HandiHaler® vs. Metered Dose Inhaler (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo capsule administered via the HandiHaler®
Ipratropium metered dose inhaler (MDI)
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
HandiHaler® vs. MDI
MDI vs. HandiHaler®
Arm Description
sequence during treatment phase: first Placebo capsule administered via HandiHaler then Ipratropium metered dose inhaler
sequence during treatment phase: first Ipratropium metered dose inhaler then Placebo capsule administered via HandiHaler Ipratropium metered dose inhaler
Outcomes
Primary Outcome Measures
Performance score based on the checklist for each device
Secondary Outcome Measures
Number of errors on all scoring attempts per device use
Number of scoring attempts per device use
Number of incorrect answers to the "knowledge of use" questionnaire per device use
Set of patient responses to the "ease of use" questionnaire
Patients responses to the questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02172404
Brief Title
HandiHaler® vs. Metered Dose Inhaler (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
June 2001 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HandiHaler® vs. MDI
Arm Type
Experimental
Arm Description
sequence during treatment phase: first Placebo capsule administered via HandiHaler then Ipratropium metered dose inhaler
Arm Title
MDI vs. HandiHaler®
Arm Type
Experimental
Arm Description
sequence during treatment phase: first Ipratropium metered dose inhaler then Placebo capsule administered via HandiHaler Ipratropium metered dose inhaler
Intervention Type
Device
Intervention Name(s)
Placebo capsule administered via the HandiHaler®
Intervention Type
Device
Intervention Name(s)
Ipratropium metered dose inhaler (MDI)
Primary Outcome Measure Information:
Title
Performance score based on the checklist for each device
Time Frame
Day 0 and 28
Secondary Outcome Measure Information:
Title
Number of errors on all scoring attempts per device use
Time Frame
Day 0
Title
Number of scoring attempts per device use
Time Frame
Day 0
Title
Number of incorrect answers to the "knowledge of use" questionnaire per device use
Time Frame
Day 28
Title
Set of patient responses to the "ease of use" questionnaire
Time Frame
Day 28
Title
Patients responses to the questionnaire
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.220.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.220_literature.pdf
Description
Related Info
Learn more about this trial
HandiHaler® vs. Metered Dose Inhaler (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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