AsthmaNOTOSNCT04835961
AdditioN of Fixed Dose Combination (FDC) Of Budesonide/Formoterol Via Elpenhaler® Device in Greek Patients With asThma accΟrding to Standard Clinical Practice.
An observational study of Asthma, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
Trial summary
The budesonide / formoterol combination can be used both as a maintenance treatment and as a maintenance and relief therapy (MART) where in the latter there is also anti-inflammatory action in contrast to the use of SABA. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Maintenace and As needed
- How many people
- 1,037 participants
- Where
- 1 siteGreece
- Study dates
- 1 May 2021to 1 Jul 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients proflle is based on GINA 2020 guidelines that recommend, among other things, the symptom-driven use of inhaled corticosteroids / long-acting β2-stimulants (ICS / LABA) (as needed). This study will record the use of budesonide / formoterol either as maintenance treatment or / or as needed according to standard clinical practice and at the discretion of the treating physician.
Who may be able to join
- Adult patients Newly diagnosed patients with asthma without prior treatment or receiving previous low dose (LD) ICS / LABA treatment, as needed.
- Patients who are not adequately controlled with LD ICS as maintenance therapy and need to have LABA added:
- or as a maintenance treatment
- either as maintenance therapy and as an invocation to treat the symptoms.
- Patients who are not adequately controlled with LD or moderate (MD) ICS and LABA doses and need to have ICS / LABA added as an adjunctive therapy to treat the symptoms.
- Consent and compliance with the therapies and study procedures.
Who cannot join
- Patients <18
- Patients with COPD
- Patients with ACO
Trial locations and contacts
1 site in 1 country.
About this study
Official title: This Study Will Record the Use of Budesonide / Formoterol Either as Maintenance Treatment or / or as Needed According to Standard Clinical Practice and at the Discretion of the Treating Physician.
The budesonide / formoterol combination can be used both as a maintenance treatment and as a maintenance and relief therapy (MART) where in the latter there is also anti-inflammatory action in contrast to the use of SABA. This anti-inflammatory and soothing effect has been recognized by the Global Initiatives for Asthma (GINA) guidelines and is recommended as a palliative treatment for all types of asthma severity versus Short Acting Beta Agonists (SABA).
Test results have shown that the invoked budesonide / formoterol combination therapy had a similar (not lower) effect on the annual exacerbation rate, with lower exposure to ICS compared to regular maintenance therapy with inhaled corticosteroids (ICS), although budesonide / formoterol therapy appeared to was inferior to ongoing asthma control. Another study showed no inferiority of the stable budesonide / formoterol combination compared to maintenance ICS plus the required SABA dosing regimen in reducing the annual severe exacerbation rate in patients with mild asthma.
Read more
Patients receiving budesonide / formoterol as adjunctive therapy or as maintenance therapy experienced a reduced incidence of exacerbations including asthma-related SAEs, compared with patients receiving long acting beta agonists (LABAs) or SABAs as sedatives, ICS or ICS / LA terbutaline or salbutamol. Studies have shown that patients spent more days without palliative care, indicating a significant reduction in reliance on palliative care while improving both disease control and daily functioning and well-being. Asthma symptoms and nocturnal awakening were significantly reduced, and FEV1 levels before and after treatment showed significant improvement in lung function and quality of life as shown by the AQLQ-S questionnaire score. In addition, ICS / LABA therapy as a palliative or maintenance treatment appears to be well tolerated and reduces the risk of severe exacerbations following exposure to high doses of SABA which may mask the worsening of inflammation.
The meta-analysis of Rogliani et. al. showed that low dose (LD) to medium dose (MD) ICS / LABA MART was as effective as HD ICS / LABA and SABA as needed treatments in reducing the risk of severe asthma exacerbations and that MART was generally more effective than low dose LD ICS / LABA + as needed LABA or SABA, or ICS / LABA as needed or ICS + as needed SABA treatments. The efficacy of ICS / LABA as needed treatment in the risk of severe exacerbation was significantly higher than ICS + as needed SABA treatment but not ICS / LABA + as needed SABA in patients with mild to severe asthma. LD to MD MART and HD ICS / LABA + as needed SABA were equally effective (P> 0.05) in improving PEF, and more effective (P <0.05) than LD ICS / LABA + as needed SABA or LABA, ICS / LABA as needed, ICS + SABA as needed, and SABA as needed. Administration of ICS / LABA as purely invasive use significantly improved (P <0.05) PEF compared to ICS + SABA as needed, LD ICS / LABA + SABA as needed, and SABA as needed treatments. MART improved lung function and disease control compared to other invasive therapies in patients with moderate asthma. In contrast, in patients with moderate to severe asthma, LD to MD MART was partially more effective than other invasive therapies in improving lung function and controlling asthma. No differences were found in the safety profile which was measured as the risk of occurrence of YOU.
The combination of budesonide / formoterol as maintenance therapy and as-needed palliative care could improve overall asthma control without the need for additional palliative care.
Read the detailed description
Pulmoton® is an inhaled combination of budesonide and formoterol fumarate dihydrate in doses of 100 / 6mcg, 200 / 6mcg, 400/12 mcg, administered by Elpenhaler®, a powder inhaler developed in doses developed by the ELPEN. It has been approved as a bronchodilator in the treatment of asthma where combination therapy (ICS / LABA) is appropriate in patients who are not adequately controlled with inhaled corticosteroids and rely on short-acting inhaled β2-stimulants or in patients already satisfactorily controlled with both corticosteroids. long-acting β2-stimulants.
Pulmoton® is not recommended for the initial treatment of asthma. The dosage of the individual components of Pulmoton® is separate and must be adjusted according to the severity of the condition. This should be taken into account, not only when starting treatment with stable combination products, but also when adjusting the maintenance dosage.
The dose should be adjusted to the lowest possible, by which effective control of symptoms is achieved and maintained. Patients should be re-evaluated regularly by their physician so that the dose of Pulmoton® they receive remains the best possible. When long-term control of symptoms is achieved with the lowest recommended dose, then in the next step only the inhaled corticosteroid can be tested.
There are two alternatives to treating asthma with Pulmoton®:
- Pulmoton® Maintenance Therapy: Pulmoton® is taken as a regular maintenance treatment along with a separate rapid-acting bronchodilator to relieve symptoms.
- Pulmoton® Maintenance and Relief Therapy: Pulmoton® is also taken as regular maintenance and invocative treatment for symptoms.
Further information on the efficacy and safety of the drug under study can be found in the Product Characteristics Summary (SmPC).
Aims of the study The GINA 2020 guidelines recommend, among other things, the symptom-driven use of ICS / LABA (as needed).
This study will record the use of budesonide / formoterol either as maintenance treatment or / or as needed according to standard clinical practice and at the discretion of the treating physician.
- Conditions
- Asthma
- Being tested
- Maintenace and As needed
- Keywords
- asthma, as needed treatment, maintenance treatment
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintenace and As neededOther
This study will record the use of budesonide / formoterol either as maintenance treatment or / or as needed according to standard clinical practice and at the discretion of the treating physician.
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control
Asthma control at 3 and 6 months of treatment.
Measured: 6 months
Secondary outcomes (3)
FEV1
The evaluation of pulmonary function at 3 and 6 months of treatment.
Measured: 6 months
MiniAQLQ questionnaire
The evaluation of Quality of Life at 3 and 6 months of treatment.
Measured: 6 months
FSI-10 questionnaire
Assessing patient satisfaction with the use of the inhalation device
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 May 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,037 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835961
- Sponsor's protocol ID
- 2020-BUDFOR-EL-127
- Acronym
- NOTOS
- Status last verified
- Oct 2023
- First submitted
- 2 Apr 2021
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Husseini ZW, Gosens R, Dekker F, Koppelman GH. The genetics of asthma and the promise of genomics-guided drug target discovery. Lancet Respir Med. 2020 Oct;8(10):1045-1056. doi: 10.1016/S2213-2600(20)30363-5. Epub 2020 Sep 7.
PubMed 329108991. Global Initiative for Asthma. Gglobal Strategy for Asthma Management and Prevention. (2020) Available from: www.ginasthma.org
Jenkins CR, Bateman ED, Sears MR, O'Byrne PM. What have we learnt about asthma control from trials of budesonide/formoterol as maintenance and reliever? Respirology. 2020 Aug;25(8):804-815. doi: 10.1111/resp.13804. Epub 2020 Mar 31.
PubMed 32237004Lougheed MD, Lemiere C, Ducharme FM, Licskai C, Dell SD, Rowe BH, Fitzgerald M, Leigh R, Watson W, Boulet LP; Canadian Thoracic Society Asthma Clinical Assembly. Canadian Thoracic Society 2012 guideline update: diagnosis and management of asthma in preschoolers, children and adults. Can Respir J. 2012 Mar-Apr;19(2):127-64. doi: 10.1155/2012/635624.
PubMed 22536582Kaplan AG, Balter MS, Bell AD, Kim H, McIvor RA. Diagnosis of asthma in adults. CMAJ. 2009 Nov 10;181(10):E210-20. doi: 10.1503/cmaj.080006. Epub 2009 Sep 21. No abstract available.
