COPD
Conditions
Keywords
peak inspiratory flow rate
Brief summary
Recent studies have reported that some Chronic Obstructive Pulmonary Disease (COPD) patients may have a suboptimal ability to generate a sufficient inspiratory effort to achieve adequate lung delivery of inhaled medications through dry powder inhalers. Sparse data is available about the inspiratory capacity of these patients in the home setting, whether clinically stable or when experiencing worsened respiratory symptoms outside the acute care setting. This study is undertaken to better understand the proportion of patients with suboptimal peak inspiratory flow rate (sPIFR) measurements amongst COPD patients receiving dry powder inhaler(s) (DPI) in the ambulatory setting. Further, the study will characterize PIFR over time, the variability of PIFR measurements, and the associations with potential predictors (demographics, clinical, Patient-Reported Outcomes (PRO), body position, and device) as well as exacerbations frequency and change in PIFR around period of exacerbation.
Detailed description
Recent studies have reported that some COPD patients may have a suboptimal ability to generate a sufficient inspiratory effort to achieve adequate lung delivery of inhaled medications through dry powder inhalers. Sparse data is available about the inspiratory capacity of these patients in the home setting, whether clinically stable or when experiencing worsened respiratory symptoms outside the acute care setting. This study is undertaking this study to better understand the proportion of patients with suboptimal peak inspiratory flow rate (sPIFR) measurements amongst COPD patients receiving dry powder inhaler(s) (DPI) in the ambulatory setting. Further, the study will characterize PIFR over time, the variability of PIFR measurements, and the associations with potential predictors (demographics, clinical, PRO, body position, and device) as well as exacerbations frequency and change in PIFR around period of exacerbation. To complete these aims, 120 participants will be enrolled in a 6 month study to perform PIFR measurements and respiratory questionnaires at home.
Interventions
DEVICEHome PIFR monitoring with InCheck Dial
The In-Check G16 DIAL® (Alliance Tech Medical, Granbury TX) is a simple hand-held device that measures PIFR via a brief inspiratory maneuver.
Sponsors
Boehringer Ingelheim
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 50 years-old * Spirometry-confirmed diagnosis of COPD (FEV1/FVC \<0.70) * Global initiative for Chronic Obstructive Lung Disease (GOLD) II-IV based on spirometry results * COPD Assessment Test (CAT) score \> 10 * For high resistance DPI, baseline PIFR \< 90 L/min (InCheck DIAL®) and \>=30 L/min; for medium resistance DPI, PIFR ≤ 90 L/min (InCheck DIAL®) and \>=60 L/min. Handihaler is a high resistance DPI. Examples of medium resistance DPI: Anoro, Incruse, Breo Ellipta®, Advair® Diskus® DP or Wixela® Inhub® * History of smoking tobacco products \> 10 pack years * Prescribed at least one daily maintenance DPI with no change in prescription within the four weeks prior to the Enrollment Visit * One or more exacerbations of COPD requiring systemic corticosteroids within last 2 years
Exclusion criteria
* Inability to demonstrate proper technique for the InCheck DIAL® device * Inability to achieve minimum PIFR for prescribed DPI(s) at screening/enrollment visit (\< 30 L/min for e.g., Handihaler® (High resistance DPI), \< 60 L/min for Ellipta® (Medium resistance DPI)) * Inability to perform spirometry to meet American Thoracic Society standards * Neuromuscular disease associated with weakness * Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study. * Pneumothorax within the past 4 weeks * For those participants who will require spirometry (i.e., if they have not had it within the past 3 months): Participants who present with a myocardial infarction or eye, chest or abdominal surgery within six weeks of baseline can be rescreened after the six week window has passed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Suboptimal PIFR | 24 weeks | The occurrence of suboptimal Peak Inspiratory Flow Rate (sPIFR) over 24 weeks. sPIFR will be defined as any two consecutive measurements on different days below the optimal threshold for any prescribed DPI (e.g.,\<30 L/min for Handihaler® (High resistance DPI), \<60 L/min for Ellipta® (Medium resistance DPI)) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Home PIFR Monitoring Measurement of PIFR using the InCheck Dial® device and quantification of respiratory symptoms and COPD exacerbations using standardized questionnaires in the patient's home setting and during research visits in the clinic setting
Home PIFR monitoring with InCheck Dial: The In-Check G16 DIAL® (Alliance Tech Medical, Granbury TX) is a simple hand-held device that measures PIFR via a brief inspiratory maneuver. | 80 |
| Total | 80 |
Baseline characteristics
| Characteristic | Home PIFR Monitoring |
|---|---|
| Age, Continuous | 65.1 years STANDARD_DEVIATION 8.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 69 Participants |
| Region of Enrollment United States | 80 Participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 80 |
| other Total, other adverse events | 0 / 80 |
| serious Total, serious adverse events | 22 / 80 |
Outcome results
Primary
Occurrence of Suboptimal PIFR
The occurrence of suboptimal Peak Inspiratory Flow Rate (sPIFR) over 24 weeks. sPIFR will be defined as any two consecutive measurements on different days below the optimal threshold for any prescribed DPI (e.g.,\<30 L/min for Handihaler® (High resistance DPI), \<60 L/min for Ellipta® (Medium resistance DPI))
Time frame: 24 weeks
Population: Data are reported for all participants who contributed at least 2 consecutive PIFR measurements on different days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home PIFR Monitoring | Occurrence of Suboptimal PIFR | 22.7 percentage of participants |