Actuation Indicator Trial in Patients With COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928746
• Other study ID #: 244.2507
• Status: Completed
• Phase: Phase 3
• First received: June 25, 2009
• Last updated: June 23, 2014
• Start date: June 2009

Study information

• Verified date: January 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Ipratropium bromide

Locations

Country	Name	City	State
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	244.2507.0107 Boehringer Ingelheim Investigational Site	Lafayette	Louisiana
United States	244.2507.0103 Boehringer Ingelheim Investigational Site	Spartanburg	South Carolina
United States	244.2507.0101 Boehringer Ingelheim Investigational Site	Union	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Actuations Recorded on Patient Diary		21 Days	No
Secondary	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	No
Secondary	Actuations Registered by the Actuation Indicator and Read by Site Coordinator		21 Days	No
Secondary	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	No
Secondary	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	No
Secondary	Difference Between the Number of Actuations Registered by the Actuation Indicator and Read by Site Coordinator Versus Actuations Dispensed		21 Days	No
Secondary	Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire		21 Days	No
Secondary	Number of Participants Who Reported Problems With Seeing Red Warning Indicating Inhaler Near End of Recommended Doses According to Patient Handling Questionnaire		21 Days	No
Secondary	Number of Participants Who Reported Problems With Inhaler and Dose Counter Performing as Expected Based on Instructions According to Patient Handling Questionnaire		21 Days	No
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		21 Days	No
Secondary	Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire		21 Days	No
Secondary	Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire		21 Days	No
Secondary	Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire		21 Days	No
Secondary	Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire		21 Days	No

External Links

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