PubMed 19770241Lemanske RF Jr, Busse WW. Asthma: clinical expression and molecular mechanisms. J Allergy Clin Immunol. 2010 Feb;125(2 Suppl 2):S95-102. doi: 10.1016/j.jaci.2009.10.047.
PubMed 20176271Bai TR, Vonk JM, Postma DS, Boezen HM. Severe exacerbations predict excess lung function decline in asthma. Eur Respir J. 2007 Sep;30(3):452-6. doi: 10.1183/09031936.00165106. Epub 2007 May 30.
PubMed 175377638. P. Moraitaki, D. Papamichail, N. Georgatotu (2010) Severe Asthma: Definitions, risk factors and phenotype characterization. Pneumon, 23(3):276-292.
9. P. Latsi, M. Gaga (1999) Leukotriene antagonists, a new class of anti-asthmatic drugs. Pneumon, 12 (2): 123-132
Muneswarao J, Hassali MA, Ibrahim B, Saini B, Ali IAH, Verma AK. It is time to change the way we manage mild asthma: an update in GINA 2019. Respir Res. 2019 Aug 14;20(1):183. doi: 10.1186/s12931-019-1159-y.
PubMed 31412856Bateman ED, Reddel HK, O'Byrne PM, Barnes PJ, Zhong N, Keen C, Jorup C, Lamarca R, Siwek-Posluszna A, FitzGerald JM. As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma. N Engl J Med. 2018 May 17;378(20):1877-1887. doi: 10.1056/NEJMoa1715275.
PubMed 29768147O'Byrne PM, FitzGerald JM, Bateman ED, Barnes PJ, Zhong N, Keen C, Jorup C, Lamarca R, Ivanov S, Reddel HK. Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma. N Engl J Med. 2018 May 17;378(20):1865-1876. doi: 10.1056/NEJMoa1715274.
PubMed 29768149Rogliani P, Ritondo BL, Ora J, Cazzola M, Calzetta L. SMART and as-needed therapies in mild-to-severe asthma: a network meta-analysis. Eur Respir J. 2020 Sep 10;56(3):2000625. doi: 10.1183/13993003.00625-2020. Print 2020 Sep.
PubMed 32430423Buhl R, Kuna P, Peters MJ, Andersson TL, Naya IP, Peterson S, Rabe KF. The effect of budesonide/formoterol maintenance and reliever therapy on the risk of severe asthma exacerbations following episodes of high reliever use: an exploratory analysis of two randomised, controlled studies with comparisons to standard therapy. Respir Res. 2012 Jul 20;13(1):59. doi: 10.1186/1465-9921-13-59.
PubMed 22816878Zhong N, Lin J, Mehta P, Ngamjanyaporn P, Wu TC, Yunus F. Real-life effectiveness of budesonide/formoterol maintenance and reliever therapy in asthma patients across Asia: SMARTASIA study. BMC Pulm Med. 2013 Apr 4;13:22. doi: 10.1186/1471-2466-13-22.
PubMed 23557023
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This Study Will Record the Use of Budesonide / Formoterol Either as Maintenance Treatment or / or as Needed According to Standard Clinical Practice and at the Discretion of the Treating Physician.
- ClinicalTrials.gov ID
- NCT04835961
- Acronym / sponsor ID
- NOTOS / 2020-BUDFOR-EL-127
- Conditions
- Asthma
- Keywords
- asthma, as needed treatment, maintenance treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,037 participants (actual)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 8 Apr 2021 (actual)
- 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.
The budesonide / formoterol combination can be used both as a maintenance treatment and as a maintenance and relief therapy (MART) where in the latter there is also anti-inflammatory action in contrast to the use of SABA. This anti-inflammatory and soothing effect has been recognized by the Global Initiatives for Asthma (GINA) guidelines and is recommended as a palliative treatment for all types of asthma severity versus Short Acting Beta Agonists (SABA).
Test results have shown that the invoked budesonide / formoterol combination therapy had a similar (not lower) effect on the annual exacerbation rate, with lower exposure to ICS compared to regular maintenance therapy with inhaled corticosteroids (ICS), although budesonide / formoterol therapy appeared to was inferior to ongoing asthma control. Another study showed no inferiority of the stable budesonide / formoterol combination compared to maintenance ICS plus the required SABA dosing regimen in reducing the annual severe exacerbation rate in patients with mild asthma.
