Actuation Indicator Trial in Patients With COPD

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00928746
First received: June 25, 2009
Last updated: June 23, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Device: Ipratropium bromide
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
Official Title: ATROVENT HFA Actuation Indicator Open-Label Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Actuations Registered by the Actuation Indicator [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
    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:
  • Actuations Recorded on Patient Diary [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
  • Actuations Based on Advancing the Actuation Indicator [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
    Actuations based on advancing the actuation indicator to a zero reading or to the next increment

  • Actuations Registered by the Actuation Indicator and Read by Site Coordinator [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
  • Difference Between the Number of Actuations Recorded on Patient Diary Versus Actuations Dispensed [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
    Difference between the number of actuations recorded on patient diary and the number of actuations dispensed (calculated using weight differential and shot weight)

  • Difference Between the Number of Actuations Based on Advancing Actuation Indicator Versus Actuations Dispensed [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
  • Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
  • Number of Participants Who Reported Problems With Seeing Red Warning Indicating Inhaler Near End of Recommended Doses According to Patient Handling Questionnaire [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
  • Number of Participants Who Reported Problems With Inhaler and Dose Counter Performing as Expected Based on Instructions According to Patient Handling Questionnaire [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
  • Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
  • Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
  • Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
  • Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire [ Time Frame: 21 Days ] [ Designated as safety issue: No ]

Enrollment: 142
Study Start Date: June 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ATROVENT 42mcg Device: Ipratropium bromide

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928746

Locations
United States, Louisiana
244.2507.0107 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana, United States
United States, South Carolina
244.2507.0106 Boehringer Ingelheim Investigational Site
Easley, South Carolina, United States
244.2507.0102 Boehringer Ingelheim Investigational Site
Gaffney, South Carolina, United States
244.2507.0105 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
244.2507.0104 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
244.2507.0103 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
244.2507.0101 Boehringer Ingelheim Investigational Site
Union, South Carolina, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00928746     History of Changes
Other Study ID Numbers: 244.2507
Study First Received: June 25, 2009
Results First Received: August 4, 2010
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Bromides
Ipratropium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014