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Replacement of Nebulised Ipratropium With Inhaled Tiotropium in Stable Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00335621
Recruitment Status : Withdrawn (Study terminated prior to recruitment - recruitment proved impossible)
First Posted : June 12, 2006
Last Update Posted : July 28, 2010
Information provided by:
NHS Greater Glasgow and Clyde

Brief Summary:
Some patients with chronic obstructive pulmonary disease (COPD) take nebulised treatments to ease the symptom of breathlessness, including the drug ipratropium. Nebulised bronchodilator drugs are taken up to 4 times through the day, and this can take up to 15 minutes each time. Although the treatment isbe effective, patients report that the time taken to set-up and use the nebuliser can be a disincentive to regular use. By contrast, an inhaler device is easy to use following appropriate instruction, and takes only a few seconds to administer. Inhaled tiotropium is a once daily treatment taken by inhaler which has been shown to be effective in COPD. We wish to assess whether inhaled Tiotropium as effective as nebulised ipratropium in patients with stable chronic obstructive pulmonary disease.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Inhaled Tiotropium Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Replacement of Nebulised Ipratropium With Inhaled Tiotropium in Stable COPD
Study Start Date : June 2006
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Primary Outcome Measures :
  1. Spirometry

Secondary Outcome Measures :
  1. St George's Respiratory Questionnaire
  2. Baseline/Transition Dyspnea index

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stable Moderate to severe COPD (GOLD criteria)
  • > 20 pack year smoking history
  • current treatment with nebulised ipratropium bromide
  • no exacerbations within preceding 3 months

Exclusion Criteria:

  • current participation in other study
  • < 20 pack year smoking history
  • Significant co-morbidity e.g. cardiac
  • history of intolerance to lactose

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00335621

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United Kingdom
Department of Respiratory Medicine, Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
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Principal Investigator: George W Chalmers, MD NHS Greater Glasgow and Clyde
Principal Investigator: Anne Boyter, PhD Strathclyde University
Layout table for additonal information Identifier: NCT00335621    
Other Study ID Numbers: RN05RM001
REC 05/S0709/45
SSA 05/S0704/40
First Posted: June 12, 2006    Key Record Dates
Last Update Posted: July 28, 2010
Last Verified: May 2006
Keywords provided by NHS Greater Glasgow and Clyde:
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium Bromide
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