Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03033758 |
| Other study ID # |
2016-HAL-EL-69 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 2, 2017 |
| Est. completion date |
December 30, 2017 |
Study information
| Verified date |
September 2022 |
| Source |
Elpen Pharmaceutical Co. Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study will be conducted in Greek population. The patients who will be selected for study
enrollment will receive inhaled combination of budesonide and formoterol fumarate dihydrate
at doses 100 / 6mcg, 200 / 6mcg, 400/12 mcg through Elpenhlaler® device. The study end points
will be efficacy and safety in patients with asthma.Additional study objectives will be
quality of life, patient satisfaction, severe exacerbation and comorbidities.
Description:
Asthma is a heterogeneous disease, usually characterized by chronic inflammation of the
airways. Characterized by a history of respiratory symptoms such as wheezing, chest heaviness
and cough symptoms that fluctuate over time, as well as variable airway obstruction.
Asthma is a common disease worldwide, the rates of which are increasing in children and
adults. It is estimated that asthma affects 1-18% of the population in different countries.
In Greece, which is a country with lower rates of asthma, it is estimated that 8.6% of the
population suffers from the disease.
The diagnosis of asthma should be based on: Background with characteristic symptoms, signs
variable airway obstruction, with tests for reversal of bronchial obstruction or other tests.
Long-term treatment of asthma has the following objectives 1. symptom control: achieve
adequate control of symptoms and maintain normal activity levels 2. Risk Reduction: minimize
risk of future exacerbations, permanent airflow obstruction and side effects from medication
Pulmoton® is an inhaled combination of budesonide and formoterol fumarate dihydrate in
portions 100 / 6mcg, 200 / 6mcg, 400/12 mcg, administered through Elpenhlaler® device,
developed by ELPEN. It is approved as a bronchodilator in the treatment of asthma where
administration of the combination (inhaled corticosteroid and long-beta2-agonist action) is
appropriate in patients not adequately controlled with inhaled corticosteroids and 'as
needed' inhaled beta2-agonists short-acting or patients already adequately controlled with
both inhaled corticosteroids and long-acting beta2-agonists.
Pulmoton® 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 considered not only at the beginning of therapy with fixed
combination products, but also when adjusting the maintenance dosage.
The dose should be adjusted to the lowest possible, to achieve and maintain effective control
of symptoms. Patients should be regularly reassessed by a doctor, so that the dose of
Pulmoton® receiving remains optimal. When you achieve long-term control of symptoms with the
lowest recommended dose, then the next step may be testing single administration of inhaled
corticosteroid.
There are two alternatives for the treatment of asthma with Pulmoton®:
A. Pulmoton® maintenance therapy: Pulmoton® taken as regular maintenance treatment with a
separate rapid-acting bronchodilator for relief of symptoms.
B. Pulmoton® maintenance and reliever therapy: Pulmoton® taken as regular maintenance and 'on
demand' therapy to treat the symptoms.
A. Pulmoton® maintenance therapy:
Patients should be advised to always carry with them their fast-acting bronchodilator to use
when there is a need for relief.
More information on the effectiveness and safety of the study drug, reported in the Summary
of Product Characteristics (Summary of Product Characteristics (SmPC)
This prospective observational study aims to collect data regarding Pulmoton® from everyday
clinical practice, improve the quality of life of patients and disease progression. The
centers where the study will be approximately 100, both hospital and private pulmonary
clinics will be held. Data will be collected for a period of 6 months from patients diagnosed
with asthma not adequately controlled with inhaled corticosteroids and 'as needed' inhaled
beta2-agonists short-acting or patients already adequately controlled on both inhaled
corticosteroids and beta2-long-acting stimulants.
Data will be collected during the period of three (3) and six (6) months (± 2 weeks) from the
initiation of treatment with inhaled combination include spirometry data, (FEV1, FVC, FEV /
FVC), checklist ACQ, AQLQ questionnaire and questionnaire FSI 10, and details of any existing
comorbidities.
