Status:
COMPLETED
AdditioN of Fixed Dose Combination (FDC) Of Budesonide/Formoterol Via Elpenhaler® Device in Greek Patients With asThma accΟrding to Standard Clinical Practice.
Lead Sponsor:
Elpen Pharmaceutical Co. Inc.
Conditions:
Asthma
Eligibility:
All Genders
18-80 years
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 contras...
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 dev...
Eligibility Criteria
Inclusion
- 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
- Patients \<18
- Patients with COPD
- Patients with ACO
Key Trial Info
Start Date :
May 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
1037 Patients enrolled
Trial Details
Trial ID
NCT04835961
Start Date
May 1 2021
End Date
July 1 2022
Last Update
November 1 2023
Active Locations (1)
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1
Sotiria Hospital
Athens, Greece