COPDINHALENCT06135324
Impairments That Affect Correct Inhaler Use in COPD
An observational study of COPD, run by COPD Foundation at 9 sites in United States.
Trial summary
INHALE is a one-year, multi-site observational research study funded by Viatris, with two aims: 1. Determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with chronic obstructive pulmonary disease (COPD). 2. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- How many people
- 500 participants
- Where
- 9 sitesUnited States
- Study dates
- 14 Dec 2023to 31 Oct 2025
- Phase
- Observational
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: As this is a novel proposal, there are no data to calculate a sample size. If 20% of patients exhibit cognitive impairment and 20% exhibit impairment in manual dexterity, 500 total patients provide a sample size of at least 100 patients to examine the relationships between these impairments and errors in correct inhaler use. To ensure an adequate number of patients with an impairment, the study team will receive weekly reports containing a summary of proportion of patients exhibiting either cognitive impairment or impairment in manual dexterity and may stop recruitment once at least 100 patients with an impairment and 100 patients with no impairment have been enrolled. A maximum of 500 patients will be enrolled.
Who may be able to join
- Age > 60 years
- > 10 pack-years smoking cigarettes
- Diagnosis of COPD based on GOLD Criteria
- Pulmonary function tests showing FEV1 < 60% predicted (pre-BD).
- Current use of one or more hand-held inhalers (pMDIs, SMIs, and/or DPIs).
Who cannot join
- Current diagnosis of dementia or known cognitive impairment -OR-
- Current diagnosis of impairment in manual dexterity including severe rheumatoid arthritis, severe arthritis/weakness of the hand/wrist, Parkinson's disease, and/or history of a previous cerebral vascular accident (CVA) resulting in significant musculoskeletal deficit (in judgement of PI).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Alabama at Birmingham - Lung Health Center
Birmingham, Alabama, 35233
Lahey Clinic, Inc.
Burlington, Massachusetts, 01805
Erlanger Health
Chattanooga, Tennessee, 37403
RUSH University
Chicago, Illinois, 60612
Valley Regional Hospital
Claremont, New Hampshire, 03743
University of Texas Medical Brach at Galveston
Galveston, Texas, 77555
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Midwest Chest Consultants, PC
Saint Charles, Missouri, 63301
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: Prevalence of Impairments in Cognitive Function and Manual Dexterity in Out-patients With COPD and Associations With Correct Inhaler Techniques (INHALE)
INHALE is a one-year, multi-site observational research study funded by Viatris, with two aims:
- Determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with chronic obstructive pulmonary disease (COPD).
- Assess the relationship of cognitive impairment and impaired manual dexterity with patient errors using current pMDIs, SMIs and/or DPIs.
Read the detailed description
To prescribe inhaled therapy for patients with COPD, health care professionals (HCPs) must make three decisions: short vs long-acting medication, medication class (beta2 agonists, muscarinic antagonists and/or corticosteroids) and delivery system.
At present, there is no guidance by national and international groups of experts on selecting the most appropriate delivery system for patients with COPD. On the other hand, there is a general belief among HCPs that there is no difference in efficacy among pressurized metered dose inhalers (pMDIs), slow mist inhalers (SMIs), dry powder inhalers (DPIs), and nebulizer delivery if the patient uses correct inhaler technique. Unfortunately, there is extensive evidence that patients with COPD exhibit numerous errors using hand-held devices. Experts have opined that HCPs should consider prescribing nebulizer medications for patients with COPD based on various factors or conditions, particularly cognitive impairment and problems with manual dexterity. However, there is little if any supportive evidence for these recommendations.
In stable out-patients with an established diagnosis of moderate to very severe COPD (pulmonary function tests within the last 12 months that demonstrate FEV1 < 60% Predicted required for screening purposes), we hypothesize the following:
- Cognitive impairment (mild to severe) is present in > 20% of this COPD population
- Impaired manual dexterity (minimally functional to nonfunctional) is present in > 20% of this COPD population
- Both cognitive impairment and impaired manual dexterity are associated with patient errors using their current hand-held inhalers.
The objectives of this study are:
- To determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with COPD
- To assess the relationships of cognitive impairment and impaired manual dexterity with patient errors using their current pMDIs, SMIs, and/or DPIs.
- Conditions
- COPD
- Keywords
- COPD, Inhaler
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Prevalence of Cognitive impairment and impaired manual dexterity | Determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with COPD | |
| Assess relationship of impairments with patient errors using pMDI, SMI, and/or DPIs | assess the relationships of cognitive impairment and impaired manual dexterity with patient errors using their prescribed, current pMDIs, SMIs, and/or DPIs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence
Determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with COPD.
Measured: Through study completion, average of 1 year by assessing cognitive levels using the Mini-Mental State Exam tool and Functional Dexterity Test for impaired manual dexterity function.
Errors using inhaler devices
Assess the relationships of cognitive impairment and impaired manual dexterity with patient errors using their current pMDIs, SMIs, and/or DPIs.
Measured: Through study completion, average of 1 year using a standardized check list for assessment of Inhaler Techniques using pMDI, SMI, and/or DPIs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start14 Dec 2023
- Primary completion30 Apr 2025
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- COPD Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Viatris Inc.
