Contact information
Type
Scientific
Primary contact
Prof D.S. Postma
ORCID ID
Contact details
University Medical Center Groningen (UMCG)
Department of Internal Medicine
Lung Diseases T3.260
P.O. Box 30.001
Groningen
9700 RB
Netherlands
+31 (0)50 3614934
d.s.postma@int.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00306163
Protocol/serial number
BY9010/NL101
Study information
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
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Interventional treatment randomised double-blind active-control parallel assignment
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Asthma
Intervention
Drug: Ciclesonide
Intervention type
Drug
Phase
Not Applicable
Drug names
Ciclesonide, fluticasone propionate
Primary outcome measures
PC20 (AMP) (Posttreatment compared to baseline).
Secondary outcome measures
1. Δ (Forced Vital Capacity [FVC]/Slow Vital Capacity [SVC]) at PC20 (AMP).
2. Safety and tolerability.
Overall trial start date
01/05/2006
Overall trial end date
01/01/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/05/2006
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands
Funders
Funder type
Industry
Funder name
Altana Pharma B.V. (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
See https://clinicaltrials.gov/ct2/show/results/NCT00306163
Publication summary