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

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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Study Primary Completion Date: January 2005

Intervention(s) in this Clinical Trial

• 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
• Drug: B
  • High Dose Inhaled Budesonide

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Medium Dose of budesonide-formoterol
• Active Comparator: B
  • High dose of inhaled budesonide (1600 mcg/day)

Primary Measures

• Health related quality of life (measured by St Gorge Respiratory Questionnaire)
  • Time Frame: at 3 and 6 months
    Safety Issue?: Yes

Secondary Measures

• Forced spirometry; microbiological data, clinical data (dyspnea, cough, wheezes) and side effects
  • Time Frame: at 3 and 6 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hospital General de Requena

Information obtained from ClinicalTrials.gov on September 07, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00728715

Study ID Number: HGR-0000013

ClinicalTrials.gov Identifier: NCT00728715

Health Authority: Spain: Ethics Committee