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
  Purpose

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
Bronchiectasis
Drug: budesonide-formoterol single inhaler
Drug: High dose of budesonide
Drug: A
Drug: B

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Efficacy and Safety of Budesonide and Formoterol in the Management of Non-Cystic Fibrosis Bronchiectasis

Resource links provided by NLM:


Further study details as provided by Hospital General de Requena:

Primary Outcome Measures:
  • Health related quality of life (measured by St Gorge Respiratory Questionnaire) [ Time Frame: at 3 and 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Forced spirometry; microbiological data, clinical data (dyspnea, cough, wheezes) and side effects [ Time Frame: at 3 and 6 months ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728715

Locations
Spain
Hospital General de Requena
Valencia, Spain, 43260
Sponsors and Collaborators
Hospital General de Requena
Esteve Labs (Grant)
  More Information

No publications provided by Hospital General de Requena

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Miguel Angel Martínez-Garcia, Hospital General de Requena
ClinicalTrials.gov Identifier: NCT00728715     History of Changes
Other Study ID Numbers: HGR-0000013
Study First Received: July 31, 2008
Last Updated: July 31, 2008
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital General de Requena:
Budesonide
Formoterol
Non cystic fibrosis bronchiectasis

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Formoterol
Budesonide
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014