Interstitial Lung DiseaseNCT05095363
Palliative Care Planner (PCplanner)
A study testing PCplanner in people with Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, run by Duke University at 1 site in United States.
Trial summary
The purpose of this research study is to determine the feasibility, acceptability, and evidence for clinical impact of a mobile app-based program called Palliative Care Planner (PCplanner) in addressing needs and promoting advance care planning discussions among patients with idiopathic pulmonary fibrosis and their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis
- What is being tested?
- PCplanner
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2022to 31 Mar 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has diagnosis of idiopathic pulmonary fibrosis
- Patient has GAP (gender, age, physiology) index score ≥ 4
- Patient is established in interstitial lung disease clinic (i.e., has had at least 1 previous clinic visit)
Who cannot join
- Patient lacks fluency in English sufficient to complete study surveys
- Patient is already seeing palliative care or enrolled in hospice
- NEST score <10 at baseline T1
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: The Palliative Care Planner (PCplanner) for Outpatients Pilot Trial
The purpose of this research study is to determine the feasibility, acceptability, and evidence for clinical impact of a mobile app-based program called Palliative Care Planner (PCplanner) in addressing needs and promoting advance care planning discussions among patients with idiopathic pulmonary fibrosis and their clinicians.
Read the detailed description
Interstitial lung disease (ILD) affects roughly 6.3 to 76 per 100,000 people of predominantly older adult patients worldwide and is associated with high morbidity and mortality. Patients with such idiopathic pulmonary fibrosis suffer symptom burdens similar to patients with cancer and commonly experience long, costly hospitalizations that often include care in an intensive care unit (ICU). Despite the presence of numerous unmet needs, ILD patients uncommonly receive palliative care because of lack of symptom recognition, supports to provide advanced care planning (ACP) and symptom control, and processes to promote collaboration between primary teams and palliative care specialists to deliver the appropriate level of care. To address this important clinical gap, we propose adapting our existing needs-targeted PCplanner (Palliative Care planner) mobile app platform to the outpatient setting. PCplanner Outpatient will allow patients to report their needs, provide video content to stimulate knowledge of and discussion about more advanced care planning, and assist primary physicians in recognizing the optimal timing of specialist palliative care referral.
- Being tested
- PCplanner
- Keywords
- palliative care, advance care planning
- Medical subject headings
- Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCplannerBehavioural
A mobile app platform that will display participant survey results to clinicians to facilitate communication on specific needs as well as provide resources on advance care planning to participants.
| Study group | Role | What they receive |
|---|---|---|
| PCplanner mobile app platform | Experimental | Participants who are randomized to the intervention arm will complete surveys at 3 timepoints and will be given resources on advance care planning via PCplanner, the mobile app platform. They will receive a telephone call by the study team about a week after enrollment to answer any questions about the resources provided. If needs and questions are not resolved quickly after the clinic visit, then another layer of patient support with a telephone call by a palliative care specialist will be provided to the participant to help develop potential management plans. Receives: Behavioral: PCplanner |
| Usual Care | No intervention | Participants who are randomized to the usual care arm will complete surveys at 3 timepoints and receive usual care by pulmonary clinician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention
Number of participants who stated intervention was easy to use as measured by patient survey.
Measured: Up to 16 weeks
Acceptability of intervention
Number of participants who stated they were satisfied with the intervention as measured by patient survey.
Measured: Up to 16 weeks
Completion of intervention
Number of participants who completed all three surveys and intervention telephone visits.
Measured: Up to 16 weeks
Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale
Scale ranges from 0 to 130 with lower score indicates less unmet needs and higher score indicates more unmet needs on issues such as communication, symptoms, social support, and financial stress.
Measured: Baseline to week 8
Documentation of advance care planning in electronic health record
Includes all or any of the following: code status, healthcare power of attorney, advance directive
Measured: Up to 16 weeks
Secondary outcomes (13)
Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale
Scale ranges from 0 to 130 with lower score indicates less unmet needs and higher score indicates more unmet needs on issues such as communication, symptoms, social support, and financial stress.
Measured: Baseline to week 16
Change in Patient Health Questionnaire-9 (PHQ-9) score
Score ranges from 0 to 27 with lower score indicates no or mild depression and higher score indicates more severe depression.
