Clinical trial NCT04835961: AdditioN of Fixed Dose Combination (FDC) Of Budesonide/Formoterol Via Elpenhaler® Device in Greek Patients With asThma accΟrding to Standard Clinical Practice.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma
as needed treatment
maintenance treatment
Lead sponsor: Elpen Pharmaceutical Co. Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-08
Enrollment: 1037
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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®:

A. Pulmoton® Maintenance Therapy: Pulmoton® is taken as a regular maintenance treatment along with a separate rapid-acting bronchodilator to relieve symptoms.

B. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

Patients \<18

* Patients with COPD
* Patients with ACO

Primary outcomes:
measure: Asthma control
timeFrame: 6 months
Secondary outcomes:
measure: FEV1
timeFrame: 6 months
measure: MiniAQLQ questionnaire
timeFrame: 6 months
measure: FSI-10 questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Sotiria Hospital
Study officials:
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