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

Sponsor:	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

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:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Fluticasone Ciclesonide

U.S. FDA Resources

Further study details as provided by ALTANA Pharma:

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

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 by ALTANA Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cohen J, Postma DS, Douma WR, Vonk JM, De Boer AH, ten Hacken NH. Particle size matters: diagnostics and treatment of small airways involvement in asthma. Eur Respir J. 2011 Mar;37(3):532-40. Epub 2010 Jul 1.

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:	April 6, 2010
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by ALTANA Pharma:

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

Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012