The primary objective of this study is to evaluate the performance, accuracy, and handling of the actuation indicator in patients with COPD. The actuation indicator is integrated into mouthpiece of the ipratropium bromide HFA inhalation aerosol device. As part of Boehringer Ingelheim's program to qualify an actuation indicator for use with the ipratropium bromide HFA inhalation aerosol device, this study is intended to complement the results from the ongoing in-vitro studies.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
142
244.2507.0107 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana, United States
244.2507.0106 Boehringer Ingelheim Investigational Site
Easley, South Carolina, United States
244.2507.0102 Boehringer Ingelheim Investigational Site
Gaffney, South Carolina, United States
Actuations Registered by the Actuation Indicator
This outcome measure presents the number of actuations (doses) of medication used in the specific time frame as measured by the actuation indicator
Time frame: 21 Days
Actuations Dispensed
Actuations dispensed is determined by the weight differential of the canister over the course of the study divided by the shot weight
Time frame: 21 Days
Difference Between the Number of Actuations Registered by Actuation Indicator Versus Actuations Dispensed
Difference between the number of actuations registered by the actuation indicator and the number of actuations dispensed (calculated using weight differential and shot weight)
Time frame: 21 Days
Actuations Recorded on Patient Diary
Time frame: 21 Days
Actuations Based on Advancing the Actuation Indicator
Actuations based on advancing the actuation indicator to a zero reading or to the next increment
Time frame: 21 Days
Actuations Registered by the Actuation Indicator and Read by Site Coordinator
Time frame: 21 Days
Difference Between the Number of Actuations Recorded on Patient Diary Versus Actuations Dispensed
Difference between the number of actuations recorded on patient diary and the number of actuations dispensed (calculated using weight differential and shot weight)
Time frame: 21 Days
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244.2507.0104 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
244.2507.0105 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
244.2507.0103 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
244.2507.0101 Boehringer Ingelheim Investigational Site
Union, South Carolina, United States
Difference Between the Number of Actuations Based on Advancing Actuation Indicator Versus Actuations Dispensed
Difference between the number of actuations based on advancing the actuation indicator to a zero reading or to the next increment and the number of actuations dispensed (calculated using weight differential and shot weight)
Time frame: 21 Days
Difference Between the Number of Actuations Registered by the Actuation Indicator and Read by Site Coordinator Versus Actuations Dispensed
Time frame: 21 Days
Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire
Time frame: 21 Days
Number of Participants Who Reported Problems With Seeing Red Warning Indicating Inhaler Near End of Recommended Doses According to Patient Handling Questionnaire
Time frame: 21 Days
Number of Participants Who Reported Problems With Inhaler and Dose Counter Performing as Expected Based on Instructions According to Patient Handling Questionnaire
Time frame: 21 Days
Number of Participants Who Reported Satisfaction With Performance of the Dose Counter for Indicating Approximately How Many Doses Remain in Inhaler According to Patient Handling Questionnaire
Time frame: 21 Days
Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire
Time frame: 21 Days
Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire
Time frame: 21 Days
Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire
Time frame: 21 Days
Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire
Time frame: 21 Days