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Actuation Indicator Trial in Patients With COPD

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ClinicalTrials.gov Identifier: NCT00928746
Recruitment Status : Completed
First Posted : June 26, 2009
Results First Posted : September 28, 2010
Last Update Posted : July 2, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

June 25, 2009
June 26, 2009
August 4, 2010
September 28, 2010
July 2, 2014
June 2009
August 2009   (Final data collection date for primary outcome measure)
  • Actuations Registered by the Actuation Indicator [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)
The primary endpoint is the difference between the number of inhalations registered by the actuation indicator device (read by BIPI technician)and the number of inhalations dispensed based upon the weight differential of the canister . [ Time Frame: 21 Days ]
Complete list of historical versions of study NCT00928746 on ClinicalTrials.gov Archive Site
  • Actuations Recorded on Patient Diary [ Time Frame: 21 Days ]
  • Actuations Based on Advancing the Actuation Indicator [ Time Frame: 21 Days ]
    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 ]
  • Difference Between the Number of Actuations Recorded on Patient Diary Versus Actuations Dispensed [ Time Frame: 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)
  • Difference Between the Number of Actuations Based on Advancing Actuation Indicator Versus Actuations Dispensed [ Time Frame: 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 [ Time Frame: 21 Days ]
  • Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire [ Time Frame: 21 Days ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire [ Time Frame: 21 Days ]
  • Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire [ Time Frame: 21 Days ]
  • Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire [ Time Frame: 21 Days ]
  • Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire [ Time Frame: 21 Days ]
The difference between the number of inhalations based on the patient diary (containing the record of doses taken each day) and the number of inhalations dispensed .
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 3
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
Device: Ipratropium bromide
ATROVENT 42mcg
Intervention: Device: Ipratropium bromide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
142
140
Not Provided
August 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00928746
244.2507
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP