Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00860938
Recruitment Status : Completed
First Posted : March 13, 2009
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Jörg Leuppi, Cantonal Hosptal, Baselland

Tracking Information
First Submitted Date  ICMJE March 12, 2009
First Posted Date  ICMJE March 13, 2009
Results First Submitted Date  ICMJE August 4, 2017
Results First Posted Date  ICMJE July 23, 2019
Last Update Posted Date July 23, 2019
Study Start Date  ICMJE April 2007
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
Change in Lung Function (FEV1) [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 12, 2009)
Change in lung function (FEV1,FVC, FEV1/VC [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT00860938 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • The Proportion Who Complete Follow-up Without Developing an Exacerbation [ Time Frame: 12 weeks ]
  • 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.
  • Change in logRDR Mannitol [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2009)
  • The Proportion Who Complete Follow-up Without Developing an Exacerbation [ Time Frame: 12 weeks ]
  • Change in exhaled NO [ Time Frame: 12 weeks ]
  • Change in Quality of Life [ Time Frame: 12 weeks ]
  • Change in PD15 FEV1 to mannitol and RDR mannitol [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Predictor for an Additional Benefit of Inhaled Corticosteroid in Patients Treated With Tiotropium for COPD
Official Title  ICMJE Predictor for an Additional Benefit of Inhaled Corticosteroid in Patients Treated With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COPD
Intervention  ICMJE Drug: Budesonide
After 4 weeks of inhalative therapy with tiotropium (all patients), patient get randomized to receive either inhalative budesonide (1600ug per day or placebo
Other Name: Miflonide
Study Arms  ICMJE
  • Active Comparator: Budesonide
    Intervention: Drug: Budesonide
  • Placebo Comparator: Placebo
    Intervention: Drug: Budesonide
Publications * Scherr A, Schafroth Török 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2019)
90
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2009)
100
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00860938
Other Study ID Numbers  ICMJE EKBB 148/06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. Jörg Leuppi, Cantonal Hosptal, Baselland
Study Sponsor  ICMJE Cantonal Hosptal, Baselland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jörg D Leuppi, MD PhD University Hospital, Basel, Switzerland
PRS Account Cantonal Hosptal, Baselland
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP