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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATROVENT 42mcg | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipratropium bromide | Device |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 244.2507.0107 Boehringer Ingelheim Investigational Site | Lafayette | Louisiana | United States | |||
| 244.2507.0106 Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | ATROVENT 42mcg | ATROVENT HFA (42 mcg)- Oral inhalation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients who were entered into this study and documented to have taken at least one dose of study medication (treated set).
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| ID | Title | Description |
|---|---|---|
| BG000 | ATROVENT 42mcg | ATROVENT HFA (42 mcg)- Oral inhalation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The primary analysis was performed using the Full Analysis Set (FAS). | Posted | Median | Standard Deviation | Count | 21 Days |
|
|
Up to 21 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ATROVENT 42mcg | ATROVENT HFA (42 mcg)- Oral inhalation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loss of consciousness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 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 |
| Easley |
| South Carolina |
| United States |
| 244.2507.0102 Boehringer Ingelheim Investigational Site | Gaffney | South Carolina | United States |
| 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 |
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Alcohol status | Number | participants |
|
| Smoking history | Number | participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
|
| Primary | Actuations Dispensed | Actuations dispensed is determined by the weight differential of the canister over the course of the study divided by the shot weight | The primary analysis was performed using the Full Analysis Set (FAS) | Posted | Median | Standard Deviation | Count | 21 Days |
|
|
|
| Primary | 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) | The primary analysis was performed using the Full Analysis Set (FAS) | Posted | Median | 95% Confidence Interval | Count | 21 Days |
|
|
|
| Secondary | Actuations Recorded on Patient Diary | This secondary analysis was performed using the Full Analysis Set (FAS). | Posted | Median | Standard Deviation | Count | 21 Days |
|
|
|
| Secondary | Actuations Based on Advancing the Actuation Indicator | Actuations based on advancing the actuation indicator to a zero reading or to the next increment | This secondary analysis was performed using the Full Analysis Set (FAS). | Posted | Median | Standard Deviation | Count | 21 Days |
|
|
|
| Secondary | Actuations Registered by the Actuation Indicator and Read by Site Coordinator | This secondary analysis was performed using the Full Analysis Set (FAS). | Posted | Median | Standard Deviation | Count | 21 Days |
|
|
|
| Secondary | 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) | This secondary analysis was performed using the Full Analysis Set (FAS). | Posted | Median | 95% Confidence Interval | Count | 21 Days |
|
|
|
| Secondary | 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) | This secondary analysis was performed using the Full Analysis Set (FAS). | Posted | Median | 95% Confidence Interval | Count | 21 Days |
|
|
|
| Secondary | Difference Between the Number of Actuations Registered by the Actuation Indicator and Read by Site Coordinator Versus Actuations Dispensed | This secondary analysis was performed using the Full Analysis Set (FAS). | Posted | Median | 95% Confidence Interval | Count | 21 Days |
|
|
|
| Secondary | Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire | This secondary analysis was performed using the Full Analysis Set (FAS). | Posted | Number | participants | 21 Days |
|
|
|
| Secondary | Number of Participants Who Reported Problems With Seeing Red Warning Indicating Inhaler Near End of Recommended Doses According to Patient Handling Questionnaire | This secondary analysis was performed using the Full Analysis Set (FAS). | Posted | Number | participants | 21 Days |
|
|
|
| Secondary | Number of Participants Who Reported Problems With Inhaler and Dose Counter Performing as Expected Based on Instructions According to Patient Handling Questionnaire | This secondary analysis was performed using the Full Analysis Set (FAS). | Posted | Number | participants | 21 Days |
|
|
|
| Secondary | 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 | This secondary analysis was performed using the Full Analysis Set (FAS). | Posted | Number | participants | 21 Days |
|
|
|
| Secondary | Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire | This secondary analysis was performed using the Full Analysis Set (FAS). | Posted | Number | participants | 21 Days |
|
|
|
| Secondary | Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire | This secondary analysis was performed using the Full Analysis Set (FAS). | Posted | Number | participants | 21 Days |
|
|
|
| Secondary | Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire | This secondary analysis was performed using the Full Analysis Set (FAS). | Posted | Number | participants | 21 Days |
|
|
|
| Secondary | Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire | This secondary analysis was performed using the Full Analysis Set (FAS). | Posted | Number | participants | 21 Days |
|
|
|
| 2 |
| 142 |
| 0 |
| 142 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |