AdditioN of Fixed Dose Combination (FDC) Of Budesonide/Formoterol Via Elpenhaler® Device in Greek Patients With asThma accΟrding to Standard Clinical Practice.

NCT04835961 | Completed

• 1 other identifier: 2020-BUDFOR-EL-127
• Study Type: observational
• Target: 1,037
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Asthma

Keywords

asthma; as needed treatment; maintenance treatment

Outcome Measures

Primary Outcomes (1)

• Asthma control

  Asthma control at 3 and 6 months of treatment.

  6 months

Secondary Outcomes (3)

• FEV1

  6 months

• MiniAQLQ questionnaire

  6 months

• FSI-10 questionnaire

  6 months

Interventions

Maintenace and As needed OTHER

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients \<18
• Patients with COPD
• Patients with ACO

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (1)

Sotiria Hospital

Athens, Greece

Location

Related Publications (24)

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  PMID: 32910899 BACKGROUND

• 1. Global Initiative for Asthma. Gglobal Strategy for Asthma Management and Prevention. (2020) Available from: www.ginasthma.org

  RESULT

• 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.

  PMID: 32237004 RESULT

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  PMID: 22536582 RESULT

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  PMID: 19770241 RESULT

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  PMID: 20176271 RESULT

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  PMID: 17537763 RESULT

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  RESULT

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  RESULT

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  PMID: 31412856 RESULT

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  PMID: 29768147 RESULT

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  PMID: 29768149 RESULT

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  PMID: 32430423 RESULT

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  PMID: 22816878 RESULT

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  PMID: 23557023 RESULT

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  PMID: 29400090 RESULT

• International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.. ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001 Jan-Mar;47(1):45-50. No abstract available.

  PMID: 11590294 RESULT

• 19. World Medical Association Declaration of Helsinki. Ethical principles for Medical Research Involving Human Subjects, Helsinki 1964, amended in Tokyo 1975, Venice 1983, Hong Kong 1989, Somerset West 1996, Edinburgh 2000, Washington DC 2002, Tokyo 2004, Seoul 2008 and Fortaleza 2013.

  RESULT

• Epstein M; International Society of Pharmacoepidemiology. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2005 Aug;14(8):589-95. doi: 10.1002/pds.1082. No abstract available.

  PMID: 15918159 RESULT

• Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. doi: 10.1034/j.1399-3003.1999.14d29.x.

  PMID: 10573240 RESULT

• Grammatopoulou E, Skordilis E, Koutsouki D, Baltopoulos G. An 18-item standardized Asthma Quality of Life Questionnaire-AQLQ(S). Qual Life Res. 2008 Mar;17(2):323-32. doi: 10.1007/s11136-007-9297-y. Epub 2007 Dec 14.

  PMID: 18080214 RESULT

• Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J. 1999 Jul;14(1):32-8. doi: 10.1034/j.1399-3003.1999.14a08.x.

  PMID: 10489826 RESULT

• 25. Grekas N., Athanassiou A., Iskos C., Panagiotakos D., Papataxiarchou A., Porichi O. (2011). Reliability of the FSI-10 questionnaire for the assessment of the usability of drug inhalers in Greek patients. Archives of Hellenic Medicine, 28(2):257-260

  RESULT

• Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, Casale TB, Chanez P, Enright PL, Gibson PG, de Jongste JC, Kerstjens HA, Lazarus SC, Levy ML, O'Byrne PM, Partridge MR, Pavord ID, Sears MR, Sterk PJ, Stoloff SW, Sullivan SD, Szefler SJ, Thomas MD, Wenzel SE; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009 Jul 1;180(1):59-99. doi: 10.1164/rccm.200801-060ST.

  PMID: 19535666 RESULT

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 8, 2021
• Study Start: May 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)