Condition category
Respiratory
Date applied
21/07/2006
Date assigned
21/07/2006
Last edited
21/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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) (Post–treatment 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

Sponsor information

Organisation

Altana Pharma B.V. (The Netherlands)

Sponsor details

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

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes

21/03/2016: added link to results - basic reporting.