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.
Overview
- Phase
- Phase 3
- Intervention
- Ciclesonide
- Conditions
- Asthma
- Sponsor
- AstraZeneca
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- PC20 AMP (Post-treatment Compared to Baseline)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
1
Ciclesonide 160 µg
Intervention: Ciclesonide
2
Fluticasone 100 µg
Intervention: Fluticasone
Outcomes
Primary Outcomes
PC20 AMP (Post-treatment Compared to Baseline)
Time Frame: 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 Outcomes
- Safety and Tolerability(5 weeks)
- Δ (FVC/SVC) at PC20 (AMP)(Baseline and 5 weeks)