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

Sponsored by:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00306163

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 III

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Fluticasone Ciclesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment
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.

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

PC20 (AMP)(Post-treatment compared to baseline) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	40
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
1: Active Comparator Ciclesonide 160 µg	Drug: Ciclesonide inhaled Ciclesonide
2: Active Comparator Fluticasone 100 µg	Drug: Fluticasone inhaled Fluticasone

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

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

Locations

Netherlands
Altana Pharma/Nycomed
RB Groningen, Netherlands, 9700

Sponsors and Collaborators

ALTANA Pharma

Investigators

Principal Investigator:

D.S. Postma, Prof.

University Hospital, Groningen, The Netherlands

More Information

No publications provided

Responsible Party:	Nycomed ( Nycomed GmbH )
Study ID Numbers:	BY9010/NL-101
Study First Received:	March 22, 2006
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00306163 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by ALTANA Pharma:

Asthma
AMP
Ciclesonide
Fluticasone propionate

Study placed in the following topic categories:

Anti-Inflammatory Agents
Bronchial Diseases
Ciclesonide
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Lung Diseases, Obstructive
Hypersensitivity

Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Ciclesonide
Physiological Effects of Drugs
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009