Actuation Indicator Trial in Patients With COPD

Study Overview
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Brief Summary
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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.

Official Title
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ATROVENT HFA Actuation Indicator Open-Label Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: Ipratropium bromide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of COPD based on medical history at a severity to require maintenance treatment with a bronchodilator Male or female patients 40 years of age or older A smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year Must be able to use the study MDI with the mouthpiece containing actuation indicator Exclusion Criteria: Significant diseases other than COPD are excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study Malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last three months. Patients with treated basal cell carcinoma are allowed History of asthma Significant history active alcohol or drug abuse Known active tuberculosis Known narrow-angle glaucoma Current significant psychiatric disorders Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices or diaphragm with spermicide, or Norplant®) Known hypersensitivity to anticholinergic drugs, any other component of the ipratropium bromide, HFA-134a or MDI components Previous participation in this trial Patients who are currently participating in another trial and/or who have received investigational drug within the past 30 days

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ATROVENT 42mcg<br> | Device: Ipratropium bromide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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) | 21 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actuations Recorded on Patient Diary |  | 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 | 21 Days | 
| Actuations Registered by the Actuation Indicator and Read by Site Coordinator |  | 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) | 21 Days | 
| 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) | 21 Days | 
| Difference Between the Number of Actuations Registered by the Actuation Indicator and Read by Site Coordinator Versus Actuations Dispensed |  | 21 Days | 
| Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire |  | 21 Days | 
| Number of Participants Who Reported Problems With Seeing Red Warning Indicating Inhaler Near End of Recommended Doses According to Patient Handling Questionnaire |  | 21 Days | 
| Number of Participants Who Reported Problems With Inhaler and Dose Counter Performing as Expected Based on Instructions According to Patient Handling Questionnaire |  | 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 |  | 21 Days | 
| Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire |  | 21 Days | 
| Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire |  | 21 Days | 
| Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire |  | 21 Days | 
| Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire |  | 21 Days |