NCT04835961: NOTOS

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

Completed Last updated 1 November 2023

What this trial tests

trial testing Maintenace and As needed in Asthma in 1,037 participants. Completed in 1 July 2022.

Timeline

1 May 2021

Primary endpoint
1 July 2022

1 July 2022

Quick facts

Lead sponsor	Elpen Pharmaceutical Co. Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,037
Start date	1 May 2021
Primary completion	1 July 2022
Estimated completion	1 July 2022
Sites	1 location across Greece

Drugs / interventions tested

• Maintenace and As needed

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

Elpen Pharmaceutical Co. Inc. — full company profile →

Who can join

Adults 18 to 80, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Real-Life Effectiveness of Budesonide/Formoterol as Maintenance and Reliever Treatment via the Elpenhaler&lt;sup&gt;®&lt;/sup&gt; Device in Patients with Asthma: The NOTOS Observational Study.
   Gogali A, Rovina N, Samitas K, Steiropoulos P, et al · · 2025 · cited 1× · PMID 40292343 · DOI 10.2147/jaa.s517932