HandiHaler® vs. Metered Dose Inhaler (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
HandiHaler® vs. MDI	Placebo capsule administered via the HandiHaler®	sequence during treatment phase: first Placebo capsule administered via HandiHaler then Ipratropium metered dose inhaler
MDI vs. HandiHaler®	Ipratropium metered dose inhaler (MDI)	sequence during treatment phase: first Ipratropium metered dose inhaler then Placebo capsule administered via HandiHaler Ipratropium metered dose inhaler
HandiHaler® vs. MDI	Ipratropium metered dose inhaler (MDI)	sequence during treatment phase: first Placebo capsule administered via HandiHaler then Ipratropium metered dose inhaler
MDI vs. HandiHaler®	Placebo capsule administered via the HandiHaler®	sequence during treatment phase: first Ipratropium metered dose inhaler then Placebo capsule administered via HandiHaler Ipratropium metered dose inhaler

Primary Outcome Measures

Name	Time	Method
Performance score based on the checklist for each device	Day 0 and 28

Secondary Outcome Measures

Name	Time	Method
Number of incorrect answers to the "knowledge of use" questionnaire per device use	Day 28
Number of scoring attempts per device use	Day 0
Set of patient responses to the "ease of use" questionnaire	Day 28
Patients responses to the questionnaire	Day 28
Number of errors on all scoring attempts per device use	Day 0

Recruitment & Eligibility