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.

Phase 1

• Conditions: Bronchial Asthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-001029-34-GR
• Lead Sponsor: ELPEN Pharmaceutical Co. Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-13
• Last Update Posted: 24 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified