Peak Inspiratory Flow and Dry Powder Inhaler Performance in COPD

NCT04606394 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 to meaningful clinical outcomes in COPD patients

Conditions

COPD

Keywords

DPI; PIF; FEV1

Outcome Measures

Primary Outcomes (1)

• 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)

  2 weeks

Secondary Outcomes (2)

• DPI Responder Analysis in Patients With Reduced PIF (<45 L/Min)

  2 weeks

• PIF Measurement Techniques

  Baseline on day of testing

Study Arms (1)

Open label treatment

OTHER

All subjects receive Trelegy and Ventolin for 2 weeks

Drug: Trelegy Ellipta 100/62.5/25Mcg Inh 30D; Drug: Ventolin 90Mcg/Actuation Inhalation Aerosol

Interventions

Trelegy Ellipta 100/62.5/25Mcg Inh 30D DRUG

Administration of Trelegy in all patients

Also known as: DPI Delivery

Open label treatment

Ventolin 90Mcg/Actuation Inhalation Aerosol DRUG

2 hours after the administration of Trelegy, administer Ventolin in all patients

Also known as: pMDI Delivery

Open label treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pulmonary Research Institute of Southeast Michigan: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Pulmonary Research Institute of Southeast Michigan

Farmington Hills, Michigan, 48336, United States

Location

Related Publications (1)

• 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.

  PMID: 40998461 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Limitations and Caveats

No primary information was available to derive power calculations to estimate the number of subjects needed to test the study hypothesis

Results Point of Contact

• Title: Gary T Ferguson, M.D.
• Organization: PRISM

garytferguson@msn.com

248-514-6063

Study Officials

• Gary T Ferguson, MD

  Pulmonary Research Institute of Southeast Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label comparative design

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 28, 2020
• Study Start: December 2, 2020
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: May 8, 2023
• Results First Posted: May 8, 2023

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)