Clinical trial NCT00860938: Predictor for an Additional Benefit of Inhaled Corticosteroid in Patients Treated With Tiotropium for COPD
Official title: Predictor for an Additional Benefit of Inhaled Corticosteroid in Patients Treated With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Keywords: Inhaled corticosteroids
COPD
mannitol
Lead sponsor: Cantonal Hosptal, Baselland
Sponsor class: OTHER
First posted: 2009-03-13
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: In patients with chronic obstructive pulmonary disease (COPD), the treatment with inhaled corticosteroids (ICS) is controversial. Preliminary results of our recent pilot study in 30 COPD patients showed for the first time, that ICS response mey be predicted by a bronchoprovocation challenge test with mannitol. However, this finding needs to be proven in a placebo-controlled trial. For this cohort study, 100 corticosteroid-naive, non reversible (FEV1) patients with COPD will be recruited. Spirometry before and after bronchodilation will be measured at study entry and at four weeks run-in (only tiotropium) and at three month of treatment with tiotropium and ICS or placebo. Quality of life (St. George Respiratory Quality of Life Questionnaire) and exacerbation rate of COPD will be assessed. Measurement of exhaled nitric oxide and mannitol challenge will be performed at study entry and at 1 and 4 month. Primary endpoint will be improvement in FEV1 in each group (positive and negative mannitol challenge) after 3 months follow up. Secondary endpoints will be the difference in dose-response-curve in the mannitol challenge, exacerbation rate and change in quality of life after three month follow-up.

Eligibility criteria: Inclusion Criteria:

* FEV1/FVC \< 70%
* FEV1 % predicted \> 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

Primary outcomes:
measure: Change in Lung Function (FEV1)
timeFrame: 12 weeks
Secondary outcomes:
measure: The Proportion Who Complete Follow-up Without Developing an Exacerbation
timeFrame: 12 weeks
measure: Change in Quality of Life
timeFrame: 12 weeks, baseline to 3 months follow-up
measure: Change in logRDR Mannitol
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Jörg D Leuppi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.