The inhaled combination of budesonide-formoterol consists a basic asthma treatment. A helpful specific index for the prognosis of future exacerbation risk and deterioration of lung function,is the Exhaled Nitric Oxide. The objective of the current study is the evaluation of Pulmoton- Elpenhaler in Exhaled Nitric Oxide of patients with bronchial asthma.

• Register: EUCTR
• Last refreshed on: 24 July 2017
• Main ID: EUCTR2014-001029-34-GR
• Date of registration: 13/10/2015
• Prospective Registration: No
• Primary sponsor: ELPEN Pharmaceutical Co. Inc
• Public title: The inhaled combination of budesonide-formoterol consists a basic asthma treatment. A helpful specific index for the prognosis of future exacerbation risk and deterioration of lung function,is the Exhaled Nitric Oxide. The objective of the current study is the evaluation of Pulmoton- Elpenhaler in Exhaled Nitric Oxide of patients with bronchial asthma.
• Scientific title: Evaluation of the effect of the inhaled combination budesonide -formoterol (Pulmoton® Elpenhaler®) in exhaled nitric oxide (FeNO) of patients with bronchial asthma. - Effect of Pulmoton Elpenhaler in FeNO of patients with bronchial asthma
• Date of first enrolment: 07/10/2015
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001029-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: innovator SYMBICORT Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Greece

Contacts

• Name: Katerina Vidanopoulou
• Affiliation: ELPEN Pharmaceutical Co. Inc.

• Name: Katerina Vidanopoulou
• Affiliation: ELPEN Pharmaceutical Co. Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects eligible for enrolment in the study must meet all of the following criteria.
1) Eligible ages for the study: 18-65 years
2) Eligible for studying gender: Men and Women
3) Non smokers
4) History compatible with asthma and clinical diagnosis of asthma
5) Improvement in FEV1> 12% and> 200ml in spirometry in bronchodilation test
6) FeNO> 30ppb
7) Patients who have fully understand the study protocol and signed the consent form
8) Patients with asthma, who are not treated with ICS or montelukast for the last three months prior to entering the study
9) Patients who are not treated corticosteroids for the last three months prior to entering the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1 ) Patients with hypersensitivity to budesonide, formoterol or lactose
2 ) Patients , regardless of gender , age <18 years
3 ) Patients with asthma,treated with montelukast or ICS for the last three months prior entering the study
4 ) Patients being treated with corticosteroids fot the last three months prior entering the study
5) Patients treated with potent CYP3A4 inhibitor
6 ) Patients with severe cardiovascular disease or prolongation of QTc
7) Patients with untreated hypokalaemia
8) Patients with severe liver cirrhosis
9) Patients with thyrotoxicosis , pheochromocytoma or diabetes
10) Patients with other lung disease ( COPD, bronchiectasis , allergic rhinitis without treatment , etc . )
11) Patients during asthma exacerbation
12) Female patients who are pregnant , breastfeeding or planning to become pregnant
13) Patients with known existing tumor or autoimmune disease known
14) Patients with known psychiatric illness, or other condition which interferes with patient compliance to the procedures of the study
15) Patients with respiratory infection the last 8 weeks
16) Patients with severe asthma



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Bronchial Asthma

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Trade Name: Pulmoton/Elpenhaler (200/6)mcg
Product Name: Pulmoton/Elpenhaler
Pharmaceutical Form: Inhalation powder

Trade Name: Symbicort Turbuhaler
Product Name: Symbicort Turbuhaler
Pharmaceutical Form: Inhalation powder

Primary Outcome(s)

Main Objective: The primary objective of this study is the evaluation of the effect of inhaled combination of budesonide - formoterol (Pulmoton® Elpenhaler®) in exhaled nitric oxide (FeNO) of patients with bronchial asthma.

Primary end point(s): The change in the mean value of the exhaled nitric oxide (FeNO) between visits.The price will be expressed in parts per Billiard (ppb).
All study sites will use the same type of analyzer NIOX® MINO and the recommendations of ATS for measuring FeNO,will be taken into consideration in order to exclude variations in the measurements.

Secondary Objective: Secondary objectives :
- Comparison of the effect of Pulmoton® Elpenhaler® in FeNO, in patients with asthma, with the reference product Symbicort® Turbuhaler®.
- Investigation of correlation between the existence of improvement ( reduction ) of FeNO with spirometry and the score of ACT questionnaire, by treatment group .
- Collection of demographic data and safety .

Timepoint(s) of evaluation of this end point: baseline,4 weeks and 8 weeks

Secondary Outcome(s)

Secondary end point(s): Secondary variables of this study are:
- The score of the ACT questionnaire , and
- The FEV1 value recorded during the spirometry test.

Timepoint(s) of evaluation of this end point: Between visits

Secondary ID(s)

2014-BUDFOR-EL-47

Source(s) of Monetary Support

ELPEN Pharmaceutical Co. Inc.