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.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00306163
First received: March 22, 2006
Last updated: May 4, 2012
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Ciclesonide
Drug: Fluticasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • PC20 AMP (Post-treatment Compared to Baseline) [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]

    Mean change of Provocative concentration of Adenosine-5'-monophosphate (PC20 AMP) leading to a 20 percent decrease in Forced expiratory volume in one second (FEV1) between post-treatment and baseline using two different particle sizes.

    • Small particles = Mass mean aerodynamic diameter (MMAD) of approximately 1.04-1.08 micron
    • Large particles = MMAD of approximately 9.9-10.6 micron


Secondary Outcome Measures:
  • Δ (FVC/SVC) at PC20 (AMP) [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
    Change between baseline and post-treatment of the ratio of Forced Vital Capacity (FVC) and Slow Vital Capacity at PC20. Measured with either small or large partical size AMP.

  • Safety and Tolerability [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: May 2006
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Ciclesonide 160 µg
Drug: Ciclesonide
inhaled Ciclesonide 160 µg, once daily in the morning
Active Comparator: 2
Fluticasone 100 µg
Drug: Fluticasone
inhaled Fluticasone 100 µg, twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306163

Locations
Netherlands
Altana Pharma/Nycomed
RB Groningen, Netherlands, 9700
Sponsors and Collaborators
Takeda
Investigators
Principal Investigator: D.S. Postma, Prof. University Hospital, Groningen, The Netherlands
  More Information

No publications provided by Takeda

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nycomed GmbH, Nycomed
ClinicalTrials.gov Identifier: NCT00306163     History of Changes
Other Study ID Numbers: BY9010/NL-101
Study First Received: March 22, 2006
Results First Received: April 6, 2010
Last Updated: May 4, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Takeda:
Asthma
AMP
Ciclesonide
Fluticasone propionate

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Ciclesonide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014