ebulizer 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

Not Applicable

Completed

• Conditions: Asthma; Respiratory

• Registration Number: ISRCTN37115189
• Lead Sponsor: Altana Pharma B.V. (The Netherlands)

Brief Summary

2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/20595155 (added 11/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-21
• Study Completion: 2008-01-01
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PC20 (AMP) (Post?treatment compared to baseline).

Secondary Outcome Measures

Name	Time	Method
<br> 1. ? (Forced Vital Capacity [FVC]/Slow Vital Capacity [SVC]) at PC20 (AMP).<br> 2. Safety and tolerability.<br>