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Sponsors and Collaborators: |
Hospital General de Requena Esteve Labs (Grant) |
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Information provided by: | Hospital General de Requena |
ClinicalTrials.gov Identifier: | NCT00728715 |
Some studies have concluded that high-dose inhaled steroids (IS) are effective in the clinical control of patients with bronchiectasis, however the high doses needed provokes some adverse effects and lower doses are not effective. Combined treatment with budesonide and formoterol have demostrated to be effective in patients with asthma and COPD achieving the reduction of steroid dose thanks to the adition of a long-acting beta 2 agonists. There are no studies in the literature analysing the effect of combined treatment in patients with bronchiectasis. The objective of this study is to compare the efficacy and safety of formoterol-medium dose of budesonide in a single inhaler versus high-dose of budesonide in the clinical control of patientes with non-cystic fibrosis bronchiectasis.
Study Design:
Randomized (3 months) parallel groups study.
Patients:
Patients with bronchiectasis diagnosed by high-resolution CT scan and chronic obstructive airway obstruction.
Exclusion:
Asthma and current or past smokers.
Methods:
Run in period in all patients with high dose of budesonide (1600 mcg/day) for 3 months. After that, randomization into two groups: 1. The same treatment (1600 mcg/day of budesonide) or combined treatment with lower dose of budesonide (18 mcg/day of formoterol and 800 mcg of budesonide) in a single turbuhaler inhaler during 3 months.
Studied variables:
Clinical, functional, quality of life, microbiological and number of side effects.
Condition | Intervention |
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Bronchiectasis |
Drug: budesonide-formoterol single inhaler Drug: High dose of budesonide Drug: A Drug: B |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinical Efficacy and Safety of Budesonide and Formoterol in the Management of Non-Cystic Fibrosis Bronchiectasis |
Estimated Enrollment: | 40 |
Study Start Date: | January 2004 |
Study Completion Date: | January 2005 |
Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Medium Dose of budesonide-formoterol
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Drug: budesonide-formoterol single inhaler
High dose budesonide:Budesonide (Pulmocort turbuhaler) 400 mcg (2 inhalations bid) Medium dose budesonide plus formoterol (Rilast turbuhaler) 4,5 mcg of formoterol plus 400 mcg of budesonide: 2 inhalations bid
Drug: High dose of budesonide
1600 mcg/d of budesonide
Drug: A
medium dose of budesonide-formoterol
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B: Active Comparator
High dose of inhaled budesonide (1600 mcg/day)
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Drug: budesonide-formoterol single inhaler
High dose budesonide:Budesonide (Pulmocort turbuhaler) 400 mcg (2 inhalations bid) Medium dose budesonide plus formoterol (Rilast turbuhaler) 4,5 mcg of formoterol plus 400 mcg of budesonide: 2 inhalations bid
Drug: High dose of budesonide
1600 mcg/d of budesonide
Drug: B
High Dose Inhaled Budesonide
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No
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Hospital General de Requena ( Dr Miguel Angel Martínez-Garcia ) |
Study ID Numbers: | HGR-0000013, No |
Study First Received: | July 31, 2008 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00728715 |
Health Authority: | Spain: Ethics Committee |
Budesonide Formoterol Non cystic fibrosis bronchiectasis |
Symbicort Respiratory Tract Diseases Fibrosis |
Bronchiectasis Budesonide Formoterol |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic beta-Agonists Bronchial Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Anti-Asthmatic Agents Glucocorticoids Hormones Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |