Peak Inspiratory Flow & Dry Powder Inhaler Performance in COPD

Status Completed

Clinical 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 to meaningful clinical outcomes in COPD patients

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04606394
Study type	Interventional
Source	Pulmonary Research Institute of Southeast Michigan
Contact
Status	Completed
Phase	Phase 4
Start date	December 2, 2020
Completion date	December 15, 2021

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06000696` - Healthy at Home Pilot
Active, not recruiting	`NCT03927820` - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)	N/A
Completed	`NCT04043728` - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study	N/A
Completed	`NCT04105075` - COPD in Obese Patients
Recruiting	`NCT05825261` - Exploring Novel Biomarkers for Emphysema Detection
Active, not recruiting	`NCT04075331` - Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial	Phase 2/Phase 3
Terminated	`NCT03640260` - Respiratory Regulation With Biofeedback in COPD	N/A
Recruiting	`NCT04872309` - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Recruiting	`NCT05145894` - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
Withdrawn	`NCT04210050` - Sleep Ventilation for Patients With Advanced Hypercapnic COPD	N/A
Terminated	`NCT03284203` - Feasibility of At-Home Handheld Spirometry	N/A
Recruiting	`NCT06110403` - Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness	Phase 1/Phase 2
Active, not recruiting	`NCT06040424` - Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients	Phase 3
Recruiting	`NCT05865184` - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Recruiting	`NCT04868357` - Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program	N/A
Completed	`NCT01892566` - Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV	N/A
Completed	`NCT04119856` - Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD	N/A
Completed	`NCT04485741` - Strados System at Center of Excellence
Completed	`NCT03626519` - Effects of Menthol on Dyspnoea in COPD Patients	N/A
Recruiting	`NCT04860375` - Multidisciplinary Management of Severe COPD	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Peak Inspiratory Flow and Dry Powder Inhaler Performance in COPD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms