Actuation Indicator Trial in Patients With COPD
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ipratropium bromide
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
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
Sites / Locations
- 244.2507.0107 Boehringer Ingelheim Investigational Site
- 244.2507.0106 Boehringer Ingelheim Investigational Site
- 244.2507.0102 Boehringer Ingelheim Investigational Site
- 244.2507.0104 Boehringer Ingelheim Investigational Site
- 244.2507.0105 Boehringer Ingelheim Investigational Site
- 244.2507.0103 Boehringer Ingelheim Investigational Site
- 244.2507.0101 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ATROVENT 42mcg
Arm Description
Outcomes
Primary Outcome Measures
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
Actuations Dispensed
Actuations dispensed is determined by the weight differential of the canister over the course of the study divided by the shot weight
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)
Secondary Outcome Measures
Actuations Recorded on Patient Diary
Actuations Based on Advancing the Actuation Indicator
Actuations based on advancing the actuation indicator to a zero reading or to the next increment
Actuations Registered by the Actuation Indicator and Read by Site Coordinator
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)
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)
Difference Between the Number of Actuations Registered by the Actuation Indicator and Read by Site Coordinator Versus Actuations Dispensed
Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire
Number of Participants Who Reported Problems With Seeing Red Warning Indicating Inhaler Near End of Recommended Doses According to Patient Handling Questionnaire
Number of Participants Who Reported Problems With Inhaler and Dose Counter Performing as Expected Based on Instructions According to Patient Handling Questionnaire
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
Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire
Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire
Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire
Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00928746
Brief Title
Actuation Indicator Trial in Patients With COPD
Official Title
ATROVENT HFA Actuation Indicator Open-Label Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ATROVENT 42mcg
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Ipratropium bromide
Primary Outcome Measure Information:
Title
Actuations Registered by the Actuation Indicator
Description
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
Title
Actuations Dispensed
Description
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
Title
Difference Between the Number of Actuations Registered by Actuation Indicator Versus Actuations Dispensed
Description
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
Secondary Outcome Measure Information:
Title
Actuations Recorded on Patient Diary
Time Frame
21 Days
Title
Actuations Based on Advancing the Actuation Indicator
Description
Actuations based on advancing the actuation indicator to a zero reading or to the next increment
Time Frame
21 Days
Title
Actuations Registered by the Actuation Indicator and Read by Site Coordinator
Time Frame
21 Days
Title
Difference Between the Number of Actuations Recorded on Patient Diary Versus Actuations Dispensed
Description
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
Title
Difference Between the Number of Actuations Based on Advancing Actuation Indicator Versus Actuations Dispensed
Description
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
Title
Difference Between the Number of Actuations Registered by the Actuation Indicator and Read by Site Coordinator Versus Actuations Dispensed
Time Frame
21 Days
Title
Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire
Time Frame
21 Days
Title
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
Title
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
Title
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
Title
Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire
Time Frame
21 Days
Title
Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire
Time Frame
21 Days
Title
Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire
Time Frame
21 Days
Title
Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire
Time Frame
21 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
244.2507.0107 Boehringer Ingelheim Investigational Site
City
Lafayette
State/Province
Louisiana
Country
United States
Facility Name
244.2507.0106 Boehringer Ingelheim Investigational Site
City
Easley
State/Province
South Carolina
Country
United States
Facility Name
244.2507.0102 Boehringer Ingelheim Investigational Site
City
Gaffney
State/Province
South Carolina
Country
United States
Facility Name
244.2507.0104 Boehringer Ingelheim Investigational Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
244.2507.0105 Boehringer Ingelheim Investigational Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
244.2507.0103 Boehringer Ingelheim Investigational Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
244.2507.0101 Boehringer Ingelheim Investigational Site
City
Union
State/Province
South Carolina
Country
United States
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/244/244.2507_U10-3384-01-DS.pdf
Description
Related Info
Learn more about this trial
Actuation Indicator Trial in Patients With COPD
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