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

NCT00335621 | Withdrawn Phase 4

• 3 other identifiers: RN05RM001REC 05/S0709/45SSA 05/S0704/40
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; ipratropium; tiotropium

Outcome Measures

Primary Outcomes (1)

• Spirometry

Secondary Outcomes (2)

• St George's Respiratory Questionnaire

• Baseline/Transition Dyspnea index

Interventions

Inhaled Tiotropium DRUG

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (1)

Department of Respiratory Medicine, Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• George W Chalmers, MD

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

• Anne Boyter, PhD

  Strathclyde University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 8, 2006
• First Posted: June 12, 2006
• Study Start: June 1, 2006
• Study Completion: December 1, 2007
• Last Updated: July 28, 2010

Record last verified: 2006-05

Locations

GB (1)