Responsiveness of Lower Airways in Adult Patients (18-60 y) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101)
Information source: ALTANA Pharma
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Ciclesonide (Drug); Fluticasone (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: ALTANA Pharma Official(s) and/or principal investigator(s):
D.S. Postma, Prof., Principal Investigator, Affiliation: University Hospital, Groningen, The Netherlands
Overall contact:
ALTANA Pharma Info, Email: info.clintrials@altanapharma.com
Summary
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.
Clinical Details
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.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment
Primary outcome: PC20 (AMP)(Post-treatment compared to baseline).
Secondary outcome: Δ (FVC/SVC) at PC20 (AMP)safety and tolerability.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
ALTANA Pharma Info, Email: info.clintrials@altanapharma.com
Altana Pharma/Nycomed, RB Groningen 9700, Netherlands; Recruiting
Additional Information
Starting date: May 2006
Last updated: July 16, 2008
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