Predictor for an Additional Benefit of Inhaled Corticosteroid in Patients Treated With Tiotropium for COPD

Cantonal Hosptal, Baselland

Status and phase: Completed; Phase 4

Conditions: COPD

Treatments: Drug: Budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT00860938

EKBB 148/06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

Budesonide

Active Comparator group

Treatment:

Drug: Budesonide

Placebo

Placebo Comparator group

Treatment:

Drug: Budesonide