Mild Persistent Asthma
Conditions
Brief summary
The aim of this exploratory investigation is to evaluate if the Forced Expiratory Volume in the 1st second (FEV1) measurements, fractional exhaled nitric oxide (FENO) and Provocative Concentration 20 (PC20) after Adenosine Monophosphate (AMP) bronchial challenge evaluated after administration of a fixed combination of a Long-acting Beta-2-agonist (LABA) and an Inhaled Corticosteroid (ICS) at increasing doses may be suitable to demonstrate a dose response.
Interventions
DRUGBDP/formoterol
pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 4 inhalations bid (total daily dose 800 µg BDP + 48 µg formoterol)
DRUGPlacebo
pressurised metered dose inhaler
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female patients 18-50 years of age, who have signed an informed consent form. 2. Clinical evidence of asthma 3. Steroid naïve asthmatic patients 4. FEV1 at Screening Visit is \>70 % of the predicted value and at least 2.0 L. 5. Body Mass Index between 18 and 35. 6. Sensitivity to AMP at Screening Visit. 7. FENO levels \>25 ppb at the Screening Visit
Exclusion criteria
1. Having received an investigational product within 2 months of Screening Visit. 2. Inability to comply with study procedures or with study treatment intake. 3. Any significant lung disease which is considered by the investigator to be clinically significant. 4. Patients who suffer from Chronic Obstructive Pulmonary Disease (COPD) 5. Previous or current smokers who have a smoking history greater than 5 pack years. 6. Patients with any uncontrolled disease that might, in the judgment of the investigator, place the patients at undue risk or potentially compromise the results or interpretation of the study. 7. Patients with QTc \>450msec at the Screening Visit. 8. Patients with serum potassium \<3.5 mEq/L or \>6 mEq/L. 9. Intolerance/hypersensitivity or any contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids. 10. Patients who have a history of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance. 11. Patients who have undergone major surgery in the previous 3 months. 12. Patients who have had an exacerbation of asthma, requiring treatment with oral steroids during the last month prior to Screening Visit. 13. Patients treated with slow-release corticosteroids 2 months prior to Screening Visit. 14. Patients currently treated with anti-IgE Antibodies. 15. Patients who have had a respiratory tract infection within 4-weeks prior to Screening Visit. 16. Females not willing to use effective contraceptive measures such as oral contraceptive or intra-uterine device (IUD). 17. Females who are pregnant, lactating or planning to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung function | from 0 to 4 h post dose | FEV1 area under the curve from 0 to 4 hour post dose (AUC0-4h) |
| PC20 after AMP challenge | 4 h post dose | Provocative Concentration of AMP causing a 20% fall in FEV1. |
| Fractional Exhaled Nitric Oxide (FeNO) | 4 h post dose | Fractional exhaled nitric oxide (ppb). FeNO is a biomarker measured in a breath test and it is a validated method for measuring the airway inflammation in asthma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FENO | 2 h post dose | Fractional exhaled nitric oxide |
Countries
United Kingdom
Outcome results
None listed