Trial | NCT00728715  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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 Started
Jan 31
2004
Primary Completion
Jan 31
2005
Study Completion
Jan 31
2005
Last Update
Aug 06
2008
Estimate

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

  • Other names: B. High-dose budesonide arm, A. Medium dose of budesonide plus formoterol

Drug High dose of budesonide

1600 mcg/d of budesonide

Drug A

medium dose of budesonide-formoterol

Drug B

High Dose Inhaled Budesonide

A Experimental

Medium Dose of budesonide-formoterol

B Active Comparator

High dose of inhaled budesonide (1600 mcg/day)

Criteria 

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
No Results Posted