Trial Outcomes & Findings for Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101) (NCT NCT00306163)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

37 participants

Primary outcome timeframe

Baseline and 5 weeks

Results posted on

2017-02-01

Participant Flow

A total of 101 subjects gave Informed Consent. 64 subjects did not enter or discontinued the study due to various reasons.

Participant milestones

Participant milestones
Measure	Ciclesonide 160 µg, once daily	Fluticasone 100 µg, twice daily
Overall Study STARTED	19	18
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ciclesonide n=19 Participants 160 µg, once daily	Fluticasone n=18 Participants 100 µg, twice daily	Total n=37 Participants Total of all reporting groups
Age, Continuous	39.61 years INTER_QUARTILE_RANGE 10.50 • n=5 Participants	46.02 years INTER_QUARTILE_RANGE 9.80 • n=7 Participants	42.25 years INTER_QUARTILE_RANGE 10.16 • n=5 Participants
Gender Female	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Gender Male	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 5 weeks

Population: The analyses on treatment effects were performed on all subjects who reached a PC20\<640mg/mL.

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

Outcome measures

Outcome measures
Measure	Ciclesonide n=11 Participants 160 µg, once daily	Fluticasone n=12 Participants 100 µg, twice daily
PC20 AMP (Post-treatment Compared to Baseline) Baseline PC20 large-particle AMP	3.7 Logarithm (mg/mL) Standard Deviation 2.6	3.0 Logarithm (mg/mL) Standard Deviation 2.4
PC20 AMP (Post-treatment Compared to Baseline) Baseline PC20 small-particle AMP	4.9 Logarithm (mg/mL) Standard Deviation 3.7	5.2 Logarithm (mg/mL) Standard Deviation 2.1
PC20 AMP (Post-treatment Compared to Baseline) Post-Treatment PC20 small-particle AMP	6.6 Logarithm (mg/mL) Standard Deviation 2.0	6.0 Logarithm (mg/mL) Standard Deviation 2.7
PC20 AMP (Post-treatment Compared to Baseline) Post-Treatment PC20 large-particle AMP	4.5 Logarithm (mg/mL) Standard Deviation 2.3	4.3 Logarithm (mg/mL) Standard Deviation 2.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks

Outcome measures

Outcome data not reported

Adverse Events

Ciclesonide

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Fluticasone

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ciclesonide n=19 participants at risk 160 µg, once daily	Fluticasone n=18 participants at risk 100 µg, twice daily
Skin and subcutaneous tissue disorders Urticaria	5.3% 1/19 • Number of events 1	0.00% 0/18
Infections and infestations Common cold	5.3% 1/19 • Number of events 1	0.00% 0/18
General disorders Pain armpit	0.00% 0/19	5.6% 1/18 • Number of events 1
Respiratory, thoracic and mediastinal disorders Inflammation of the throat	0.00% 0/19	5.6% 1/18 • Number of events 1

Additional Information

AstraZeneca Clinical Study Information Center

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60