Phase 3
Completed N=142
Actuation Indicator Trial in Patients With COPD
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT00928746 ↗
Enrolled (actual)
142
Serious AEs
1.4%
Results posted
Sep 2010
Primary outcomePrimary: Actuations Registered by the Actuation Indicator — 167 Count
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Actuations Registered by the Actuation Indicator |
167 | — |
| PRIMARY Actuations Dispensed |
159.77 | — |
| PRIMARY Difference Between the Number of Actuations Registered by Actuation Indicator Versus Actuations Dispensed |
1.85 | — |
| SECONDARY Actuations Recorded on Patient Diary |
168 | — |
| SECONDARY Actuations Based on Advancing the Actuation Indicator |
166 | — |
| SECONDARY Actuations Registered by the Actuation Indicator and Read by Site Coordinator |
164 | — |
| SECONDARY Difference Between the Number of Actuations Recorded on Patient Diary Versus Actuations Dispensed |
5.07 | — |
| SECONDARY Difference Between the Number of Actuations Based on Advancing Actuation Indicator Versus Actuations Dispensed |
1.71 | — |
| SECONDARY Difference Between the Number of Actuations Registered by the Actuation Indicator and Read by Site Coordinator Versus Actuations Dispensed |
3.33 | — |
| SECONDARY Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire |
113; 11 | — |
| SECONDARY Number of Participants Who Reported Problems With Seeing Red Warning Indicating Inhaler Near End of Recommended Doses According to Patient Handling Questionnaire |
15; 109 | — |
| SECONDARY Number of Participants Who Reported Problems With Inhaler and Dose Counter Performing as Expected Based on Instructions According to Patient Handling Questionnaire |
5; 119 | — |
| 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 |
6; 118 | — |
| SECONDARY Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire |
6; 118 | — |
| SECONDARY Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire |
3; 121 | — |
| SECONDARY Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire |
4; 120 | — |
| SECONDARY Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire |
103; 21 | — |
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
Data sourced from ClinicalTrials.gov (NCT00928746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.