Actuation Indicator Trial in Patients With COPD

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Device: Ipratropium bromide

• Registration Number: NCT00928746
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-25
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Primary Completion: 2009-08
• Results First Submitted: 2010-08-04
• Results First Submitted QC: 2010-09-08
• Results First Posted: 2010-09-28
• Status Verified: 2014-01
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. A diagnosis of COPD based on medical history at a severity to require maintenance treatment with a bronchodilator
2. Male or female patients 40 years of age or older
3. 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
4. Must be able to use the study MDI with the mouthpiece containing actuation indicator

Read More

Exclusion Criteria

1. 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
2. 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
3. History of asthma
4. Significant history active alcohol or drug abuse
5. Known active tuberculosis
6. Known narrow-angle glaucoma
7. Current significant psychiatric disorders
8. 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®)
9. Known hypersensitivity to anticholinergic drugs, any other component of the ipratropium bromide, HFA-134a or MDI components
10. Previous participation in this trial
11. Patients who are currently participating in another trial and/or who have received investigational drug within the past 30 days

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ATROVENT 42mcg	Ipratropium bromide	-

Primary Outcome Measures

Name	Time	Method
Actuations Registered by the Actuation Indicator	21 Days	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	21 Days	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	21 Days	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

Name	Time	Method
Actuations Recorded on Patient Diary	21 Days
Difference Between the Number of Actuations Recorded on Patient Diary Versus Actuations Dispensed	21 Days	Difference between the number of actuations recorded on patient diary and the number of actuations dispensed (calculated using weight differential and shot weight)
Actuations Registered by the Actuation Indicator and Read by Site Coordinator	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
Actuations Based on Advancing the Actuation Indicator	21 Days	Actuations based on advancing the actuation indicator to a zero reading or to the next increment
Difference Between the Number of Actuations Based on Advancing Actuation Indicator Versus Actuations Dispensed	21 Days	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	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 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

Trial Locations

Locations (7)

244.2507.0103 Boehringer Ingelheim Investigational Site; 🇺🇸 Spartanburg, South Carolina, United States

244.2507.0104 Boehringer Ingelheim Investigational Site; 🇺🇸 Greenville, South Carolina, United States

244.2507.0101 Boehringer Ingelheim Investigational Site; 🇺🇸 Union, South Carolina, United States

244.2507.0102 Boehringer Ingelheim Investigational Site; 🇺🇸 Gaffney, South Carolina, United States

244.2507.0106 Boehringer Ingelheim Investigational Site; 🇺🇸 Easley, South Carolina, United States

244.2507.0107 Boehringer Ingelheim Investigational Site; 🇺🇸 Lafayette, Louisiana, United States

244.2507.0105 Boehringer Ingelheim Investigational Site; 🇺🇸 Greenville, South Carolina, United States