Patients receiving budesonide / formoterol as adjunctive therapy or as maintenance therapy experienced a reduced incidence of exacerbations including asthma-related SAEs, compared with patients receiving long acting beta agonists (LABAs) or SABAs as sedatives, ICS or ICS / LA terbutaline or salbutamol. Studies have shown that patients spent more days without palliative care, indicating a significant reduction in reliance on palliative care while improving both disease control and daily functioning and well-being. Asthma symptoms and nocturnal awakening were significantly reduced, and FEV1 levels before and after treatment showed significant improvement in lung function and quality of life as shown by the AQLQ-S questionnaire score. In addition, ICS / LABA therapy as a palliative or maintenance treatment appears to be well tolerated and reduces the risk of severe exacerbations following exposure to high doses of SABA which may mask the worsening of inflammation.
The meta-analysis of Rogliani et. al. showed that low dose (LD) to medium dose (MD) ICS / LABA MART was as effective as HD ICS / LABA and SABA as needed treatments in reducing the risk of severe asthma exacerbations and that MART was generally more effective than low dose LD ICS / LABA + as needed LABA or SABA, or ICS / LABA as needed or ICS + as needed SABA treatments. The efficacy of ICS / LABA as needed treatment in the risk of severe exacerbation was significantly higher than ICS + as needed SABA treatment but not ICS / LABA + as needed SABA in patients with mild to severe asthma. LD to MD MART and HD ICS / LABA + as needed SABA were equally effective (P> 0.05) in improving PEF, and more effective (P <0.05) than LD ICS / LABA + as needed SABA or LABA, ICS / LABA as needed, ICS + SABA as needed, and SABA as needed. Administration of ICS / LABA as purely invasive use significantly improved (P <0.05) PEF compared to ICS + SABA as needed, LD ICS / LABA + SABA as needed, and SABA as needed treatments. MART improved lung function and disease control compared to other invasive therapies in patients with moderate asthma. In contrast, in patients with moderate to severe asthma, LD to MD MART was partially more effective than other invasive therapies in improving lung function and controlling asthma. No differences were found in the safety profile which was measured as the risk of occurrence of YOU.
The combination of budesonide / formoterol as maintenance therapy and as-needed palliative care could improve overall asthma control without the need for additional palliative care.
Detailed description
Pulmoton® is an inhaled combination of budesonide and formoterol fumarate dihydrate in doses of 100 / 6mcg, 200 / 6mcg, 400/12 mcg, administered by Elpenhaler®, a powder inhaler developed in doses developed by the ELPEN. It has been approved as a bronchodilator in the treatment of asthma where combination therapy (ICS / LABA) is appropriate in patients who are not adequately controlled with inhaled corticosteroids and rely on short-acting inhaled β2-stimulants or in patients already satisfactorily controlled with both corticosteroids. long-acting β2-stimulants.
Pulmoton® is not recommended for the initial treatment of asthma. The dosage of the individual components of Pulmoton® is separate and must be adjusted according to the severity of the condition. This should be taken into account, not only when starting treatment with stable combination products, but also when adjusting the maintenance dosage.
The dose should be adjusted to the lowest possible, by which effective control of symptoms is achieved and maintained. Patients should be re-evaluated regularly by their physician so that the dose of Pulmoton® they receive remains the best possible. When long-term control of symptoms is achieved with the lowest recommended dose, then in the next step only the inhaled corticosteroid can be tested.
There are two alternatives to treating asthma with Pulmoton®:
- Pulmoton® Maintenance Therapy: Pulmoton® is taken as a regular maintenance treatment along with a separate rapid-acting bronchodilator to relieve symptoms.
- Pulmoton® Maintenance and Relief Therapy: Pulmoton® is also taken as regular maintenance and invocative treatment for symptoms.
Further information on the efficacy and safety of the drug under study can be found in the Product Characteristics Summary (SmPC).
Aims of the study The GINA 2020 guidelines recommend, among other things, the symptom-driven use of ICS / LABA (as needed).
This study will record the use of budesonide / formoterol either as maintenance treatment or / or as needed according to standard clinical practice and at the discretion of the treating physician.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients proflle is based on GINA 2020 guidelines that recommend, among other things, the symptom-driven use of inhaled corticosteroids / long-acting β2-stimulants (ICS / LABA) (as needed). This study will record the use of budesonide / formoterol either as maintenance treatment or / or as needed according to standard clinical practice and at the discretion of the treating physician.
Key inclusion criteria (6 listed)
- Adult patients Newly diagnosed patients with asthma without prior treatment or receiving previous low dose (LD) ICS / LABA treatment, as needed.
