Phase 4
Completed N=90
Predictor for an Additional Benefit of Inhaled Corticosteroid in Patients Treated With Tiotropium for COPD
Source: ClinicalTrials.gov NCT00860938 ↗Enrolled (actual)
90
Serious AEs
4.4%
Results posted
Jul 2019
Primary outcomePrimary: Change in Lung Function (FEV1) — 0.05; -0.05 litres
◆ Published Evidence
Emerging
19citations · ~1 / year
Response to add-on inhaled corticosteroids in COPD based on airway hyperresponsiveness to mannitol.
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.
Linked Publications
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Response to add-on inhaled corticosteroids in COPD based on airway hyperresponsiveness to mannitol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Lung Function (FEV1) |
0.05; -0.05 | — |
| SECONDARY The Proportion Who Complete Follow-up Without Developing an Exacerbation |
31; 37 | — |
| SECONDARY Change in Quality of Life |
5.1; 1.8 | — |
| SECONDARY Change in logRDR Mannitol |
0.12; -0.09 | — |
Eligibility Criteria
Inclusion Criteria
- FEV1/FVC 60%
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00860938) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.