Measured: Baseline to week 8
Change in Patient Health Questionnaire-9 (PHQ-9) score
Score ranges from 0 to 27 with lower score indicates no or mild depression and higher score indicates more severe depression.
Measured: Baseline to week 16
Change in General Anxiety Disorder-7 (GAD-7) score
Score ranges from 0 to 21 with lower score indicates no or mild anxiety and higher score indicates more severe generalized anxiety.
Measured: Baseline to week 8
Change in General Anxiety Disorder-7 (GAD-7) score
Score ranges from 0 to 21 with lower score indicates no or mild anxiety and higher score indicates more severe generalized anxiety.
Measured: Baseline to week 16
Change in Patient Health Questionnaire-10 (PHQ-10) score
Scores range from 0 to 20 with lower score indicates less bothersome symptoms and higher score indicates more bothersome symptoms.
Measured: Baseline to week 8
Change in Patient Health Questionnaire-10 (PHQ-10) score
Scores range from 0 to 20 with lower score indicates less bothersome symptoms and higher score indicates more bothersome symptoms.
Measured: Baseline to week 16
Change in EuroQol - 5 Dimension (EQ-5D) score
Scores generally range from 0 (poor quality of life) to 1 (best quality of life possible)
Measured: Baseline to week 8
Change in EuroQol - 5 Dimension (EQ-5D) score
Scores generally range from 0 (poor quality of life) to 1 (best quality of life possible)
Measured: Baseline to week 16
Change in Quality of Life Visual Analogue Scale (QOL VAS)
Scores range from 0 to 100 with lower score indicates worse imaginable quality of life and higher score indicates better imaginable quality of life.
Measured: Baseline to week 8
Change in Quality of Life Visual Analogue Scale (QOL VAS)
Scores range from 0 to 100 with lower score indicates worse imaginable quality of life and higher score indicates better imaginable quality of life.
Measured: Baseline to week 16
Change in Therapeutic Alliance score
Score ranges from 16 to 64 with lower score indicates lower perceived alliance between patient and their provider and higher score indicates better therapeutic alliance.
Measured: Baseline to week 8
Change in Therapeutic Alliance score
Score ranges from 16 to 64 with lower score indicates lower perceived alliance between patient and their provider and higher score indicates better therapeutic alliance.
Measured: Baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start16 Mar 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Palliative Care planner (PCplanner) is a mobile app platform that aims to facilitate communication on unmet needs and advance care planning between patients with idiopathic pulmonary fibrosis and their pulmonary clinicians. Participants will be randomized to intervention arm in a 2:1 intervention:control ratio.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Cox, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095363
- Sponsor's protocol ID
- Pro00108264
- Status last verified
- Jan 2023
- First submitted
- 15 Oct 2021
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olson A, Hartmann N, Patnaik P, Wallace L, Schlenker-Herceg R, Nasser M, Richeldi L, Hoffmann-Vold AM, Cottin V. Estimation of the Prevalence of Progressive Fibrosing Interstitial Lung Diseases: Systematic Literature Review and Data from a Physician Survey. Adv Ther. 2021 Feb;38(2):854-867. doi: 10.1007/s12325-020-01578-6. Epub 2020 Dec 14.
PubMed 33315170Moens K, Higginson IJ, Harding R; EURO IMPACT. Are there differences in the prevalence of palliative care-related problems in people living with advanced cancer and eight non-cancer conditions? A systematic review. J Pain Symptom Manage. 2014 Oct;48(4):660-77. doi: 10.1016/j.jpainsymman.2013.11.009. Epub 2014 May 5.
PubMed 24801658Gore JM, Brophy CJ, Greenstone MA. How well do we care for patients with end stage chronic obstructive pulmonary disease (COPD)? A comparison of palliative care and quality of life in COPD and lung cancer. Thorax. 2000 Dec;55(12):1000-6. doi: 10.1136/thorax.55.12.1000.
PubMed 11083884Au DH, Udris EM, Fihn SD, McDonell MB, Curtis JR. Differences in health care utilization at the end of life among patients with chronic obstructive pulmonary disease and patients with lung cancer. Arch Intern Med. 2006 Feb 13;166(3):326-31. doi: 10.1001/archinte.166.3.326.
PubMed 16476873Bausewein C, Booth S, Gysels M, Kuhnbach R, Haberland B, Higginson IJ. Understanding breathlessness: cross-sectional comparison of symptom burden and palliative care needs in chronic obstructive pulmonary disease and cancer. J Palliat Med. 2010 Sep;13(9):1109-18. doi: 10.1089/jpm.2010.0068.
PubMed 20836635Bajwah S, Higginson IJ, Ross JR, Wells AU, Birring SS, Patel A, Riley J. Specialist palliative care is more than drugs: a retrospective study of ILD patients. Lung. 2012 Apr;190(2):215-20. doi: 10.1007/s00408-011-9355-7. Epub 2012 Jan 5.
PubMed 22218887Rabow MW, Dibble SL, Pantilat SZ, McPhee SJ. The comprehensive care team: a controlled trial of outpatient palliative medicine consultation. Arch Intern Med. 2004 Jan 12;164(1):83-91. doi: 10.1001/archinte.164.1.83.
PubMed 14718327Higginson IJ, Bausewein C, Reilly CC, Gao W, Gysels M, Dzingina M, McCrone P, Booth S, Jolley CJ, Moxham J. An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: a randomised controlled trial. Lancet Respir Med. 2014 Dec;2(12):979-87. doi: 10.1016/S2213-2600(14)70226-7. Epub 2014 Oct 29.
PubMed 25465642Ley B, Ryerson CJ, Vittinghoff E, Ryu JH, Tomassetti S, Lee JS, Poletti V, Buccioli M, Elicker BM, Jones KD, King TE Jr, Collard HR. A multidimensional index and staging system for idiopathic pulmonary fibrosis. Ann Intern Med. 2012 May 15;156(10):684-91. doi: 10.7326/0003-4819-156-10-201205150-00004.
PubMed 22586007Ryerson CJ, Vittinghoff E, Ley B, Lee JS, Mooney JJ, Jones KD, Elicker BM, Wolters PJ, Koth LL, King TE Jr, Collard HR. Predicting survival across chronic interstitial lung disease: the ILD-GAP model. Chest. 2014 Apr;145(4):723-728. doi: 10.1378/chest.13-1474.
PubMed 24114524Gu J, Wang P, Chow SC, Dempsey K, Bermejo S, Swaminathan A, Soskis A, Fried J, Kloefkorn C, Jones C, Cox CE. An App Platform-Facilitated Collaborative Palliative Care Intervention for Outpatients With Interstitial Lung Disease: A Pilot Randomized Trial. Am J Hosp Palliat Care. 2025 Jul;42(7):653-660. doi: 10.1177/10499091241275966. Epub 2024 Aug 19.
PubMed 39158903
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Palliative Care Planner (PCplanner) for Outpatients Pilot Trial
- ClinicalTrials.gov ID
- NCT05095363
- Acronym / sponsor ID
- Pro00108264
- Keywords
- palliative care, advance care planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 27 Oct 2021 (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.
The purpose of this research study is to determine the feasibility, acceptability, and evidence for clinical impact of a mobile app-based program called Palliative Care Planner (PCplanner) in addressing needs and promoting advance care planning discussions among patients with idiopathic pulmonary fibrosis and their clinicians.
Detailed description
Interstitial lung disease (ILD) affects roughly 6.3 to 76 per 100,000 people of predominantly older adult patients worldwide and is associated with high morbidity and mortality. Patients with such idiopathic pulmonary fibrosis suffer symptom burdens similar to patients with cancer and commonly experience long, costly hospitalizations that often include care in an intensive care unit (ICU). Despite the presence of numerous unmet needs, ILD patients uncommonly receive palliative care because of lack of symptom recognition, supports to provide advanced care planning (ACP) and symptom control, and processes to promote collaboration between primary teams and palliative care specialists to deliver the appropriate level of care. To address this important clinical gap, we propose adapting our existing needs-targeted PCplanner (Palliative Care planner) mobile app platform to the outpatient setting. PCplanner Outpatient will allow patients to report their needs, provide video content to stimulate knowledge of and discussion about more advanced care planning, and assist primary physicians in recognizing the optimal timing of specialist palliative care referral.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Palliative Care planner (PCplanner) is a mobile app platform that aims to facilitate communication on unmet needs and advance care planning between patients with idiopathic pulmonary fibrosis and their pulmonary clinicians. Participants will be randomized to intervention arm in a 2:1 intervention:control ratio.
