Predictor for an Additional Benefit of Inhaled Corticosteroid in Patients Treated With Tiotropium for COPD
1 other identifier
interventional
90
1 country
1
Brief Summary
Study purpose is to evaluate if subjects with chronic obstructive pulmonary disease (COPD) are more likely to be responsive to additional inhaled corticosteroids if they have a positive response to hyperosmolar challenge with mannitol than if their response is negative.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 12, 2009
CompletedFirst Posted
Study publicly available on registry
March 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
July 23, 2019
CompletedJuly 23, 2019
July 1, 2019
3.3 years
March 12, 2009
August 4, 2017
July 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Lung Function (FEV1)
12 weeks
Secondary Outcomes (3)
The Proportion Who Complete Follow-up Without Developing an Exacerbation
12 weeks
Change in Quality of Life
12 weeks, baseline to 3 months follow-up
Change in logRDR Mannitol
12 weeks
Study Arms (2)
Budesonide
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
After 4 weeks of inhalative therapy with tiotropium (all patients), patient get randomized to receive either inhalative budesonide (1600ug per day or placebo
Eligibility Criteria
You may qualify if:
- FEV1/FVC \< 70%
- FEV1 % predicted \> 60%
You may not qualify if:
- Other major disease
- Asthma
- Currently taking inhaled corticosteroids
- oral corticosteroids in the last 3 month
- significant cardiovascular disease
- pregnancy/breast feeding
- current use of salmeterol or other long acting bronchodilator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Basel
Basel, 4031, Switzerland
Related Publications (1)
Scherr A, Schafroth Torok S, Jochmann A, Miedinger D, Maier S, Taegtmeyer AB, Chhajed PN, Tamm M, Leuppi JD. Response to add-on inhaled corticosteroids in COPD based on airway hyperresponsiveness to mannitol. Chest. 2012 Oct;142(4):919-926. doi: 10.1378/chest.11-2535.
PMID: 22459771DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The dropout rate of 24% was relatively high. A further limitation of the study might be the lack of data for sputum eosinophilia.
Results Point of Contact
- Title
- Jörg D. Leuppi, MD PhD, principle investigator
- Organization
- University Hospital Basel, Switzerland
Study Officials
- PRINCIPAL INVESTIGATOR
Jörg D Leuppi, MD PhD
University Hospital, Basel, Switzerland
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
March 12, 2009
First Posted
March 13, 2009
Study Start
April 1, 2007
Primary Completion
August 1, 2010
Study Completion
October 1, 2010
Last Updated
July 23, 2019
Results First Posted
July 23, 2019
Record last verified: 2019-07