BronchiectasisNCT00728715
Efficacy of Budesonide-Formoterol in Bronchiectasis
A study testing budesonide-formoterol single inhaler, High dose of budesonide and A in people with Bronchiectasis, run by Hospital General de Requena at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- budesonide-formoterol single inhaler, High dose of budesonide and A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2004to Jan 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Asthma, COPD or current/past smnokers
- No consent
- Known intolerance to budesonide or formoterol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy and Safety of Budesonide and Formoterol in the Management of Non-Cystic Fibrosis Bronchiectasis
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:
Read more
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.
- Conditions
- Bronchiectasis
- Being tested
- budesonide-formoterol single inhaler, High dose of budesonide, A, B
- Keywords
- Budesonide, Formoterol, Non cystic fibrosis bronchiectasis
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonide-formoterol single inhalerDrug
Also called B. High-dose budesonide arm, A. Medium dose of budesonide plus formoterol
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 budesonideDrug
1600 mcg/d of budesonide
ADrug
medium dose of budesonide-formoterol
BDrug
High Dose Inhaled Budesonide
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Medium Dose of budesonide-formoterol Receives: Drug: budesonide-formoterol single inhaler; Drug: High dose of budesonide; Drug: A |
| B | Active comparator | High dose of inhaled budesonide (1600 mcg/day) Receives: Drug: budesonide-formoterol single inhaler; Drug: High dose of budesonide; Drug: B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life (measured by St Gorge Respiratory Questionnaire)
Measured: at 3 and 6 months
Secondary outcomes (1)
Forced spirometry; microbiological data, clinical data (dyspnea, cough, wheezes) and side effects
Measured: at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2008 (estimated)
- Study startJan 2004
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de Requena
- Sponsor type
- University, hospital or other
- Collaborators
- Esteve
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728715
- Sponsor's protocol ID
- HGR-0000013
- Status last verified
- Jul 2008
- First submitted
- 31 Jul 2008
- Last updated
- 6 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Budesonide and Formoterol in the Management of Non-Cystic Fibrosis Bronchiectasis
- ClinicalTrials.gov ID
- NCT00728715
- Acronym / sponsor ID
- HGR-0000013
- Conditions
- Bronchiectasis
- Keywords
- Budesonide, Formoterol, Non cystic fibrosis bronchiectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital General de RequenaUniversity, hospital or other
- Collaborators
- Esteve
- Study start
- Jan 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 6 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: budesonide-formoterol single inhaler, Drug: High dose of budesonide, Drug: AMedium Dose of budesonide-formoterol |
| B | Active comparator | Drug: budesonide-formoterol single inhaler, Drug: High dose of budesonide, Drug: BHigh dose of inhaled budesonide (1600 mcg/day) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Asthma, COPD or current/past smnokers
- No consent
- Known intolerance to budesonide or formoterol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| budesonide-formoterol single inhalerAlso: B. High-dose budesonide arm, A. Medium dose of budesonide plus formoterolHigh 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 | Drug | A, B |
| High dose of budesonide1600 mcg/d of budesonide | Drug | A, B |
| Amedium dose of budesonide-formoterol | Drug | A |
| BHigh Dose Inhaled Budesonide | Drug | B |
Primary outcome
Health related quality of life (measured by St Gorge Respiratory Questionnaire)
Time frame: at 3 and 6 months
1 secondary outcome
Forced spirometry; microbiological data, clinical data (dyspnea, cough, wheezes) and side effects
Time frame: at 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2008.
- Derived from this study: PubMed 21778259Martinez-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.
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing budesonide-formoterol single inhaler, High dose of budesonide and A in people with Bronchiectasis, run by Hospital General de Requena at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (measured by St Gorge Respiratory Questionnaire) (time frame: at 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00728715, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2008.