- Responsible party
- Sponsor
- Investigators
- Donald A Mahler, MD, Principal investigator, Valley Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135324
- Sponsor's protocol ID
- 2023-INHALE
- Acronym
- INHALE
- Status last verified
- May 2025
- First submitted
- 10 Nov 2023
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- 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 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Impairments in Cognitive Function and Manual Dexterity in Out-patients With COPD and Associations With Correct Inhaler Techniques (INHALE)
- ClinicalTrials.gov ID
- NCT06135324
- Acronym / sponsor ID
- INHALE / 2023-INHALE
- Conditions
- COPD
- Keywords
- COPD, Inhaler
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (actual)
- Lead sponsor
- COPD FoundationUniversity, hospital or other
- Collaborators
- Viatris Inc.
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 18 Nov 2023 (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.
INHALE is a one-year, multi-site observational research study funded by Viatris, with two aims:
- Determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with chronic obstructive pulmonary disease (COPD).
- Assess the relationship of cognitive impairment and impaired manual dexterity with patient errors using current pMDIs, SMIs and/or DPIs.
Detailed description
To prescribe inhaled therapy for patients with COPD, health care professionals (HCPs) must make three decisions: short vs long-acting medication, medication class (beta2 agonists, muscarinic antagonists and/or corticosteroids) and delivery system.
At present, there is no guidance by national and international groups of experts on selecting the most appropriate delivery system for patients with COPD. On the other hand, there is a general belief among HCPs that there is no difference in efficacy among pressurized metered dose inhalers (pMDIs), slow mist inhalers (SMIs), dry powder inhalers (DPIs), and nebulizer delivery if the patient uses correct inhaler technique. Unfortunately, there is extensive evidence that patients with COPD exhibit numerous errors using hand-held devices. Experts have opined that HCPs should consider prescribing nebulizer medications for patients with COPD based on various factors or conditions, particularly cognitive impairment and problems with manual dexterity. However, there is little if any supportive evidence for these recommendations.
In stable out-patients with an established diagnosis of moderate to very severe COPD (pulmonary function tests within the last 12 months that demonstrate FEV1 < 60% Predicted required for screening purposes), we hypothesize the following:
- Cognitive impairment (mild to severe) is present in > 20% of this COPD population
- Impaired manual dexterity (minimally functional to nonfunctional) is present in > 20% of this COPD population
- Both cognitive impairment and impaired manual dexterity are associated with patient errors using their current hand-held inhalers.
The objectives of this study are:
- To determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with COPD
- To assess the relationships of cognitive impairment and impaired manual dexterity with patient errors using their current pMDIs, SMIs, and/or DPIs.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevalence of Cognitive impairment and impaired manual dexterity | – | –Determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with COPD |
| Assess relationship of impairments with patient errors using pMDI, SMI, and/or DPIs | – | –assess the relationships of cognitive impairment and impaired manual dexterity with patient errors using their prescribed, current pMDIs, SMIs, and/or DPIs. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- As this is a novel proposal, there are no data to calculate a sample size. If 20% of patients exhibit cognitive impairment and 20% exhibit impairment in manual dexterity, 500 total patients provide a sample size of at least 100 patients to examine the relationships between these impairments and errors in correct inhaler use. To ensure an adequate number of patients with an impairment, the study team will receive weekly reports containing a summary of proportion of patients exhibiting either cognitive impairment or impairment in manual dexterity and may stop recruitment once at least 100 patients with an impairment and 100 patients with no impairment have been enrolled. A maximum of 500 patients will be enrolled.
Key inclusion criteria (5 listed)
- Age > 60 years
- > 10 pack-years smoking cigarettes
- Diagnosis of COPD based on GOLD Criteria
- Pulmonary function tests showing FEV1 < 60% predicted (pre-BD).
- Current use of one or more hand-held inhalers (pMDIs, SMIs, and/or DPIs).
Key exclusion criteria (2 listed)
- Current diagnosis of dementia or known cognitive impairment -OR-
- Current diagnosis of impairment in manual dexterity including severe rheumatoid arthritis, severe arthritis/weakness of the hand/wrist, Parkinson's disease, and/or history of a previous cerebral vascular accident (CVA) resulting in significant musculoskeletal deficit (in judgement of PI).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence
Time frame: Through study completion, average of 1 year by assessing cognitive levels using the Mini-Mental State Exam tool and Functional Dexterity Test for impaired manual dexterity function.
Determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with COPD.
Errors using inhaler devices
Time frame: Through study completion, average of 1 year using a standardized check list for assessment of Inhaler Techniques using pMDI, SMI, and/or DPIs.
Assess the relationships of cognitive impairment and impaired manual dexterity with patient errors using their current pMDIs, SMIs, and/or DPIs.
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 11 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald A Mahler, MD principal investigator
Valley Regional Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by COPD Foundation at 9 sites 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 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
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?
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?
Prevalence (time frame: Through study completion, average of 1 year by assessing cognitive levels using the Mini-Mental State Exam tool and Functional Dexterity Test for impaired manual dexterity function.). The study lists 2 primary outcomes in all. 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 11 May 2025.