu P, Gaertner J, Voltz R. Fentanyl for the relief of refractory breathlessness: a systematic review. J Pain Symptom Manage. 2013 Dec;46(6):874-86. doi: 10.1016/j.jpainsymman.2013.02.019. Epub 2013 Jun 4.
- Background: PubMed 9552070Payne R, Mathias SD, Pasta DJ, Wanke LA, Williams R, Mahmoud R. Quality of life and cancer pain: satisfaction and side effects with transdermal fentanyl versus oral morphine. J Clin Oncol. 1998 Apr;16(4):1588-93. doi: 10.1200/JCO.1998.16.4.1588.
- Background: PubMed 11348910Allan L, Hays H, Jensen NH, de Waroux BL, Bolt M, Donald R, Kalso E. Randomised crossover trial of transdermal fentanyl and sustained release oral morphine for treating chronic non-cancer pain. BMJ. 2001 May 12;322(7295):1154-8. doi: 10.1136/bmj.322.7295.1154.
- Background: PubMed 23608121Johnson MJ, Bland JM, Oxberry SG, Abernethy AP, Currow DC. Clinically important differences in the intensity of chronic refractory breathlessness. J Pain Symptom Manage. 2013 Dec;46(6):957-63. doi: 10.1016/j.jpainsymman.2013.01.011. Epub 2013 Apr 19.
- Background: PubMed 21458217Currow DC, McDonald C, Oaten S, Kenny B, Allcroft P, Frith P, Briffa M, Johnson MJ, Abernethy AP. Once-daily opioids for chronic dyspnea: a dose increment and pharmacovigilance study. J Pain Symptom Manage. 2011 Sep;42(3):388-99. doi: 10.1016/j.jpainsymman.2010.11.021. Epub 2011 Mar 31.
- Background: PubMed 22168961Jensen D, Alsuhail A, Viola R, Dudgeon DJ, Webb KA, O'Donnell DE. Inhaled fentanyl citrate improves exercise endurance during high-intensity constant work rate cycle exercise in chronic obstructive pulmonary disease. J Pain Symptom Manage. 2012 Apr;43(4):706-19. doi: 10.1016/j.jpainsymman.2011.05.007. Epub 2011 Dec 14.
- Background: PubMed 28803087Hui D, Kilgore K, Frisbee-Hume S, Park M, Liu D, Balachandran DD, Bruera E. Effect of Prophylactic Fentanyl Buccal Tablet on Episodic Exertional Dyspnea: A Pilot Double-Blind Randomized Controlled Trial. J Pain Symptom Manage. 2017 Dec;54(6):798-805. doi: 10.1016/j.jpainsymman.2017.08.001. Epub 2017 Aug 10.
- Individual participant dataSharing planned: Yes. Upon request
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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.
Huib AM Kerstjens, MD PhD principal investigator
University Medical Center Groningen
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl and Morphine Retard in people with COPD, run by Huib A.M. Kerstjens at 10 sites 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 7 inclusion and 8 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 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Change in dyspnea sensation (time frame: Daily during the six week treatment period). 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 NCT03834363, which also lists 13 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 Jun 2025.