Actuation Indicator Trial in Patients With COPD
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00928746
First received: June 25, 2009
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Device: Ipratropium bromide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Primary Purpose: Treatment |
| Official Title: | ATROVENT HFA Actuation Indicator Open-Label Study in Adults With Chronic Obstructive Pulmonary Disease (COPD) |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for:
Ipratropium bromide
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Actuations Registered by the Actuation Indicator [ Time Frame: 21 Days ] [ Designated as safety issue: No ]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 [ Time Frame: 21 Days ] [ Designated as safety issue: No ]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 [ Time Frame: 21 Days ] [ Designated as safety issue: No ]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 [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
- Actuations Based on Advancing the Actuation Indicator [ Time Frame: 21 Days ] [ Designated as safety issue: No ]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 [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
- Difference Between the Number of Actuations Recorded on Patient Diary Versus Actuations Dispensed [ Time Frame: 21 Days ] [ Designated as safety issue: No ]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 [ Time Frame: 21 Days ] [ Designated as safety issue: No ]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 [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
- Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
- Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
- Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
- Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
| Enrollment: | 142 |
| Study Start Date: | June 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| ATROVENT 42mcg | Device: Ipratropium bromide |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928746
Locations
| United States, Louisiana | |
| 244.2507.0107 Boehringer Ingelheim Investigational Site | |
| Lafayette, Louisiana, United States | |
| United States, South Carolina | |
| 244.2507.0106 Boehringer Ingelheim Investigational Site | |
| Easley, South Carolina, United States | |
| 244.2507.0102 Boehringer Ingelheim Investigational Site | |
| Gaffney, South Carolina, United States | |
| 244.2507.0105 Boehringer Ingelheim Investigational Site | |
| Greenville, South Carolina, United States | |
| 244.2507.0104 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 | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00928746 History of Changes |
| Other Study ID Numbers: | 244.2507 |
| Study First Received: | June 25, 2009 |
| Results First Received: | August 4, 2010 |
| Last Updated: | May 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases Bromides Ipratropium Anticonvulsants Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013