Asthma
Conditions
Keywords
Asthma, AMP, Ciclesonide, Fluticasone propionate
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.
Interventions
DRUGCiclesonide
inhaled Ciclesonide 160 µg, once daily in the morning
DRUGFluticasone
inhaled Fluticasone 100 µg, twice daily
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Netherlands
Participant flow
Pre-assignment details
A total of 101 subjects gave Informed Consent. 64 subjects did not enter or discontinued the study due to various reasons.
Participants by arm
| Arm | Count |
|---|---|
| Ciclesonide 160 µg, once daily | 19 |
| Fluticasone 100 µg, twice daily | 18 |
| Total | 37 |
Baseline characteristics
| Characteristic | Ciclesonide | Fluticasone | Total |
|---|---|---|---|
| Age, Continuous | 39.61 years INTER_QUARTILE_RANGE 10.5 | 46.02 years INTER_QUARTILE_RANGE 9.8 | 42.25 years INTER_QUARTILE_RANGE 10.16 |
| Gender Female | 13 Participants | 8 Participants | 21 Participants |
| Gender Male | 6 Participants | 10 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 19 | 2 / 18 |
| serious Total, serious adverse events | 0 / 19 | 0 / 18 |
Outcome results
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
Time frame: Baseline and 5 weeks
Population: The analyses on treatment effects were performed on all subjects who reached a PC20\<640mg/mL.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide | PC20 AMP (Post-treatment Compared to Baseline) | Post-Treatment PC20 small-particle AMP | 6.6 Logarithm (mg/mL) | Standard Deviation 2 |
| Ciclesonide | PC20 AMP (Post-treatment Compared to Baseline) | Baseline PC20 small-particle AMP | 4.9 Logarithm (mg/mL) | Standard Deviation 3.7 |
| Ciclesonide | PC20 AMP (Post-treatment Compared to Baseline) | Post-Treatment PC20 large-particle AMP | 4.5 Logarithm (mg/mL) | Standard Deviation 2.3 |
| Ciclesonide | PC20 AMP (Post-treatment Compared to Baseline) | Baseline PC20 large-particle AMP | 3.7 Logarithm (mg/mL) | Standard Deviation 2.6 |
| Fluticasone | PC20 AMP (Post-treatment Compared to Baseline) | Post-Treatment PC20 large-particle AMP | 4.3 Logarithm (mg/mL) | Standard Deviation 2.4 |
| Fluticasone | PC20 AMP (Post-treatment Compared to Baseline) | Baseline PC20 small-particle AMP | 5.2 Logarithm (mg/mL) | Standard Deviation 2.1 |
| Fluticasone | PC20 AMP (Post-treatment Compared to Baseline) | Post-Treatment PC20 small-particle AMP | 6.0 Logarithm (mg/mL) | Standard Deviation 2.7 |
| Fluticasone | PC20 AMP (Post-treatment Compared to Baseline) | Baseline PC20 large-particle AMP | 3.0 Logarithm (mg/mL) | Standard Deviation 2.4 |
Secondary
Safety and Tolerability
Time frame: 5 weeks
Secondary
Δ (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.
Time frame: Baseline and 5 weeks