Trial record 2 of 3 for:    S0709

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

This study has been withdrawn prior to enrollment.
(Study terminated prior to recruitment - recruitment proved impossible)
Information provided by:
NHS Greater Glasgow and Clyde Identifier:
First received: June 8, 2006
Last updated: July 27, 2010
Last verified: May 2006
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 Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Inhaled Tiotropium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Replacement of Nebulised Ipratropium With Inhaled Tiotropium in Stable COPD

Resource links provided by NLM:

Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • Spirometry

Secondary Outcome Measures:
  • St George's Respiratory Questionnaire
  • Baseline/Transition Dyspnea index

Estimated Enrollment: 45
Study Start Date: June 2006
Estimated Study Completion Date: December 2007
  Show Detailed Description


Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00335621

United Kingdom
Department of Respiratory Medicine, Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Principal Investigator: George W Chalmers, MD NHS Greater Glasgow and Clyde
Principal Investigator: Anne Boyter, PhD Strathclyde University
  More Information Identifier: NCT00335621     History of Changes
Other Study ID Numbers: RN05RM001  REC 05/S0709/45  SSA 05/S0704/40 
Study First Received: June 8, 2006
Last Updated: July 27, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by NHS Greater Glasgow and Clyde:

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium Bromide
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents processed this record on May 22, 2016