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 |
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DOI | https://doi.org/10.1186/ISRCTN37115189 |
ClinicalTrials.gov number | NCT00306163 |
Secondary identifying numbers | BY9010/NL101 |
- Submission date
- 21/07/2006
- Registration date
- 21/07/2006
- Last edited
- 11/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof D.S. Postma
Scientific
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 |
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d.s.postma@int.umcg.nl |
Study information
Study design | Interventional treatment randomised double-blind active-control parallel assignment |
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Primary study design | Interventional |
Secondary study design | Randomised parallel trial |
Study setting(s) | Not specified |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Ciclesonide, fluticasone propionate |
Primary outcome measure | 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 study start date | 01/05/2006 |
Completion date | 01/01/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Sponsor information
Altana Pharma B.V. (The Netherlands)
Industry
Industry
Dr. A.M. van Horssen
P.O. Box 31
Hoofddorp
2130 AA
Netherlands
https://ror.org/00ycncb81 |
Funders
Funder type
Industry
Altana Pharma B.V. (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Basic results | No | No | |||
Results article | results | 01/03/2011 | 11/04/2019 | Yes | No |
Editorial Notes
11/04/2019: Publication reference added.
21/03/2016: added link to results - basic reporting.