Actuation Indicator Trial in Patients With COPD

ATROVENT HFA Actuation Indicator Open-Label Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Device: Ipratropium bromide

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Lafayette, Louisiana, United States
      • 244.2507.0107 Boehringer Ingelheim Investigational Site
  • South Carolina
    • Easley, South Carolina, United States
      • 244.2507.0106 Boehringer Ingelheim Investigational Site
    • Gaffney, South Carolina, United States
      • 244.2507.0102 Boehringer Ingelheim Investigational Site
    • Greenville, South Carolina, United States
      • 244.2507.0104 Boehringer Ingelheim Investigational Site
    • Greenville, South Carolina, United States
      • 244.2507.0105 Boehringer Ingelheim Investigational Site
    • Spartanburg, South Carolina, United States
      • 244.2507.0103 Boehringer Ingelheim Investigational Site
    • Union, South Carolina, United States
      • 244.2507.0101 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ATROVENT 42mcg	Device: Ipratropium bromide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actuations Recorded on Patient Diary		21 Days
Actuations Based on Advancing the Actuation Indicator	Actuations based on advancing the actuation indicator to a zero reading or to the next increment	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	Difference between the number of actuations recorded on patient diary and the number of actuations dispensed (calculated using weight differential and shot weight)	21 Days
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)	21 Days
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 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
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: June 25, 2009
• First Submitted That Met QC Criteria: June 25, 2009
• First Posted (Estimate): June 26, 2009

Study Record Updates

• Last Update Posted (Estimate): July 2, 2014
• Last Update Submitted That Met QC Criteria: June 23, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Bromides; Ipratropium
• Other Study ID Numbers: 244.2507