ASTHMAPhase 4NCT01089322
Risk Factors Associated to Difficult-to-control Asthma
A Phase 4 study testing inhaled corticosteroid plus LABA plus oral corticosteroid in people with ASTHMA, run by Rafael Stelmach at 1 site in Brazil.
Trial summary
Several studies have demonstrated the efficacy of asthma treatment but despite being correctly diagnosed, conveniently prescribed and adherent to the therapeutics, 5% to 10% of asthmatics do not reach disease control. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ASTHMA
- What is being tested?
- inhaled corticosteroid plus LABA plus oral corticosteroid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Dec 2005to 13 May 2009
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Diagnosis of moderate to severe asthma (GINA) for at least one year
- Presence of airway obstruction reversibility (documented within the last 5 years before the start-up of study)
- Smoking, non-smoking or ex-smoking patients of <30 pack-years.
- Need of inhaled corticosteroid (IC),> or equal 1000mcg of Beclomethasone Dipropionate (DPB) or similar in the last year plus beta 2 long duration agonist in the last year.
- At least one exacerbation with the need of oral corticosteroid in the last year.
Who cannot join
- Pregnant women;
- Co-morbidities that may interfere with the management of the study;
- Patients who cannot understand the procedures of the study or who are not able to provide their free and clarified consent;
- Patients with other pulmonary diseases which may interfere with the evaluation of the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo - Heart Institute and Hospital das Clínicas
São Paulo, São Paulo
About this study
Official title: Risk Factors Associated to Difficult-to-control Asthma: Characterization of Clinical, Structural and Inflammatory Factors Related to Treatment Response
Several studies have demonstrated the efficacy of asthma treatment but despite being correctly diagnosed, conveniently prescribed and adherent to the therapeutics, 5% to 10% of asthmatics do not reach disease control.
The aim of this study is to measure asthma control, evaluate inflammatory and functional characteristics, describe comorbidities and aggravating factors and phenotypes derived from the characteristics of a severe asthmatic population followed at an outpatient university service in Sao Paolo, Brazil.
Read the detailed description
Study design: interventional
Patients selection:
Seventy-four severe asthma patients, aged between 18 and 65 years old were recruited from the outpatient clinics of the Pulmonary Division of the University of São Paolo Hospital.
Severe asthma were defined according to GINA. Intervention: after 2 weeks screening period patients were treated with high inhaled corticosteroid dose plus long acting beta 2 agonist during 12 weeks plus oral corticosteroid ( prednisone 40 mg/day) during 2 weeks.
Procedures ( baseline, after 2 weeks and 12 weeks): asthma control questionnaire (ACQ), asthma control (ACT) test, lung function test, quality of life questionnaire (SGRQ and SF-36), exhaled nitric oxide (FeNO), induced sputum (IS). After 12 weeks patients underwent the following evaluation: Upper Digestive Endoscopy, Esophageal 24hs pHmetry, High Resolution Chest Tomography, Nasoscope exam,Bronchofibroscopy with endobronchial biopsy.
- Conditions
- ASTHMA
- Being tested
- inhaled corticosteroid plus LABA plus oral corticosteroid
- Keywords
- SEVERE ASTHMA, RISK FACTORS, CHARACTERIZATION, CLINICAL CONTROL, INFLAMMATORY MARKERS, SEVERE, CONTROL
- Medical subject headings
- Asthma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled corticosteroid plus LABA plus oral corticosteroidDrug
Also called inhaled corticosteroid, LABA, oral corticosteroid
formoterol plus budesonide 12/400mcg 2times/day and 6/200 mcg as needed and prednisone 40 mcg
| Study group | Role | What they receive |
|---|---|---|
| Stantardized treament | Experimental | oral and inhaled corticosteroid plus LABA Receives: Drug: inhaled corticosteroid plus LABA plus oral corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control questionnaire (ACQ)
Compare ACQ score in baseline and after 2 weeks of oral plus inhaled corticosteroid plus LABA and after 12 weeks of inhaled corticosteroid plus LABA
Measured: Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA
Secondary outcomes (1)
Inflammatory parameters
Compare inflammatory parameters ( FeNO and Induced sputum) at baseline and after 2 weeks of oral plus inhaled corticosteroid plus LABA and after 12 weeks of inhaled corticosteroid plus LABA treatment
Measured: Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study start9 Dec 2005
- Primary completion3 Apr 2009
- Study completion13 May 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Retrospective analysis after treatment outcome (controlled vs. non controlled) based on the primary outcome; and post hoc analysis after oral steroid treatment based on pulmonary function reversibility
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rafael Stelmach
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor-investigator, Rafael Stelmach, University of Sao Paulo General Hospital
- Investigators
- Regina M. Carvalho Pinto, MD, Principal investigator, University of Sao PauloRafael Stelmach, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089322
- Sponsor's protocol ID
- OBSTRUÇÃOHC-02
- Status last verified
- Feb 2017
- First submitted
- 22 Feb 2010
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Athanazio R, Carvalho-Pinto R, Fernandes FL, Rached S, Rabe K, Cukier A, Stelmach R. Can severe asthmatic patients achieve asthma control? A systematic approach in patients with difficult to control asthma followed in a specialized clinic. BMC Pulm Med. 2016 Nov 16;16(1):153. doi: 10.1186/s12890-016-0314-1.
