AsthmaPhase 3Ach-ALNNCT01676987
Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma
A Phase 3 study testing Fixed combination of budesonide and formoterol and Budesonide in people with Asthma, run by Ache Laboratorios Farmaceuticos S.A..
Trial summary
To evaluate the efficacy and safety of a fixed-dose, single-capsule budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was Randomized, double-blind, multicenter, phase III, parallel clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 77 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fixed combination of budesonide and formoterol and Budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Jun 2011
- Phase
- Phase 3
- 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 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of uncontrolled asthma
- Age ranged from 18 to 77 years
- Nonsmokers
Who cannot join
- Use of oral corticosteroids, anti-leukotrienes, immunoglobulins, beta blockers, digitalis, amiodarone, antifungals, antidepressants, monoamine oxidase inhibitors and tricyclics during the standardization
- Atrial fibrillation, Flutter, severe and complex tachyarrhythmias atrioventricular block 1,2 and 3
- Diabetes mellitus
- Pregnancy
- Neuropsychiatric diseases
- Pulmonary malformations, tuberculosis, Cystic fibrosis
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- Immunosuppressive treatment
- Hospitalization for asthma or respiratory infection in last 30 days
- Severe systemic disease
About this study
Official title: Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma:a Randomized, Double-blind, Multicenter, Controlled Clinical Trial.
To evaluate the efficacy and safety of a fixed-dose, single-capsule budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was Randomized, double-blind, multicenter, phase III, parallel clinical trial.
Read the detailed description
the age of the patients ranged from 18 to 77 years. After a run-in period of 4 weeks, during which all of the patients received budesonide twice a day, they were randomized into one of the treatment groups for 12 weeks, twice a day.
The primary outcome measures were FEV1, FVC and morning PEF. We performed an intention-to-treat analysis of the data.
- Conditions
- Asthma
- Being tested
- Fixed combination of budesonide and formoterol, Budesonide
- Keywords
- Asthma, Budesonide, Adrenergic beta-2 receptor agonists.
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed combination of budesonide and formoterolDrug
Also called Group 1 (experimental): Budesonide and formoterol
Delivered dry powder inhaler for 12 weeks.
BudesonideDrug
Also called Group 2 (comparator): Budesonide
Delivered dry powder inhaler for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Fixed Combination of Budesonide and formoterol | Experimental | Group 1 (experimental): Fixed Combination of Budesonide and formoterol Receives: Drug: Fixed combination of budesonide and formoterol |
| Budesonide | Active comparator | Group 2 (comparator): Budesonide Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma
the primary outcome Measures were FEV1(forced expiratory volume in one second), FVC(forced vital capacity)and morning PEF (peak expiratory flow).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startApr 2009
- Primary completionSep 2010
- Study completionJun 2011
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 AsthmaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emílio Pizzichini, Principal investigator, NUPAIVA Asthma Research Center, UFSC- Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676987
- Sponsor's protocol ID
- Ach-ALN-04(7/07)
- Acronym
- Ach-ALN
- Status last verified
- Aug 2012
- First submitted
- 29 Aug 2012
- Last updated
- 31 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stirbulov R, Fritscher CC, Pizzichini E, Pizzichini MM. Evaluation of the efficacy and safety of a fixed-dose, single-capsule budesonide-formoterol combination in uncontrolled asthma: a randomized, double-blind, multicenter, controlled clinical trial. J Bras Pneumol. 2012 Jul-Aug;38(4):431-7. doi: 10.1590/s1806-37132012000400004. English, Portuguese.
PubMed 22964926
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma:a Randomized, Double-blind, Multicenter, Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT01676987
- Acronym / sponsor ID
- Ach-ALN / Ach-ALN-04(7/07)
- Conditions
- Asthma
- Keywords
- Asthma, Budesonide, Adrenergic beta-2 receptor agonists.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 31 Aug 2012 (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.
To evaluate the efficacy and safety of a fixed-dose, single-capsule budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was Randomized, double-blind, multicenter, phase III, parallel clinical trial.
Detailed description
the age of the patients ranged from 18 to 77 years. After a run-in period of 4 weeks, during which all of the patients received budesonide twice a day, they were randomized into one of the treatment groups for 12 weeks, twice a day.
The primary outcome measures were FEV1, FVC and morning PEF. We performed an intention-to-treat analysis of the data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed Combination of Budesonide and formoterol | Experimental | Drug: Fixed combination of budesonide and formoterolGroup 1 (experimental): Fixed Combination of Budesonide and formoterol |
| Budesonide | Active comparator | Drug: BudesonideGroup 2 (comparator): Budesonide |
Who may qualify
- Ages
- 18 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of uncontrolled asthma
- Age ranged from 18 to 77 years
- Nonsmokers
Key exclusion criteria (9 listed)
- Use of oral corticosteroids, anti-leukotrienes, immunoglobulins, beta blockers, digitalis, amiodarone, antifungals, antidepressants, monoamine oxidase inhibitors and tricyclics during the standardization
- Atrial fibrillation, Flutter, severe and complex tachyarrhythmias atrioventricular block 1,2 and 3
- Diabetes mellitus
- Pregnancy
- Neuropsychiatric diseases
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 |
|---|---|---|
| Fixed combination of budesonide and formoterolAlso: Group 1 (experimental): Budesonide and formoterolDelivered dry powder inhaler for 12 weeks. | Drug | Fixed Combination of Budesonide and formoterol |
| BudesonideAlso: Group 2 (comparator): BudesonideDelivered dry powder inhaler for 12 weeks. | Drug | Budesonide |
Primary outcome
Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma
Time frame: 12 weeks
the primary outcome Measures were FEV1(forced expiratory volume in one second), FVC(forced vital capacity)and morning PEF (peak expiratory flow).
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 31 Aug 2012.
- Derived from this study: PubMed 22964926Stirbulov R, Fritscher CC, Pizzichini E, Pizzichini MM. Evaluation of the efficacy and safety of a fixed-dose, single-capsule budesonide-formoterol combination in uncontrolled asthma: a randomized, double-blind, multicenter, controlled clinical trial. J Bras Pneumol. 2012 Jul-Aug;38(4):431-7. doi: 10.1590/s1806-37132012000400004. English, Portuguese.
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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.
Emílio Pizzichini principal investigator
NUPAIVA Asthma Research Center, UFSC- Brazil
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fixed combination of budesonide and formoterol and Budesonide in people with Asthma, run by Ache Laboratorios Farmaceuticos S.A..
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 3 inclusion and 9 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 31 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma (time frame: 12 weeks). 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 NCT01676987, 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 31 Aug 2012.