Actuation Indicator Trial in Patients With COPD

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Device: Ipratropium bromide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00928746

244.2507

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

142 participants in 1 patient group

ATROVENT 42mcg

Other group

Treatment:

Device: Ipratropium bromide