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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Device: Placebo capsule administered via the HandiHaler®; Device: Ipratropium metered dose inhaler (MDI)

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HandiHaler® vs. MDI; sequence during treatment phase: first Placebo capsule administered via HandiHaler then Ipratropium metered dose inhaler	Device: Placebo capsule administered via the HandiHaler®; Device: Ipratropium metered dose inhaler (MDI)
Experimental: MDI vs. HandiHaler®; sequence during treatment phase: first Ipratropium metered dose inhaler then Placebo capsule administered via HandiHaler Ipratropium metered dose inhaler	Device: Placebo capsule administered via the HandiHaler®; Device: Ipratropium metered dose inhaler (MDI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Performance score based on the checklist for each device	Day 0 and 28

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2000
• Primary Completion (Actual): June 1, 2001

Study Registration Dates

• First Submitted: June 20, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Ipratropium
• Other Study ID Numbers: 205.220