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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Ciclesonide; Drug: Fluticasone

• Registration Number: NCT00306163
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-22
• Study First Submitted QC: 2006-03-22
• Study First Posted: 2006-03-23
• Study Start: 2006-05
• Primary Completion: 2008-08
• Study Completion: 2008-09
• Disposition First Submitted: 2009-11-19
• Results First Submitted: 2010-04-06
• Results First Submitted QC: 2010-04-06
• Disposition First Submitted QC: 2010-04-06
• Results First Posted: 2010-04-26
• Disposition First Posted: 2010-04-26
• Status Verified: 2016-09
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ciclesonide	Ciclesonide 160 µg
2	Fluticasone	Fluticasone 100 µg

Primary Outcome Measures

Name	Time	Method
PC20 AMP (Post-treatment Compared to Baseline)	Baseline and 5 weeks	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

Name	Time	Method
Δ (FVC/SVC) at PC20 (AMP)	Baseline and 5 weeks	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	5 weeks

Trial Locations

Locations (1)

Altana Pharma/Nycomed; 🇳🇱 RB Groningen, Netherlands