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Efficacy of Budesonide-Formoterol in Bronchiectasis

NCT ID: NCT00728715

Last Updated: 2008-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchiectasis

Keywords

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Budesonide Formoterol Non cystic fibrosis bronchiectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Medium Dose of budesonide-formoterol

Group Type EXPERIMENTAL

budesonide-formoterol single inhaler

Intervention Type DRUG

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

Intervention Type DRUG

1600 mcg/d of budesonide

A

Intervention Type DRUG

medium dose of budesonide-formoterol

B

High dose of inhaled budesonide (1600 mcg/day)

Group Type ACTIVE_COMPARATOR

budesonide-formoterol single inhaler

Intervention Type DRUG

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

Intervention Type DRUG

1600 mcg/d of budesonide

B

Intervention Type DRUG

High Dose Inhaled Budesonide

Interventions

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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

Intervention Type DRUG

High dose of budesonide

1600 mcg/d of budesonide

Intervention Type DRUG

A

medium dose of budesonide-formoterol

Intervention Type DRUG

B

High Dose Inhaled Budesonide

Intervention Type DRUG

Other Intervention Names

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B. High-dose budesonide arm A. Medium dose of budesonide plus formoterol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Esteve

OTHER

Sponsor Role collaborator

Hospital General de Requena

OTHER

Sponsor Role lead

Responsible Party

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Hospital General de Requena

Locations

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Hospital General de Requena

Valencia, Valencia, Spain

Site Status

Countries

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Spain

References

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Martinez-Garcia MA, Soler-Cataluna JJ, Catalan-Serra P, Roman-Sanchez P, Tordera MP. Clinical efficacy and safety of budesonide-formoterol in non-cystic fibrosis bronchiectasis. Chest. 2012 Feb;141(2):461-468. doi: 10.1378/chest.11-0180. Epub 2011 Jul 21.

Reference Type DERIVED
PMID: 21778259 (View on PubMed)

Other Identifiers

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HGR-0000013

Identifier Type: -

Identifier Source: org_study_id