Pulmonary Disease, Chronic ObstructivePhase 3NCT02172404
HandiHaler® vs. Metered Dose Inhaler (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Ipratropium metered dose inhaler (MDI) in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
Trial to compare the administration technique for HandiHaler® vs. MDI, to compare the learning retention of the administration technique for the HandiHaler® vs. MDI and to compare the ease of use for HandiHaler® vs. MDI 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 metered dose inhaler (MDI)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Oct 2000to Jun 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- Historical data (not older than 6 months) of stable airway obstruction with an forced expiratory volume at one second (FEV1) ≤ 80% of predicted normal and FEV1 ≤ 70% of forced vital capacity (FVC)
- Male or female patients with 40 years of age or older
- Smokers or ex-smokers with a smoking history of more than 10 pack-years
- Currently using a prescription bronchodilator (such as Atrovent®, Berodual®, Combivent®, salbutamol, etc.) administered at least once daily
- Able to read and understand written instructions, understand verbal instructions and fill out written questionnaires regarding the devices
- Able to give informed consent prior to participation in the trial, including discontinuation of any medications, sign an approved consent form, and be willing and able to complete all trial procedures
Who cannot join
- Any acute or chronic illness which could interfere with the conduct of completion of the trial, including but not limited to cardiovascular, renal, neurologic, liver, immunologic, or endocrine dysfunction if clinically significant
- Current or recent (past 2 years) history of drug or alcohol abuse
- Participation in any other clinical trial or use if any investigational drug within the last 30 days prior to visit 1
- Experience with the HandiHaler®
- Discontinued use of regularly prescribed use of MDI within the last 12 months.
- Treatment with any oral or injectable β-blockers within the recent 4 weeks prior to visit 1
Show all 13Show fewer
- Treatment with oral β-adrenergics within the recent 4 weeks prior to visit 1
- Current or recent (last 6 weeks prior to visit 1) respiratory illness including, but not limited to upper or lower respiratory tract infections or asthma
- Patients who are in a pulmonary rehabilitation program or who had completed a pulmonary rehabilitation program in the 6 weeks prior to visit 1
- Patients with known hypersensitivity to ipratropium bromide, lactose or any other components of the inhalation capsule delivery system
- Patients with known sensitivity to inhaled β-agonists
- Patient using oral corticosteroid medication at unstable doses (i.e., less than 6 weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day
- Pregnant or nursing women or women of childbearing potential not using medically approved means of contraception
About this study
Official title: A Single-blind Two-centre Trial to Compare Administration Technique, Learning Retention of the Administration Technique and Ease of Use of the HandiHaler® With Those of the Pressurised Metered Dose Inhaler (MDI) in Patients With COPD.
Trial to compare the administration technique for HandiHaler® vs. MDI, to compare the learning retention of the administration technique for the HandiHaler® vs. MDI and to compare the ease of use for HandiHaler® vs. MDI
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Placebo capsule administered via the HandiHaler®, Ipratropium metered dose inhaler (MDI)
- 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.
Placebo capsule administered via the HandiHaler®Device
Ipratropium metered dose inhaler (MDI)Device
| Study group | Role | What they receive |
|---|---|---|
| HandiHaler® vs. MDI | Experimental | sequence during treatment phase: first Placebo capsule administered via HandiHaler then Ipratropium metered dose inhaler Receives: Device: Placebo capsule administered via the HandiHaler®; Device: Ipratropium metered dose inhaler (MDI) |
| MDI vs. HandiHaler® | Experimental | sequence during treatment phase: first Ipratropium metered dose inhaler then Placebo capsule administered via HandiHaler Ipratropium metered dose inhaler Receives: Device: Placebo capsule administered via the HandiHaler®; Device: Ipratropium metered dose inhaler (MDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance score based on the checklist for each device
Measured: Day 0 and 28
Secondary outcomes (5)
Number of errors on all scoring attempts per device use
Measured: Day 0
Number of scoring attempts per device use
Measured: Day 0
Number of incorrect answers to the "knowledge of use" questionnaire per device use
Measured: Day 28
Set of patient responses to the "ease of use" questionnaire
Measured: Day 28
Patients responses to the questionnaire
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startOct 2000
- Primary completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172404
- Sponsor's protocol ID
- 205.220
- Status last verified
- Aug 2018
- First submitted
- 20 Jun 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind Two-centre Trial to Compare Administration Technique, Learning Retention of the Administration Technique and Ease of Use of the HandiHaler® With Those of the Pressurised Metered Dose Inhaler (MDI) in Patients With COPD.
- ClinicalTrials.gov ID
- NCT02172404
- Acronym / sponsor ID
- 205.220
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2000
- Primary completion
- Jun 2001 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trial to compare the administration technique for HandiHaler® vs. MDI, to compare the learning retention of the administration technique for the HandiHaler® vs. MDI and to compare the ease of use for HandiHaler® vs. MDI
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HandiHaler® vs. MDI | Experimental | Device: Placebo capsule administered via the HandiHaler®, Device: Ipratropium metered dose inhaler (MDI)sequence during treatment phase: first Placebo capsule administered via HandiHaler then Ipratropium metered dose inhaler |
| MDI vs. HandiHaler® | Experimental | Device: Placebo capsule administered via the HandiHaler®, Device: Ipratropium metered dose inhaler (MDI)sequence during treatment phase: first Ipratropium metered dose inhaler then Placebo capsule administered via HandiHaler Ipratropium metered dose inhaler |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- Male or female patients with 40 years of age or older
- Smokers or ex-smokers with a smoking history of more than 10 pack-years
- Currently using a prescription bronchodilator (such as Atrovent®, Berodual®, Combivent®, salbutamol, etc.) administered at least once daily
- Able to read and understand written instructions, understand verbal instructions and fill out written questionnaires regarding the devices
Key exclusion criteria (13 listed)
- Any acute or chronic illness which could interfere with the conduct of completion of the trial, including but not limited to cardiovascular, renal, neurologic, liver, immunologic, or endocrine dysfunction if clinically significant
- Current or recent (past 2 years) history of drug or alcohol abuse
- Participation in any other clinical trial or use if any investigational drug within the last 30 days prior to visit 1
- Experience with the HandiHaler®
- Discontinued use of regularly prescribed use of MDI within the last 12 months.
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 |
|---|---|---|
| Placebo capsule administered via the HandiHaler® | Device | HandiHaler® vs. MDI, MDI vs. HandiHaler® |
| Ipratropium metered dose inhaler (MDI) | Device | HandiHaler® vs. MDI, MDI vs. HandiHaler® |
Primary outcome
Performance score based on the checklist for each device
Time frame: Day 0 and 28
5 secondary outcomes
Number of errors on all scoring attempts per device use
Time frame: Day 0
Number of scoring attempts per device use
Time frame: Day 0
Number of incorrect answers to the "knowledge of use" questionnaire per device use
Time frame: Day 28
Set of patient responses to the "ease of use" questionnaire
Time frame: Day 28
Patients responses to the questionnaire
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ipratropium metered dose inhaler (MDI) in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
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 7 inclusion and 13 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Performance score based on the checklist for each device (time frame: Day 0 and 28). 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 31 Aug 2018.