Peak Inspiratory Flow and Dry Powder Inhaler Performance in COPD

NCT ID: NCT04606394

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-02
• Study Completion Date: 2021-12-15

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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open label treatment

All subjects receive Trelegy and Ventolin for 2 weeks

Group Type: OTHER

Trelegy Ellipta 100/62.5/25Mcg Inh 30D

Intervention Type: DRUG

Administration of Trelegy in all patients

Ventolin 90Mcg/Actuation Inhalation Aerosol

Intervention Type: DRUG

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

Interventions

Trelegy Ellipta 100/62.5/25Mcg Inh 30D

Administration of Trelegy in all patients

Intervention Type: DRUG

Ventolin 90Mcg/Actuation Inhalation Aerosol

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

Intervention Type: DRUG

Other Intervention Names

DPI Delivery; pMDI Delivery

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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)

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Pulmonary Research Institute of Southeast Michigan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary T Ferguson, MD

Role: PRINCIPAL_INVESTIGATOR

Pulmonary Research Institute of Southeast Michigan

Locations

Pulmonary Research Institute of Southeast Michigan

Farmington Hills, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40998461 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id