COPDPhase 4NCT04606394

Peak Inspiratory Flow and Dry Powder Inhaler Performance in COPD

A Phase 4 study testing Trelegy Ellipta 100/62.5/25Mcg Inh 30D and Ventolin 90Mcg/Actuation Inhalation Aerosol in people with COPD, run by Pulmonary Research Institute of Southeast Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to determine whether PIF is clinically important when using the Ellipta DPI device. In addition, the study will validate the best/most clinically appropriate way to perform a PIF maneuver, to determine the testing capabilities of the preferred PIF maneuver and to relate this PIF measurement… Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: COPD
What is being tested?: Trelegy Ellipta 100/62.5/25Mcg Inh 30D and Ventolin 90Mcg/Actuation Inhalation Aerosol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 2 Dec 2020to 15 Dec 2021
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

smoking history >10 pack years
pre-bronchodilator FEV1 <60% predicted
post-bronchodilator FEV1/FVC <70%
female participants are eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions applies:
not a woman of childbearing potential OR
agree to follow the contraceptive guidance during the treatment period and until the safety follow-up contact after the last dose of study treatment
stratification requiring at least 1/3 of patients having a PIF of < 60L/min (AM pre-dose based on using the level 2 InCheck Dial resistance setting with a sharp maximal effort starting after exhaling fully)

Who cannot join

any subject with unstable disease, including
COPD exacerbation in the last 6 weeks
upper respiratory tract in in the last 4 weeks
COPD or upper respiratory tract infection during run-in (subjects may be re-screened x 1 when stable after an acute event)
pulmonary disease other than COPD
any lung resection
unstable cardiac conditions (at the discretion of the investigator)
other unstable medical conditions (at the discretion of the investigator)

Trial locations and contacts

1 site in 1 country.

United States1 site

Pulmonary Research Institute of Southeast Michigan
Farmington Hills, Michigan, 48336

Other trials in United States

About this study

Official title: Peak Inspiratory Flow (PIF) and Dry Powder Inhaler (DPI) Performance in Chronic Obstructive Pulmonary Disease (COPD)

Read the detailed description

Study Design and Methods Rationale

The expected FEV1 response to a bronchodilator is uncertain as multiple factors influence this measure, including severity of disease, day to day variability, varying reversibility in COPD patients, the delivery of the drug to a patient and the effectiveness of the medication delivered. Thus, the measurement of an acute bronchodilator response after delivering a long acting bronchodilator may not identify whether a medication has been effectively delivered to a patient.
However, if a long acting bronchodilator has not been effectively delivered to the lung, then subsequent delivery of a short acting bronchodilator should produce a significant additional bronchodilator response. On the other hand, if a long acting bronchodilator has been effectively delivered to the lung, then subsequent delivery of a short acting bronchodilator should not produce any further significant bronchodilation.
Based on this rationale, comparison of the acute bronchodilator response to a short acting bronchodilator after receiving a long acting should identify whether drug delivery is ineffective in a selected patient population, irrespective of baseline FEV1 and of any partial response to the long acting bronchodilator. Comparison of the short acting bronchodilator measurement between patient groups with differing PIF thresholds should identify whether PIF has an impact of drug delivery of a long acting bronchodilator via a DPI.
Open label design comparing the acute bronchodilator response after delivery of a long acting bronchodilator via Ellipta DPI in patients with normal, suboptimal and minimal PIF.

Conditions: COPD
Being tested: Trelegy Ellipta 100/62.5/25Mcg Inh 30D, Ventolin 90Mcg/Actuation Inhalation Aerosol
Keywords: DPI, PIF, FEV1
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.

