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Completed

NCT Number: NCT00860938

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

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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide

Drug

After 4 weeks of inhalative therapy with tiotropium (all patients), patient get randomized to receive either inhalative budesonide (1600ug per day or placebo

Other names: Miflonide

Primary outcomes

  1. Change in Lung Function (FEV1)

    Time frame: 12 weeks

Secondary outcomes

  1. The Proportion Who Complete Follow-up Without Developing an Exacerbation

    Time frame: 12 weeks

  2. Change in Quality of Life

    Time frame: 12 weeks, baseline to 3 months follow-up

    St. George Respiratory Questionnaire (SGRQ). Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.

    Scores are calculated for three domains: Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale) Scores range from 0 to 100, with higher scores indicating more limitations. Unit of Measure = Units on a scale A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing.

    Based on empirical data and interviews with patients, a mean change score of 4 units is associated with slightly efficacious treatment, 8 units for moderately efficacious change and 12 units for very efficacious treatment. The higher the change in units, the better the treatment.

  3. Change in logRDR Mannitol

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Cantonal Hosptal, Baselland

Other

Registry information

Official study title

Predictor for an Additional Benefit of Inhaled Corticosteroid in Patients Treated With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Mar 13, 2009
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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