Peak Inspiratory Flow (PIF) in COPD

• Sponsor: Pulmonary Research Institute of Southeast Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT04606394
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 45
• Location: 1
• Arm: 1
• Actual Duration (Months): 12.4
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
COPD	Drug: Trelegy Ellipta 100/62.5/25Mcg Inh 30D; Drug: Ventolin 90Mcg/Actuation Inhalation Aerosol	Phase 4

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

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Open label comparative designOpen label comparative design
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Peak Inspiratory Flow (PIF) in COPD
• Actual Study Start Date: Dec 2, 2020
• Actual Primary Completion Date: Dec 15, 2021
• Actual Study Completion Date: Dec 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Open label treatment All subjects receive Trelegy and Ventolin for 2 weeks	Drug: Trelegy Ellipta 100/62.5/25Mcg Inh 30D; Administration of Trelegy in all patients; Drug: Ventolin 90Mcg/Actuation Inhalation Aerosol; 2 hours after the administration of Trelegy, administer Ventolin in all patients

Outcome Measures

Primary Outcome Measures

1. FEV1 Response (to Ventolin Post Trelegy) [2 weeks]

   Change in FEV1 Pre versus Post Ventolin administration after having been administered Trelegy

Secondary Outcome Measures

1. PIF (pre Trelegy) [2 weeks]

   PIF measured prior to the administration of Trelegy

2. Correlation of PIF to FEV1 Response [2 weeks]

   Correlation of PIF (pre Trelegy) to FEV1 Response (to Ventolin Post Trelegy)

3. Optimal PIF [2 weeks]

   PIF measured while using 4 different inhalation instructions (pre Trelegy) correlated to FEV1 Response (to Ventolin Post Trelegy)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pulmonary Research Institute of Southeast Michigan	Farmington Hills	Michigan	United States	48336

Sponsors and Collaborators

• Pulmonary Research Institute of Southeast Michigan
• GlaxoSmithKline

Investigators

• Principal Investigator: Gary T Ferguson, MD, Pulmonary Research Institute of Southeast Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pulmonary Research Institute of Southeast Michigan
• ClinicalTrials.gov Identifier: NCT04606394
• Other Study ID Numbers: 001
• First Posted: Oct 28, 2020
• Last Update Posted: Dec 17, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Pulmonary Research Institute of Southeast Michigan: DPI; PIF; FEV1
• Additional relevant MeSH terms: Respiratory Aspiration; Albuterol

Study Results

No Results Posted as of Dec 17, 2021