Trelegy Ellipta 100/62.5/25Mcg Inh 30DDrug
Also called DPI Delivery
Administration of Trelegy in all patients
Ventolin 90Mcg/Actuation Inhalation AerosolDrug
Also called pMDI Delivery
2 hours after the administration of Trelegy, administer Ventolin in all patients

Study groups in NCT04606394
Study group	Role	What they receive
Open label treatment	Other	All subjects receive Trelegy and Ventolin for 2 weeks Receives: Drug: Trelegy Ellipta 100/62.5/25Mcg Inh 30D; Drug: Ventolin 90Mcg/Actuation Inhalation Aerosol

What is being measured

The primary outcome is the main question the study is designed to answer.

DPI Responder Analysis in Patients With Suboptimal PIF (<60 L/Min)
Outcome = the number of subject test days (2 test days per subject) meeting responder criteria defined as:
DPI Responder - a positive (>50 ml) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Partial Responder a positive (>50 ml) peak FEV1 response 2 hours after Trelegy® Ellipta DPI with a positive (>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Failure - a negative (<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a positive (>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) Irreversible - a negative (<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy)
Measured: 2 weeks

Secondary outcomes (2)

DPI Responder Analysis in Patients With Reduced PIF (<45 L/Min)
Outcome = the number of subject test days (2 test days per subject) meeting responder criteria defined as:
DPI Responder - a positive (>50 ml) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Partial Responder a positive (>50 ml) peak FEV1 response 2 hours after Trelegy® Ellipta DPI with a positive (>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Failure - a negative (<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a positive (>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) Irreversible - a negative (<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy)
Measured: 2 weeks
PIF Measurement Techniques
PIF value (L/min) based on different PIF measurement techniques
Measured: Baseline on day of testing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 202015 Dec 2021

First posted28 Oct 2020
Study start2 Dec 2020
Primary completion15 Dec 2021
Study completion15 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)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: Not applicable
Intervention model: Single group
Model description: Open label comparative design
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04606394
Sponsor's protocol ID: 001
Status last verified: Dec 2020
First submitted: 19 Oct 2020
Last updated: 8 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Perugini V, Rhee CK, Moon JY, Pei Yee T, Ra SW, Pirina P, Yoo KH, Navarrete BA, Gouder C, Pacheco A, Navarro-Rolon A, Harlander M, Lapperre T, Loh SCH, Fole D, Naval E, Palacios PJR, Miravitlles M, Usmani O. Assessment of peak inspiratory flow in patients with chronic obstructive pulmonary disease: a multicentre, observational, prospective, real-life study. BMJ Open Respir Res. 2025 Sep 25;12(1):e002408. doi: 10.1136/bmjresp-2024-002408.
PubMed 40998461

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Peak Inspiratory Flow (PIF) and Dry Powder Inhaler (DPI) Performance in Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT04606394
Acronym / sponsor ID: 001
Conditions: COPD
Keywords: DPI, PIF, FEV1
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Pulmonary Research Institute of Southeast MichiganUniversity, hospital or other
Collaborators: GlaxoSmithKline
Study start: 2 Dec 2020 (actual)
Primary completion: 15 Dec 2021 (actual)
Study completion: 15 Dec 2021 (actual)
First posted: 28 Oct 2020 (actual)
Results: Posted 8 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Design and Methods Rationale

The expected FEV1 response to a bronchodilator is uncertain as multiple factors influence this measure, including severity of disease, day to day variability, varying reversibility in COPD patients, the delivery of the drug to a patient and the effectiveness of the medication delivered. Thus, the measurement of an acute bronchodilator response after delivering a long acting bronchodilator may not identify whether a medication has been effectively delivered to a patient.
However, if a long acting bronchodilator has not been effectively delivered to the lung, then subsequent delivery of a short acting bronchodilator should produce a significant additional bronchodilator response. On the other hand, if a long acting bronchodilator has been effectively delivered to the lung, then subsequent delivery of a short acting bronchodilator should not produce any further significant bronchodilation.
Based on this rationale, comparison of the acute bronchodilator response to a short acting bronchodilator after receiving a long acting should identify whether drug delivery is ineffective in a selected patient population, irrespective of baseline FEV1 and of any partial response to the long acting bronchodilator. Comparison of the short acting bronchodilator measurement between patient groups with differing PIF thresholds should identify whether PIF has an impact of drug delivery of a long acting bronchodilator via a DPI.
Open label design comparing the acute bronchodilator response after delivery of a long acting bronchodilator via Ellipta DPI in patients with normal, suboptimal and minimal PIF.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open label comparative design

