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Clinical Trials/EUCTR2004-002983-80-AT
EUCTR2004-002983-80-AT
Active, not recruiting
Not Applicable

Comparison of the Efficacy of a Fixed Combination of Ciclesonide and Formoterol versus a Fixed Combination of Fluticasone and Salmeterol - EXCITED

ALTANA Pharma AG0 sites150 target enrollmentNovember 26, 2004
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
ALTANA Pharma AG
Enrollment
150
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 26, 2004
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Written informed consent
  • •\- Male or female outpatients
  • •\- Age 12 to 75 years
  • •\- History of bronchial asthma for at least 6 months
  • •\- Patients, who are in good health with the exception of asthma, and who have
  • •\- FEV1 \> 60% to \< 80% of predicted, when rescue medication has been withheld for at least 6 h before pulmonary function measurement. This applies to all eligible patients, either pre\-treated with a constant dose of \< or \= 500 µg fluticasone (or equivalent) per day only, or pre\-treated with a constant dose of \< or \= 250 µg fluticasone (or equivalent) per day in combination with:
  • •\-\- an inhaled long\-acting ß\-agonists (LABA) in a fixed or free combination, or
  • •\-\- sustained\-release theophylline, or
  • •\-\- a leukotriene antagonist, or
  • •\-\- a lipoxygenase inhibitor, or

Exclusion Criteria

  • •Diseases and health status:
  • •\- Clinically relevant abnormal laboratory values (e.g. abnormal serum potassium and glucose levels) suggesting an unknown disease and requiring further clinical evaluation,
  • •\- Concomitant severe diseases or diseases which are contraindications for the use of inhaled corticosteroids (ICS) (e.g. active and inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment), or contra\-indications for the use of long\-acting beta2\-agonists (LABAs, e.g. di\-agnosis or history of significant cardiovascular diseases, insulin\-dependent diabetes mellitus, uncontrolled hypertension, hyperthyroid\-ism, thyrotoxicosis, phaeochromocytoma, hypokalaemia, prolonged QTc interval (male \> 430ms, female \> 450ms) or tachyarrhythmia,
  • •\- Suffering from chronic obstructive pulmonary disease (COPD) (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function (e.g. infection of lower airways within 4 weeks prior to entry into the study),
  • •\- Current smoking or cessation of smoking within the last 6 months,
  • •\- Previous smoking with a smoking history \> or \= 10 cigarette pack\-years,
  • •\- More than one in\-patient hospitalization or emergency care visit due to asthma exacerbations in the past year before B0
  • •Medications:
  • •\- Use of injectable glucocorticosteroids or oral systemic glucocorticos\-teroids within 2 months prior to entry into the study, or more than 3 courses during the last 6 months,·
  • •\- Use of other drugs not allowed and washout times of prohibited drugs cannot be adhered to,

Outcomes

Primary Outcomes

Not specified

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