Efficacy of Budesonide-Formoterol in Bronchiectasis

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728715
• Other study ID #: HGR-0000013
• Status: Completed
• Phase: N/A
• First received: July 31, 2008
• Last updated: July 31, 2008
• Start date: January 2004
• Est. completion date: January 2005

Study information

• Verified date: July 2008
• Source: Hospital General de Requena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

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
• High dose of budesonide
1600 mcg/d of budesonide
• A
medium dose of budesonide-formoterol
• B
High Dose Inhaled Budesonide

Locations

Country	Name	City	State
Spain	Hospital General de Requena	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital General de Requena	Esteve Labs (Grant)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life (measured by St Gorge Respiratory Questionnaire)		at 3 and 6 months	Yes
Secondary	Forced spirometry; microbiological data, clinical data (dyspnea, cough, wheezes) and side effects		at 3 and 6 months	Yes