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Replacement of Nebulised Ipratropium With Inhaled Tiotropium in Stable COPD

This study is not yet open for participant recruitment.
Verified by NHS Greater Glasgow and Clyde, May 2006

Sponsored by: NHS Greater Glasgow and Clyde
Information provided by: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT00335621
  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 IV

MedlinePlus related topics:   COPD (Chronic Obstructive Pulmonary Disease)   

ChemIDplus related topics:   Tiotropium    Tiotropium bromide    Ipratropium    Ipratropium bromide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:   Replacement of Nebulised Ipratropium With Inhaled Tiotropium in Stable COPD

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  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

Contacts
Contact: George W Chalmers, MD     +44 141 211 4000 ext 4381     George.Chalmers@northglasgow.scot.nhs.uk    
Contact: Anne Boyter, PhD     +44 141 548 4594     anne.boyter@strath.ac.uk    

Locations
United Kingdom
Department of Respiratory Medicine, Glasgow Royal Infirmary     Not yet recruiting
      Glasgow, United Kingdom, G4 0SF
      Contact: George W Chalmers, MD     +44 141 211 4000 ext 4381     George.Chalmers@northglasgow.scot.nhs.uk    
      Contact: Anne Boyter, PhD     +44 141 548 4594     anne.boyter@strath.ac.uk    
      Principal Investigator: George W Chalmers, MD            

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


Study ID Numbers:   RN05RM001, REC 05/S0709/45, SSA 05/S0704/40
First Received:   June 8, 2006
Last Updated:   June 12, 2006
ClinicalTrials.gov Identifier:   NCT00335621
Health Authority:   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by NHS Greater Glasgow and Clyde:
COPD  
ipratropium  
tiotropium  

Study placed in the following topic categories:
Lung Diseases, Obstructive
Ipratropium
Respiratory Tract Diseases
Lung Diseases
Tiotropium
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Respiratory System Agents
Parasympatholytics
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cholinergic Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on October 14, 2008




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