- Patients who are not adequately controlled with LD ICS as maintenance therapy and need to have LABA added:
- Patients who are not adequately controlled with LD or moderate (MD) ICS and LABA doses and need to have ICS / LABA added as an adjunctive therapy to treat the symptoms.
- Consent and compliance with the therapies and study procedures.
Key exclusion criteria (3 listed)
- Patients <18
- Patients with COPD
- Patients with ACO
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 |
|---|---|---|
| Maintenace and As neededThis study will record the use of budesonide / formoterol either as maintenance treatment or / or as needed according to standard clinical practice and at the discretion of the treating physician. | Other | – |
Primary outcome
Asthma control
Time frame: 6 months
Asthma control at 3 and 6 months of treatment.
3 secondary outcomes
FEV1
Time frame: 6 months
MiniAQLQ questionnaire
Time frame: 6 months
FSI-10 questionnaire
Time frame: 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 1 Nov 2023.
- Background: PubMed 32910899El-Husseini ZW, Gosens R, Dekker F, Koppelman GH. The genetics of asthma and the promise of genomics-guided drug target discovery. Lancet Respir Med. 2020 Oct;8(10):1045-1056. doi: 10.1016/S2213-2600(20)30363-5. Epub 2020 Sep 7.
- Results publication1. Global Initiative for Asthma. Gglobal Strategy for Asthma Management and Prevention. (2020) Available from: www.ginasthma.org
- Results publication: PubMed 32237004Jenkins CR, Bateman ED, Sears MR, O'Byrne PM. What have we learnt about asthma control from trials of budesonide/formoterol as maintenance and reliever? Respirology. 2020 Aug;25(8):804-815. doi: 10.1111/resp.13804. Epub 2020 Mar 31.
- Results publication: PubMed 22536582Lougheed MD, Lemiere C, Ducharme FM, Licskai C, Dell SD, Rowe BH, Fitzgerald M, Leigh R, Watson W, Boulet LP; Canadian Thoracic Society Asthma Clinical Assembly. Canadian Thoracic Society 2012 guideline update: diagnosis and management of asthma in preschoolers, children and adults. Can Respir J. 2012 Mar-Apr;19(2):127-64. doi: 10.1155/2012/635624.
- Results publication: PubMed 19770241Kaplan AG, Balter MS, Bell AD, Kim H, McIvor RA. Diagnosis of asthma in adults. CMAJ. 2009 Nov 10;181(10):E210-20. doi: 10.1503/cmaj.080006. Epub 2009 Sep 21. No abstract available.
- Results publication: PubMed 20176271Lemanske RF Jr, Busse WW. Asthma: clinical expression and molecular mechanisms. J Allergy Clin Immunol. 2010 Feb;125(2 Suppl 2):S95-102. doi: 10.1016/j.jaci.2009.10.047.
- Results publication: PubMed 17537763Bai TR, Vonk JM, Postma DS, Boezen HM. Severe exacerbations predict excess lung function decline in asthma. Eur Respir J. 2007 Sep;30(3):452-6. doi: 10.1183/09031936.00165106. Epub 2007 May 30.
- Results publication8. P. Moraitaki, D. Papamichail, N. Georgatotu (2010) Severe Asthma: Definitions, risk factors and phenotype characterization. Pneumon, 23(3):276-292.
- Results publication9. P. Latsi, M. Gaga (1999) Leukotriene antagonists, a new class of anti-asthmatic drugs. Pneumon, 12 (2): 123-132
- Results publication: PubMed 31412856Muneswarao J, Hassali MA, Ibrahim B, Saini B, Ali IAH, Verma AK. It is time to change the way we manage mild asthma: an update in GINA 2019. Respir Res. 2019 Aug 14;20(1):183. doi: 10.1186/s12931-019-1159-y.
- Results publication: PubMed 29768147Bateman ED, Reddel HK, O'Byrne PM, Barnes PJ, Zhong N, Keen C, Jorup C, Lamarca R, Siwek-Posluszna A, FitzGerald JM. As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma. N Engl J Med. 2018 May 17;378(20):1877-1887. doi: 10.1056/NEJMoa1715275.
- Results publication: PubMed 29768149O'Byrne PM, FitzGerald JM, Bateman ED, Barnes PJ, Zhong N, Keen C, Jorup C, Lamarca R, Ivanov S, Reddel HK. Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma. N Engl J Med. 2018 May 17;378(20):1865-1876. doi: 10.1056/NEJMoa1715274.
- Individual participant dataSharing planned: No
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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.
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?
An observational study of Asthma, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
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 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 1 Nov 2023. 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 Greece. 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?
Asthma control (time frame: 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 NCT04835961, which also lists 24 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 1 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.