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Trial record 60 of 150 for:    Ipratropium OR atrovent

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

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ClinicalTrials.gov Identifier: NCT02172404
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Device: Placebo capsule administered via the HandiHaler® Device: Ipratropium metered dose inhaler (MDI) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : October 2000
Actual Primary Completion Date : June 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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)



Primary Outcome Measures :
  1. Performance score based on the checklist for each device [ Time Frame: Day 0 and 28 ]

Secondary Outcome Measures :
  1. Number of errors on all scoring attempts per device use [ Time Frame: Day 0 ]
  2. Number of scoring attempts per device use [ Time Frame: Day 0 ]
  3. Number of incorrect answers to the "knowledge of use" questionnaire per device use [ Time Frame: Day 28 ]
  4. Set of patient responses to the "ease of use" questionnaire [ Time Frame: Day 28 ]
  5. Patients responses to the questionnaire [ Time Frame: Day 28 ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02172404     History of Changes
Other Study ID Numbers: 205.220
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Ipratropium
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action