| Arm | Type | Receives |
|---|---|---|
| PCplanner mobile app platform | Experimental | Behavioral: PCplannerParticipants who are randomized to the intervention arm will complete surveys at 3 timepoints and will be given resources on advance care planning via PCplanner, the mobile app platform. They will receive a telephone call by the study team about a week after enrollment to answer any questions about the resources provided. If needs and questions are not resolved quickly after the clinic visit, then another layer of patient support with a telephone call by a palliative care specialist will be provided to the participant to help develop potential management plans. |
| Usual Care | No intervention | –Participants who are randomized to the usual care arm will complete surveys at 3 timepoints and receive usual care by pulmonary clinician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has diagnosis of idiopathic pulmonary fibrosis
- Patient has GAP (gender, age, physiology) index score ≥ 4
- Patient is established in interstitial lung disease clinic (i.e., has had at least 1 previous clinic visit)
Key exclusion criteria (3 listed)
- Patient lacks fluency in English sufficient to complete study surveys
- Patient is already seeing palliative care or enrolled in hospice
- NEST score <10 at baseline T1
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 |
|---|---|---|
| PCplannerA mobile app platform that will display participant survey results to clinicians to facilitate communication on specific needs as well as provide resources on advance care planning to participants. | Behavioural | PCplanner mobile app platform |
Primary outcome
Feasibility of intervention
Time frame: Up to 16 weeks
Number of participants who stated intervention was easy to use as measured by patient survey.
Acceptability of intervention
Time frame: Up to 16 weeks
Number of participants who stated they were satisfied with the intervention as measured by patient survey.
Completion of intervention
Time frame: Up to 16 weeks
Number of participants who completed all three surveys and intervention telephone visits.
Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale
Time frame: Baseline to week 8
Scale ranges from 0 to 130 with lower score indicates less unmet needs and higher score indicates more unmet needs on issues such as communication, symptoms, social support, and financial stress.
Documentation of advance care planning in electronic health record
Time frame: Up to 16 weeks
Includes all or any of the following: code status, healthcare power of attorney, advance directive
13 secondary outcomes
Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale
Time frame: Baseline to week 16
Change in Patient Health Questionnaire-9 (PHQ-9) score
Time frame: Baseline to week 8
Change in Patient Health Questionnaire-9 (PHQ-9) score
Time frame: Baseline to week 16
Change in General Anxiety Disorder-7 (GAD-7) score
Time frame: Baseline to week 8
Change in General Anxiety Disorder-7 (GAD-7) score
Time frame: Baseline to week 16
Change in Patient Health Questionnaire-10 (PHQ-10) score
Time frame: Baseline to week 8
Change in Patient Health Questionnaire-10 (PHQ-10) score
Time frame: Baseline to week 16
Change in EuroQol - 5 Dimension (EQ-5D) score
Time frame: Baseline to week 8
Change in EuroQol - 5 Dimension (EQ-5D) score
Time frame: Baseline to week 16
Change in Quality of Life Visual Analogue Scale (QOL VAS)
Time frame: Baseline to week 8
Change in Quality of Life Visual Analogue Scale (QOL VAS)
Time frame: Baseline to week 16
Change in Therapeutic Alliance score
Time frame: Baseline to week 8
Change in Therapeutic Alliance score
Time frame: Baseline to week 16
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 12 May 2023.
- Background: PubMed 33315170Olson A, Hartmann N, Patnaik P, Wallace L, Schlenker-Herceg R, Nasser M, Richeldi L, Hoffmann-Vold AM, Cottin V. Estimation of the Prevalence of Progressive Fibrosing Interstitial Lung Diseases: Systematic Literature Review and Data from a Physician Survey. Adv Ther. 2021 Feb;38(2):854-867. doi: 10.1007/s12325-020-01578-6. Epub 2020 Dec 14.
- Background: PubMed 24801658Moens K, Higginson IJ, Harding R; EURO IMPACT. Are there differences in the prevalence of palliative care-related problems in people living with advanced cancer and eight non-cancer conditions? A systematic review. J Pain Symptom Manage. 2014 Oct;48(4):660-77. doi: 10.1016/j.jpainsymman.2013.11.009. Epub 2014 May 5.
- Background: PubMed 11083884Gore JM, Brophy CJ, Greenstone MA. How well do we care for patients with end stage chronic obstructive pulmonary disease (COPD)? A comparison of palliative care and quality of life in COPD and lung cancer. Thorax. 2000 Dec;55(12):1000-6. doi: 10.1136/thorax.55.12.1000.
- Background: PubMed 16476873Au DH, Udris EM, Fihn SD, McDonell MB, Curtis JR. Differences in health care utilization at the end of life among patients with chronic obstructive pulmonary disease and patients with lung cancer. Arch Intern Med. 2006 Feb 13;166(3):326-31. doi: 10.1001/archinte.166.3.326.
- Background: PubMed 20836635Bausewein C, Booth S, Gysels M, Kuhnbach R, Haberland B, Higginson IJ. Understanding breathlessness: cross-sectional comparison of symptom burden and palliative care needs in chronic obstructive pulmonary disease and cancer. J Palliat Med. 2010 Sep;13(9):1109-18. doi: 10.1089/jpm.2010.0068.
- Background: PubMed 22218887Bajwah S, Higginson IJ, Ross JR, Wells AU, Birring SS, Patel A, Riley J. Specialist palliative care is more than drugs: a retrospective study of ILD patients. Lung. 2012 Apr;190(2):215-20. doi: 10.1007/s00408-011-9355-7. Epub 2012 Jan 5.
- Background: PubMed 14718327Rabow MW, Dibble SL, Pantilat SZ, McPhee SJ. The comprehensive care team: a controlled trial of outpatient palliative medicine consultation. Arch Intern Med. 2004 Jan 12;164(1):83-91. doi: 10.1001/archinte.164.1.83.
- Background: PubMed 25465642Higginson IJ, Bausewein C, Reilly CC, Gao W, Gysels M, Dzingina M, McCrone P, Booth S, Jolley CJ, Moxham J. An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: a randomised controlled trial. Lancet Respir Med. 2014 Dec;2(12):979-87. doi: 10.1016/S2213-2600(14)70226-7. Epub 2014 Oct 29.
- Background: PubMed 22586007Ley B, Ryerson CJ, Vittinghoff E, Ryu JH, Tomassetti S, Lee JS, Poletti V, Buccioli M, Elicker BM, Jones KD, King TE Jr, Collard HR. A multidimensional index and staging system for idiopathic pulmonary fibrosis. Ann Intern Med. 2012 May 15;156(10):684-91. doi: 10.7326/0003-4819-156-10-201205150-00004.
- Background: PubMed 24114524Ryerson CJ, Vittinghoff E, Ley B, Lee JS, Mooney JJ, Jones KD, Elicker BM, Wolters PJ, Koth LL, King TE Jr, Collard HR. Predicting survival across chronic interstitial lung disease: the ILD-GAP model. Chest. 2014 Apr;145(4):723-728. doi: 10.1378/chest.13-1474.
- Derived from this study: PubMed 39158903Gu J, Wang P, Chow SC, Dempsey K, Bermejo S, Swaminathan A, Soskis A, Fried J, Kloefkorn C, Jones C, Cox CE. An App Platform-Facilitated Collaborative Palliative Care Intervention for Outpatients With Interstitial Lung Disease: A Pilot Randomized Trial. Am J Hosp Palliat Care. 2025 Jul;42(7):653-660. doi: 10.1177/10499091241275966. Epub 2024 Aug 19.
- Individual participant dataSharing planned: No
Related trials for Interstitial Lung Disease
RecruitingPhase 2
A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis
Recurrent Langerhans Cell Histiocytosis, Refractory Langerhans Cell Histiocytosis
Active, not recruitingObservational study
An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH
Pulmonary Hypertension, Interstitial Lung Disease
Not yet recruitingPhase 3
Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
Pulmonary Fibrosis
Active, not recruitingPhase 2
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
Idiopathic Pulmonary Fibrosis (IPF)
RecruitingPhase 2
A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
Idiopathic Pulmonary Fibrosis (IPF)
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.
Christopher Cox, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCplanner in people with Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, run by Duke University at 1 site in United States.
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 3 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 12 May 2023. 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 States. 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?
Feasibility of intervention (time frame: Up to 16 weeks). The study lists 5 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 NCT05095363, which also lists 11 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 12 May 2023.