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Efficacy of Budesonide-Formoterol in Bronchiectasis

This study has been completed.
Sponsor:
Collaborator:
Esteve Labs (Grant)
Information provided by:
Hospital General de Requena
ClinicalTrials.gov Identifier:
NCT00728715
First received: July 31, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted

July 31, 2008
July 31, 2008
January 2004
January 2005   (final data collection date for primary outcome measure)
Health related quality of life (measured by St Gorge Respiratory Questionnaire) [ Time Frame: at 3 and 6 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Forced spirometry; microbiological data, clinical data (dyspnea, cough, wheezes) and side effects [ Time Frame: at 3 and 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy of Budesonide-Formoterol in Bronchiectasis
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bronchiectasis
  • 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
  • Experimental: A
    Medium Dose of budesonide-formoterol
    Interventions:
    • Drug: budesonide-formoterol single inhaler
    • Drug: High dose of budesonide
    • Drug: A
  • Active Comparator: B
    High dose of inhaled budesonide (1600 mcg/day)
    Interventions:
    • Drug: budesonide-formoterol single inhaler
    • Drug: High dose of budesonide
    • Drug: B
Martínez-García MÁ, Soler-Cataluña JJ, Catalán-Serra P, Román-Sánchez P, Tordera MP. Clinical efficacy and safety of budesonide-formoterol in non-cystic fibrosis bronchiectasis. Chest. 2012 Feb;141(2):461-8. doi: 10.1378/chest.11-0180. Epub 2011 Jul 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2005
January 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00728715
HGR-0000013
No
Dr Miguel Angel Martínez-Garcia, Hospital General de Requena
Hospital General de Requena
Esteve Labs (Grant)
Not Provided
Hospital General de Requena
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP