Comparison of the Efficacy and Safety of 160 µg Ciclesonide Administered Once Daily in the Evening with or without Different Spacer Types in Patients with AsthmaA randomized, open-label, three-arm, parallel group study

• Conditions: asthma bronchial; MedDRA version: 8.0Level: lltClassification code 10003555

• Registration Number: EUCTR2005-002163-84-DE
• Lead Sponsor: ALTANA Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-06
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

· Male and female outpatients aged 12 to 75 years inclusive,
· written informed consent,
· history of persistent bronchial asthma (as defined by GINA 2004) for at least 6 months,
· good health with the exception of asthma,

· currently treated with
- either rescue medication only i.e. short-acting beta-agonists (either as monotherapy or as a fixed combination with an anticholinergic), or long-acting beta-agonists,
-or with inhaled steroids with a maximum daily dosage of 250 µg fluticasone propionate or equivalent
- or with other anti-inflammatory asthma drugs than inhaled steroids, i.e. leukotriene antagonists, xanthine derivates, inhaled cromones, lipoxygenase inhibitors,
- or with a fixed or concurrent combination of an inhaled steroid (up to 125µg/day FP or equivalent) and a long-acting ß-agonist or other asthma controllers

at a constant dose for the last 4 weeks directly prior to baseline.

· FEV1 must meet one of the following rules:
- either FEV1=61 - 90% of predicted in patients treated with rescue medication only,
- or FEV1=81 - 105% of predicted in patients treated with inhaled steroids alone or in combination with a long-acting ß-agonist or other asthma controller,
- or FEV1=61 - 105% in patients treated with other anti-inflammatory asthma drugs than inhaled steroids.

FEV1 and FVC have to be measured at least 4 hours after the last use of short-acting beta-agonists and fixed combinations of short-acting beta-agonists and anticholinergics and at least 24 hours after the last use of long-acting beta-agonists.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Diseases and health status:
· clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation,
· concomitant severe diseases or diseases which are contraindica-tions for the use of inhaled steroids (e. g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment),
· suffering from COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function,
· smoking history with = 10 cigarette pack-years (= 2 pipe pack-years)

Medication:
· use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months,
· treatment with inhaled steroids
- in dosages higher than listed in the inclusion criteria,
- or fluctuating doses of ICS
during the 4 weeks directly prior to baseline
· use of other drugs not allowed,
· washout times of drugs cannot be adhered to,
· known or suspected hypersensitivity to inhaled steroids or to the other excipients of the MDI,
· intolerance to salbutamol or to other excipients of the MDI,
· beginning of immunotherapy during the patient´s participation in the study, or having begun an immunotherapy less than three months prior to enrolment, or alternation in regimen of an immunotherapy during the study period.

Common criteria:
· pregnancy,
· intention to become pregnant during the course of the study,
· breast feeding,
· lack of safe contraception,
· participation in another study within the 30 days preceding and during the present study,
· previous enrolment into the current study,
· enrolment of the investigator, his/her family members, employees and other dependent persons,
· known or suspected non-compliance, alcohol or drug abuse,
· inability to follow the procedures of the study, e.g. due to lan-guage problems, psychological disorders,
· reversal of sleep pattern (e.g. night shift workers),
· intention to relocate during the course of the study, preventing adherence to visit schedule

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified