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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This study has been withdrawn prior to enrollment.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)
Sponsor:
Information provided by:
NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT00335621
First received: June 8, 2006
Last updated: July 27, 2010
Last verified: May 2006
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335621

Locations
United Kingdom
Department of Respiratory Medicine, Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Investigators
Principal Investigator: George W Chalmers, MD NHS Greater Glasgow and Clyde
Principal Investigator: Anne Boyter, PhD Strathclyde University
  More Information

No publications provided

ClinicalTrials.gov 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:
COPD
ipratropium
tiotropium

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Ipratropium
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Parasympatholytics

ClinicalTrials.gov processed this record on October 16, 2012