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Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101)
This study has been completed.
Study NCT00306163   Information provided by ALTANA Pharma
First Received: March 22, 2006   Last Updated: December 12, 2008   History of Changes

March 22, 2006
December 12, 2008
May 2006
August 2008   (final data collection date for primary outcome measure)
PC20 (AMP)(Post-treatment compared to baseline) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
PC20 (AMP)(Post–treatment compared to baseline).
Complete list of historical versions of study NCT00306163 on ClinicalTrials.gov Archive Site
  • Δ (FVC/SVC) at PC20 (AMP) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • safety and tolerability [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
  • Δ (FVC/SVC) at PC20 (AMP)
  • safety and tolerability.
 
Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101)
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.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment
Asthma
  • Drug: Ciclesonide
  • Drug: Fluticasone
  • Active Comparator: Ciclesonide 160 µg
  • Active Comparator: Fluticasone 100 µg
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
40
September 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00306163
Nycomed GmbH, Nycomed
BY9010/NL-101
ALTANA Pharma
 
Principal Investigator: D.S. Postma, Prof. University Hospital, Groningen, The Netherlands
ALTANA Pharma
December 2008

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