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 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

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

Study information

Study designInterventional treatment randomised double-blind active-control parallel assignment
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleNebulizer 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 objectivesThe 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) studiedAsthma
InterventionDrug: Ciclesonide
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Ciclesonide, fluticasone propionate
Primary outcome measurePC20 (AMP) (Post–treatment compared to baseline).
Secondary outcome measures1. Δ (Forced Vital Capacity [FVC]/Slow Vital Capacity [SVC]) at PC20 (AMP).
2. Safety and tolerability.
Overall study start date01/05/2006
Completion date01/01/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40
Key inclusion criteriaMain 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 criteriaMain 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 enrolment01/05/2006
Date of final enrolment01/01/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands

Sponsor information

Altana Pharma B.V. (The Netherlands)
Industry

Dr. A.M. van Horssen
P.O. Box 31
Hoofddorp
2130 AA
Netherlands

ROR logo "ROR" https://ror.org/00ycncb81

Funders

Funder type

Industry

Altana Pharma B.V. (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
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.