Efficacy of Budesonide-Formoterol in Bronchiectasis

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Efficacy and Safety of Budesonide and Formoterol in the Management of Non-Cystic Fibrosis Bronchiectasis

Conditions
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Bronchiectasis

Intervention / Treatment
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* Drug: budesonide-formoterol single inhaler
* Drug: High dose of budesonide
* Drug: A
* Drug: B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years old patients diagnosed of non-cystic fibrosis bronchiectasis More than 1 pulmonary lobe affected Chronic obstructive airflow obstruction Stable phase of the disease Exclusion Criteria: Asthma, COPD or current/past smnokers No consent Known intolerance to budesonide or formoterol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Medium Dose of budesonide-formoterol | Drug: budesonide-formoterol single inhaler<br>* 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<br>* Other names: A. Medium dose of budesonide plus formoterol;Drug: High dose of budesonide<br>* 1600 mcg/d of budesonide<br>Drug: A<br>* medium dose of budesonide-formoterol<br>|
| Active Comparator: B<br>High dose of inhaled budesonide (1600 mcg/day) | Drug: budesonide-formoterol single inhaler<br>* 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<br>* Other names: A. Medium dose of budesonide plus formoterol;Drug: High dose of budesonide<br>* 1600 mcg/d of budesonide<br>Drug: B<br>* High Dose Inhaled Budesonide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life (measured by St Gorge Respiratory Questionnaire) |  | at 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced spirometry; microbiological data, clinical data (dyspnea, cough, wheezes) and side effects |  | at 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Budesonide, Formoterol, Non cystic fibrosis bronchiectasis