PubMed 27852260de Carvalho-Pinto RM, Cukier A, Angelini L, Antonangelo L, Mauad T, Dolhnikoff M, Rabe KF, Stelmach R. Clinical characteristics and possible phenotypes of an adult severe asthma population. Respir Med. 2012 Jan;106(1):47-56. doi: 10.1016/j.rmed.2011.08.013. Epub 2011 Sep 3.
PubMed 21890336
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Associated to Difficult-to-control Asthma: Characterization of Clinical, Structural and Inflammatory Factors Related to Treatment Response
- ClinicalTrials.gov ID
- NCT01089322
- Acronym / sponsor ID
- OBSTRUÇÃOHC-02
- Conditions
- ASTHMA
- Keywords
- SEVERE ASTHMA, RISK FACTORS, CHARACTERIZATION, CLINICAL CONTROL, INFLAMMATORY MARKERS, SEVERE, CONTROL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Rafael StelmachUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 9 Dec 2005 (actual)
- Primary completion
- 3 Apr 2009 (actual)
- Study completion
- 13 May 2009 (actual)
- First posted
- 18 Mar 2010 (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.
Several studies have demonstrated the efficacy of asthma treatment but despite being correctly diagnosed, conveniently prescribed and adherent to the therapeutics, 5% to 10% of asthmatics do not reach disease control.
The aim of this study is to measure asthma control, evaluate inflammatory and functional characteristics, describe comorbidities and aggravating factors and phenotypes derived from the characteristics of a severe asthmatic population followed at an outpatient university service in Sao Paolo, Brazil.
Detailed description
Study design: interventional
Patients selection:
Seventy-four severe asthma patients, aged between 18 and 65 years old were recruited from the outpatient clinics of the Pulmonary Division of the University of São Paolo Hospital.
Severe asthma were defined according to GINA. Intervention: after 2 weeks screening period patients were treated with high inhaled corticosteroid dose plus long acting beta 2 agonist during 12 weeks plus oral corticosteroid ( prednisone 40 mg/day) during 2 weeks.
Procedures ( baseline, after 2 weeks and 12 weeks): asthma control questionnaire (ACQ), asthma control (ACT) test, lung function test, quality of life questionnaire (SGRQ and SF-36), exhaled nitric oxide (FeNO), induced sputum (IS). After 12 weeks patients underwent the following evaluation: Upper Digestive Endoscopy, Esophageal 24hs pHmetry, High Resolution Chest Tomography, Nasoscope exam,Bronchofibroscopy with endobronchial biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Retrospective analysis after treatment outcome (controlled vs. non controlled) based on the primary outcome; and post hoc analysis after oral steroid treatment based on pulmonary function reversibility
| Arm | Type | Receives |
|---|---|---|
| Stantardized treament | Experimental | Drug: inhaled corticosteroid plus LABA plus oral corticosteroidoral and inhaled corticosteroid plus LABA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 65 years
- Diagnosis of moderate to severe asthma (GINA) for at least one year
- Presence of airway obstruction reversibility (documented within the last 5 years before the start-up of study)
- Smoking, non-smoking or ex-smoking patients of <30 pack-years.
- Need of inhaled corticosteroid (IC),> or equal 1000mcg of Beclomethasone Dipropionate (DPB) or similar in the last year plus beta 2 long duration agonist in the last year.
Key exclusion criteria (4 listed)
- Pregnant women;
- Co-morbidities that may interfere with the management of the study;
- Patients who cannot understand the procedures of the study or who are not able to provide their free and clarified consent;
- Patients with other pulmonary diseases which may interfere with the evaluation of the study.
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 |
|---|---|---|
| inhaled corticosteroid plus LABA plus oral corticosteroidAlso: inhaled corticosteroid, LABA, oral corticosteroidformoterol plus budesonide 12/400mcg 2times/day and 6/200 mcg as needed and prednisone 40 mcg | Drug | Stantardized treament |
Primary outcome
Asthma control questionnaire (ACQ)
Time frame: Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA
Compare ACQ score in baseline and after 2 weeks of oral plus inhaled corticosteroid plus LABA and after 12 weeks of inhaled corticosteroid plus LABA
1 secondary outcome
Inflammatory parameters
Time frame: Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA
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 16 Feb 2017.
- Derived from this study: PubMed 27852260Athanazio R, Carvalho-Pinto R, Fernandes FL, Rached S, Rabe K, Cukier A, Stelmach R. Can severe asthmatic patients achieve asthma control? A systematic approach in patients with difficult to control asthma followed in a specialized clinic. BMC Pulm Med. 2016 Nov 16;16(1):153. doi: 10.1186/s12890-016-0314-1.
- Derived from this study: PubMed 21890336de Carvalho-Pinto RM, Cukier A, Angelini L, Antonangelo L, Mauad T, Dolhnikoff M, Rabe KF, Stelmach R. Clinical characteristics and possible phenotypes of an adult severe asthma population. Respir Med. 2012 Jan;106(1):47-56. doi: 10.1016/j.rmed.2011.08.013. Epub 2011 Sep 3.
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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.
Regina M. Carvalho Pinto, MD principal investigator
University of Sao Paulo
Rafael Stelmach, PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing inhaled corticosteroid plus LABA plus oral corticosteroid in people with ASTHMA, run by Rafael Stelmach at 1 site in Brazil.
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 6 inclusion and 4 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 16 Feb 2017. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Asthma control questionnaire (ACQ) (time frame: Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA). 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 NCT01089322, which also lists 2 linked publications.
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 16 Feb 2017.