Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101)

Official Title: “Nebulizer Trial: Evaluation of the Influence of Particle Size of Aerosolized AMP on Bronchial Responsiveness in Patients With Asthma and the Effects of Treatment With Ciclesonide Versus Fluticasone.”

The aim of this study is to compare the responsiveness of lower airways in adult patients with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily at one dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Intervention(s) in this Clinical Trial

• Drug: Ciclesonide
  • inhaled Ciclesonide 160 µg, once daily in the morning
• Drug: Fluticasone
  • inhaled Fluticasone 100 µg, twice daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Ciclesonide 160 µg
• Active Comparator: 2
  • Fluticasone 100 µg

Primary Measures

• PC20 AMP (Post-treatment Compared to Baseline)
  • Time Frame: Baseline and 5 weeks
    Safety Issue?: No

Secondary Measures

• Δ (FVC/SVC) at PC20 (AMP)
  • Time Frame: Baseline and 5 weeks
    Safety Issue?: No
• Safety and Tolerability
  • Time Frame: 5 weeks
    Safety Issue?: Yes

Main Inclusion Criteria:

• History of bronchial asthma
• FEV1 > 1.20 L
• Positive Skin Prick Test
• Not more than 500 mcg/day fluticasone propionate or equivalent for at least 28 days prior to baseline visit

Main Exclusion Criteria:

• Clinically relevant abnormal laboratory values
• Concomitant severe diseases, diseases expected to interfere with the outcome of the study and diseases which are contra-indications for the use of inhaled steroids
• Chronic obstructive pulmonary disease (COPD) and /or other relevant lung diseases
• One asthma exacerbation within 2 months or more than 3 exacerbations within the last year prior to baseline visit
• Current smokers or ex-smokers with more than 10 pack years, or having smoked within 1 year prior to baseline visit
• Positive response to saline challenge at baseline visits
• Positive bronchial hyperresponsiveness

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: ALTANA Pharma Industry

Overall Clinical Trial Officials and Contacts

D.S. Postma, Prof. Principal Investigator University Hospital, Groningen, The Netherlands  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00306163

Study ID Number: BY9010/NL-101

ClinicalTrials.gov Identifier: NCT00306163

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)