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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306163
• Other study ID #: BY9010/NL-101
• Status: Completed
• Phase: Phase 3
• First received: March 22, 2006
• Last updated: December 2, 2016
• Start date: May 2006
• Est. completion date: September 2008

Study information

• Verified date: September 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Ciclesonide
inhaled Ciclesonide 160 µg, once daily in the morning
• Fluticasone
inhaled Fluticasone 100 µg, twice daily

Locations

Country	Name	City	State
Netherlands	Altana Pharma/Nycomed	RB Groningen

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PC20 AMP (Post-treatment Compared to Baseline)	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	Baseline and 5 weeks
Secondary	? (FVC/SVC) at PC20 (AMP)	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.	Baseline and 5 weeks
Secondary	Safety and Tolerability		5 weeks