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CompletedNCT00728715Updated Aug 6, 2008

Efficacy of Budesonide-Formoterol in Bronchiectasis

An interventional study of budesonide-formoterol single inhaler and High dose of budesonide in Bronchiectasis, sponsored by Hospital General de Requena. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-08-06.

Sponsored by Hospital General de Requena · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bronchiectasis

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Keywords

  • Budesonide
  • Formoterol
  • Non cystic fibrosis bronchiectasis
03

In context

Bronchiectasis

373 studies on the registry are indexed under Bronchiectasis; 104 are open to participants now.

This study's planned enrollment of 40 is below the median of 59 across 238 interventional studies indexed under Bronchiectasis.

Browse Bronchiectasis studies →

Lead sponsor

Hospital General de Requena is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Asthma, COPD or current/past smnokers
  • No consent
  • Known intolerance to budesonide or formoterol
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    A

    Medium Dose of budesonide-formoterol

    Drug: budesonide-formoterol single inhaler · Drug: High dose of budesonide · Drug: A

  • Active comparator
    B

    High dose of inhaled budesonide (1600 mcg/day)

    Drug: budesonide-formoterol single inhaler · Drug: High dose of budesonide · Drug: B

Interventions

  • Drugbudesonide-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

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

  • DrugHigh dose of budesonide

    1600 mcg/d of budesonide

  • DrugA

    medium dose of budesonide-formoterol

  • DrugB

    High Dose Inhaled Budesonide

06

What researchers measure

Primary outcomes

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

    Time frame: at 3 and 6 months

Secondary outcomes

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

    Time frame: at 3 and 6 months

07

Study locations

1 site
  • Hospital General de Requena
    Valencia, Valencia 43260, Spain
08

References and documents

Publications

  • 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. PubMed 21778259 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2004, a primary completion of Jan 2005 and a completion of Jan 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2008
First posted
Aug 6, 2008
Start
Jan 2004
Primary completionActual
Jan 2005
CompletionActual
Jan 2005
Last update
Aug 6, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00728715
Lead sponsor
Hospital General de Requena
Collaborators
Esteve
First posted
Aug 6, 2008
Start date
Jan 2004
Primary completion
Jan 2005
Completion
Jan 2005
Last update
Aug 6, 2008

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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