Pulmonary Disease, Chronic ObstructivePhase 3NCT00928746
Actuation Indicator Trial in Patients With COPD
A Phase 3 study testing Ipratropium bromide in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Ipratropium bromide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 7 sitesUnited States
- Study dates
- Jun 2009to Aug 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of COPD based on medical history at a severity to require maintenance treatment with a bronchodilator
- Male or female patients 40 years of age or older
- 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
- Must be able to use the study MDI with the mouthpiece containing actuation indicator
Who cannot join
- 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
- 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
- History of asthma
- Significant history active alcohol or drug abuse
- Known active tuberculosis
- Known narrow-angle glaucoma
Show all 11Show fewer
- Current significant psychiatric disorders
- 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®)
- Known hypersensitivity to anticholinergic drugs, any other component of the ipratropium bromide, HFA-134a or MDI components
- Previous participation in this trial
- Patients who are currently participating in another trial and/or who have received investigational drug within the past 30 days
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
244.2507.0106 Boehringer Ingelheim Investigational Site
Easley, South Carolina
244.2507.0102 Boehringer Ingelheim Investigational Site
Gaffney, South Carolina
244.2507.0104 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
244.2507.0105 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
244.2507.0107 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana
244.2507.0103 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
244.2507.0101 Boehringer Ingelheim Investigational Site
Union, South Carolina
About this study
Official title: 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Ipratropium bromide
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipratropium bromideDevice
| Study group | Role | What they receive |
|---|---|---|
| ATROVENT 42mcg | Other | Not described Receives: Device: Ipratropium bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 21 Days
Secondary outcomes (14)
Actuations Recorded on Patient Diary
Measured: 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
Measured: 21 Days
Actuations Registered by the Actuation Indicator and Read by Site Coordinator
Measured: 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)
Measured: 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)
Measured: 21 Days
Difference Between the Number of Actuations Registered by the Actuation Indicator and Read by Site Coordinator Versus Actuations Dispensed
Measured: 21 Days
Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire
Measured: 21 Days
Number of Participants Who Reported Problems With Seeing Red Warning Indicating Inhaler Near End of Recommended Doses According to Patient Handling Questionnaire
Measured: 21 Days
Number of Participants Who Reported Problems With Inhaler and Dose Counter Performing as Expected Based on Instructions According to Patient Handling Questionnaire
Measured: 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
Measured: 21 Days
Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire
Measured: 21 Days
Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire
Measured: 21 Days
Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire
Measured: 21 Days
Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire
Measured: 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928746
- Sponsor's protocol ID
- 244.2507
- Status last verified
- Jan 2014
- First submitted
- 25 Jun 2009
- Last updated
- 2 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATROVENT HFA Actuation Indicator Open-Label Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00928746
- Acronym / sponsor ID
- 244.2507
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Posted 28 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATROVENT 42mcg | Other | Device: Ipratropium bromide |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of COPD based on medical history at a severity to require maintenance treatment with a bronchodilator
- Male or female patients 40 years of age or older
- 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
- Must be able to use the study MDI with the mouthpiece containing actuation indicator
Key exclusion criteria (11 listed)
- 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
- 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
- History of asthma
- Significant history active alcohol or drug abuse
- Known active tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ipratropium bromide | Device | ATROVENT 42mcg |
Primary outcome
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)
14 secondary outcomes
Actuations Recorded on Patient Diary
Time frame: 21 Days
Actuations Based on Advancing the Actuation Indicator
Time frame: 21 Days
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 Based on Advancing Actuation Indicator Versus Actuations Dispensed
Time frame: 21 Days
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ipratropium bromide in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actuations Registered by the Actuation Indicator (time frame: 21 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2014.