Chronic Obstructive Pulmonary Disease (COPD)NCT07453719
Improving Medication Management in COPD
A study testing Pharmacist-led Medication Management Intervention in people with Chronic Obstructive Pulmonary Disease (COPD), run by Duke University.
Trial summary
A pilot trial to examine feasibility of a pharmacist-led intervention for patients with COPD (Chronic Obstructive Pulmonary Disease) and multimorbidity to improve medication safety and reduce dyspnea. Patients will receive inhaler teaching and medication optimization counseling. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Pharmacist-led Medication Management Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 45
- Diagnosis of COPD
- Medicare/Medicaid insured
- Using an inhaler
- Reports dyspnea or suboptimal medication adherence
Who cannot join
- Under age 18 (caregivers/clinicians)
- Under age 45 (patients)
- Opioid use disorder
- Cognitive impairment
- Unable to communicate in English
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility Pilot Trial of a Pharmacist-led Medication Management Intervention for Multi-Morbid Adults With Chronic Obstructive Pulmonary Disease
A pilot trial to examine feasibility of a pharmacist-led intervention for patients with COPD (Chronic Obstructive Pulmonary Disease) and multimorbidity to improve medication safety and reduce dyspnea. Patients will receive inhaler teaching and medication optimization counseling. Outcomes include feasibility, acceptability, appropriateness, and exploratory measures such as medication discontinuation and patient-reported symptom burden.
- Being tested
- Pharmacist-led Medication Management Intervention
- Keywords
- COPD, Medication Management, Deprescribing
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led Medication Management InterventionBehavioural
In-clinic or telehealth pharmacist visit for inhaler teaching, medication optimization, and deprescribing counseling; includes follow-up at weeks 4 and 12.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist-led Medication Management | Experimental | Pharmacist visit for inhaler teaching and medication optimization with follow-up at weeks 4 and 12. Receives: Behavioral: Pharmacist-led Medication Management Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible patients recruited to the intervention
A measure of feasibility of the intervention.
Measured: Through the end of enrollment period, up to approximately 1 year
Secondary outcomes (6)
Acceptability of Intervention Measure (AIM)
The AIM is comprised of 4 items rated on a 5-point Likert scale, where the total score ranges from 4 to 20. A higher score indicates greater acceptability.
Measured: Baseline, 4 weeks, 12 weeks
Feasibility of Intervention Measure (FIM)
The FIM is comprised of 4 items rated on a 5-point Likert scale, where the total score ranges from 4 to 20. A higher score indicates greater feasibility.
Measured: Baseline, 4 weeks, 12 weeks
Intervention Appropriateness Measure (IAM)
The IAM is comprised of 4 items rated on a 5-point Likert scale, where the total score ranges from 4 to 20. A higher score indicates greater appropriateness.
Measured: Baseline, 4 weeks, 12 weeks
Modified Medical Research Council (mMRC) questionnaire to measure dyspnea
The mMRC dyspnea scale is a 5-grade (0 to 4) questionnaire that measures the severity of breathlessness in daily activities, commonly used for assessing functional disability in COPD and other respiratory diseases. A higher score indicates greater, more incapacitating breathlessness.
Measured: Baseline, 4 weeks, 12 weeks
Medication side effect burden, measured via Living with Medicines Questionnaire (LMQ-3)
Medication side effect burden refers to the physical, emotional, and practical impact of adverse drug reactions, often causing reduced quality of life, non-adherence, and treatment discontinuation.
Measured: Baseline, 4 weeks, 12 weeks
Shared Decision Making (SDM-Q-9) questionnaires
The SDM-Q-9 has a total score range of 0 to 45, where a higher score indicates greater shared decision-making between patients and providers.
Measured: Baseline, 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Cara McDermott, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453719
- Sponsor's protocol ID
- Pro00118496
- Other IDs
- K23HL159239
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Pilot Trial of a Pharmacist-led Medication Management Intervention for Multi-Morbid Adults With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07453719
- Acronym / sponsor ID
- Pro00118496
- Keywords
- COPD, Medication Management, Deprescribing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 6 Mar 2026 (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.
A pilot trial to examine feasibility of a pharmacist-led intervention for patients with COPD (Chronic Obstructive Pulmonary Disease) and multimorbidity to improve medication safety and reduce dyspnea. Patients will receive inhaler teaching and medication optimization counseling. Outcomes include feasibility, acceptability, appropriateness, and exploratory measures such as medication discontinuation and patient-reported symptom burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacist-led Medication Management | Experimental | Behavioral: Pharmacist-led Medication Management InterventionPharmacist visit for inhaler teaching and medication optimization with follow-up at weeks 4 and 12. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 45
- Diagnosis of COPD
- Medicare/Medicaid insured
- Using an inhaler
- Reports dyspnea or suboptimal medication adherence
Key exclusion criteria (5 listed)
- Under age 18 (caregivers/clinicians)
- Under age 45 (patients)
- Opioid use disorder
- Cognitive impairment
- Unable to communicate in English
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 |
|---|---|---|
| Pharmacist-led Medication Management InterventionIn-clinic or telehealth pharmacist visit for inhaler teaching, medication optimization, and deprescribing counseling; includes follow-up at weeks 4 and 12. | Behavioural | Pharmacist-led Medication Management |
Primary outcome
Proportion of eligible patients recruited to the intervention
Time frame: Through the end of enrollment period, up to approximately 1 year
A measure of feasibility of the intervention.
6 secondary outcomes
Acceptability of Intervention Measure (AIM)
Time frame: Baseline, 4 weeks, 12 weeks
Feasibility of Intervention Measure (FIM)
Time frame: Baseline, 4 weeks, 12 weeks
Intervention Appropriateness Measure (IAM)
Time frame: Baseline, 4 weeks, 12 weeks
Modified Medical Research Council (mMRC) questionnaire to measure dyspnea
Time frame: Baseline, 4 weeks, 12 weeks
Medication side effect burden, measured via Living with Medicines Questionnaire (LMQ-3)
Time frame: Baseline, 4 weeks, 12 weeks
Shared Decision Making (SDM-Q-9) questionnaires
Time frame: Baseline, 4 weeks, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- 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.
Cara McDermott principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-led Medication Management Intervention in people with Chronic Obstructive Pulmonary Disease (COPD), run by Duke University.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Hecker, MSN, RN ((919) 660-6612, emily.hecker@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible patients recruited to the intervention (time frame: Through the end of enrollment period, up to approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2026.