Actuation Indicator Trial in Patients With COPD
ATROVENT HFA Actuation Indicator Open-Label Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
142
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 25, 2009
CompletedFirst Posted
Study publicly available on registry
June 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedResults Posted
Study results publicly available
September 28, 2010
CompletedJuly 2, 2014
January 1, 2014
2 months
June 25, 2009
August 4, 2010
June 23, 2014
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (14)
Actuations Recorded on Patient Diary
21 Days
Actuations Based on Advancing the Actuation Indicator
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
21 Days
Difference Between the Number of Actuations Based on Advancing Actuation Indicator Versus Actuations Dispensed
21 Days
- +9 more secondary outcomes
Study Arms (1)
ATROVENT 42mcg
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
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
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 25, 2009
First Posted
June 26, 2009
Study Start
June 1, 2009
Primary Completion
August 1, 2009
Last Updated
July 2, 2014
Results First Posted
September 28, 2010
Record last verified: 2014-01