Nebulizer trial: evaluation of the influence of particle size of aerosolized adenosine 5'-monophosphate on bronchial responsiveness in patients with asthma and the effects of treatment with ciclesonide versus fluticasone

ISRCTN	ISRCTN37115189
DOI	https://doi.org/10.1186/ISRCTN37115189
ClinicalTrials.gov (NCT)	NCT00306163
Protocol serial number	BY9010/NL101
Sponsor	Altana Pharma B.V. (The Netherlands)
Funder	Altana Pharma B.V. (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof D.S. Postma
Scientific

University Medical Center Groningen (UMCG)
Department of Internal Medicine
Lung Diseases T3.260
P.O. Box 30.001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 3614934
Email	d.s.postma@int.umcg.nl

Primary study design	Interventional
Study design	Interventional treatment randomised double-blind active-control parallel assignment
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	Nebulizer trial: evaluation of the influence of particle size of aerosolized adenosine 5'-monophosphate on bronchial responsiveness in patients with asthma and the effects of treatment with ciclesonide versus fluticasone
Study objectives	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 (five weeks) and a treatment period (five weeks). The study will provide further data on safety and tolerability of ciclesonide.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Asthma
Intervention	Drug: Ciclesonide
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Ciclesonide, fluticasone propionate
Primary outcome measure(s)	PC20 (AMP) (Posttreatment compared to baseline).
Key secondary outcome measure(s)	1. Δ (Forced Vital Capacity [FVC]/Slow Vital Capacity [SVC]) at PC20 (AMP). 2. Safety and tolerability.
Completion date	01/01/2008

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
Key inclusion criteria	Main inclusion criteria: 1. History of bronchial asthma 2. Forced Expiratory Volume in once second (FEV1) more than 1.20 L 3. Positive skin prick test 4. Not more than 500 mcg/day fluticasone propionate or equivalent for at least 28 days prior to baseline visit
Key exclusion criteria	Main exclusion criteria: 1. Clinically relevant abnormal laboratory values 2. 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 3. Chronic Obstructive Pulmonary Disease (COPD) and /or other relevant lung diseases 4. One asthma exacerbation within two months or more than three exacerbations within the last year prior to baseline visit 5. Current smokers or ex-smokers with more than ten pack years, or having smoked within one year prior to baseline visit 6. Positive response to saline challenge at baseline visits 7. Positive bronchial hyperresponsiveness
Date of first enrolment	01/05/2006
Date of final enrolment	01/01/2008

University Medical Center Groningen (UMCG)

Groningen
9700 RB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2011	11/04/2019	Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

11/04/2019: Publication reference added.
21/03/2016: added link to results - basic reporting.