NCT00728715

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
Last Updated

August 6, 2008

Status Verified

July 1, 2008

Enrollment Period

1 year

First QC Date

July 31, 2008

Last Update Submit

July 31, 2008

Conditions

Bronchiectasis

Keywords

BudesonideFormoterolNon cystic fibrosis bronchiectasis

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life (measured by St Gorge Respiratory Questionnaire)

    at 3 and 6 months

Secondary Outcomes (1)

  • Forced spirometry; microbiological data, clinical data (dyspnea, cough, wheezes) and side effects

    at 3 and 6 months

Study Arms (2)

A

EXPERIMENTAL

Medium Dose of budesonide-formoterol

Drug: budesonide-formoterol single inhalerDrug: High dose of budesonideDrug: A

B

ACTIVE COMPARATOR

High dose of inhaled budesonide (1600 mcg/day)

Drug: budesonide-formoterol single inhalerDrug: High dose of budesonideDrug: B

Interventions

budesonide-formoterol single inhalerDRUG

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

Also known as: B. High-dose budesonide arm, A. Medium dose of budesonide plus formoterol
AB
High dose of budesonideDRUG

1600 mcg/d of budesonide

AB
ADRUG

medium dose of budesonide-formoterol

A
BDRUG

High Dose Inhaled Budesonide

B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old patients diagnosed of non-cystic fibrosis bronchiectasis
  • More than 1 pulmonary lobe affected
  • Chronic obstructive airflow obstruction
  • Stable phase of the disease

You may not qualify if:

  • Asthma, COPD or current/past smnokers
  • No consent
  • Known intolerance to budesonide or formoterol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General de Requena

Valencia, Valencia, 43260, Spain

Location

Related Publications (1)

  • 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.

    PMID: 21778259DERIVED

MeSH Terms

Conditions

Bronchiectasis

Interventions

Formoterol FumarateBudesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 6, 2008

Study Start

January 1, 2004

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

August 6, 2008

Record last verified: 2008-07

Locations

ES(1)