Arm	Type	Receives
Open label treatment	Other	Drug: Trelegy Ellipta 100/62.5/25Mcg Inh 30D, Drug: Ventolin 90Mcg/Actuation Inhalation AerosolAll subjects receive Trelegy and Ventolin for 2 weeks

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

smoking history >10 pack years
pre-bronchodilator FEV1 <60% predicted
post-bronchodilator FEV1/FVC <70%
female participants are eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions applies:
not a woman of childbearing potential OR

Key exclusion criteria (8 listed)

any subject with unstable disease, including
COPD exacerbation in the last 6 weeks
upper respiratory tract in in the last 4 weeks
COPD or upper respiratory tract infection during run-in (subjects may be re-screened x 1 when stable after an acute event)
pulmonary disease other than COPD

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
Trelegy Ellipta 100/62.5/25Mcg Inh 30DAlso: DPI DeliveryAdministration of Trelegy in all patients	Drug	Open label treatment
Ventolin 90Mcg/Actuation Inhalation AerosolAlso: pMDI Delivery2 hours after the administration of Trelegy, administer Ventolin in all patients	Drug	Open label treatment

Primary outcome

DPI Responder Analysis in Patients With Suboptimal PIF (<60 L/Min)
Time frame: 2 weeks
Outcome = the number of subject test days (2 test days per subject) meeting responder criteria defined as: DPI Responder - a positive (>50 ml) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Partial Responder a positive (>50 ml) peak FEV1 response 2 hours after Trelegy® Ellipta DPI with a positive (>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Failure - a negative (<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a positive (>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) Irreversible - a negative (<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy)

2 secondary outcomes

DPI Responder Analysis in Patients With Reduced PIF (<45 L/Min)
Time frame: 2 weeks
PIF Measurement Techniques
Time frame: Baseline on day of testing

Results and safety

Results posted to the registry on 8 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trelegy Ellipta Open Label Treatment	45	30

Primary outcome: DPI Responder Analysis in Patients With Suboptimal PIF (<60 L/Min)

Time frame: 2 weeks. Number. Unit: Number of subject test days

Measure	Suboptimal PIF n = 12	Normal PIF n = 18
Value	2	1

Suboptimal PIF vs Normal PIF: Mean Difference (Final Values): 1, p = 0.33, Chi-squared

Population analysed: Number of subject test days (2 per subject) with DPI Failure based on baseline PIF \<60 L/min or \>60 L/min

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks - from consent to 1 week post completion of study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open Label Treatment	0 of 45 (0%)	0 of 45 (0%)	0 of 45

Limitations and caveats (from the sponsor): No primary information was available to derive power calculations to estimate the number of subjects needed to test the study hypothesis

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40998461Perugini V, Rhee CK, Moon JY, Pei Yee T, Ra SW, Pirina P, Yoo KH, Navarrete BA, Gouder C, Pacheco A, Navarro-Rolon A, Harlander M, Lapperre T, Loh SCH, Fole D, Naval E, Palacios PJR, Miravitlles M, Usmani O. Assessment of peak inspiratory flow in patients with chronic obstructive pulmonary disease: a multicentre, observational, prospective, real-life study. BMJ Open Respir Res. 2025 Sep 25;12(1):e002408. doi: 10.1136/bmjresp-2024-002408.
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.

Gary T Ferguson, MD principal investigator

Pulmonary Research Institute of Southeast Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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.

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?

Yes. Results are posted in the registry (first posted 8 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

DPI Responder Analysis in Patients With Suboptimal PIF (<60 L/Min) (time frame: 2 weeks). 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 NCT04606394, which also lists 1 linked publication.

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 8 May 2023.