Stable, persistent, moderate asthma
Conditions
Interventions
Product Name: Budesonide Test DPI
Product Code: Test DPI
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Budesonide
Concentration unit: µg microgram(s)
Concentration type: equal
Concentrat
Sponsors
Neolab Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent given by patient. 2. Male or female patients between 18 and 65 years of age inclusive. 3. Inhaled corticosteroid (ICS) naïve or taking = 800 µg beclomethasone dipropionate (BDP) per day, or equivalent 4. Symptomatic patients suffering from stable, persistent, moderate asthma as defined by GINA Guidelines and for whom FEV1 is = 60% and =80% of that predicted by European Community for Coal and Steel. (Confirmation of the criteria will be made at randomisation.) 5. Willing to use effective contraceptive measures such as oral contraceptive or intra-uterine device (IUD) (women of childbearing potential only). 6. In the opinion of the investigator, able and willing to comply with the requirements of the protocol. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity to BUD or any other constituents of the Test or Reference DPI 2. Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the patient or which might interfere with the study. 3. Females who are pregnant, lactating or planning to become pregnant. 4. Currently not a smoker or who has ceased smoking at least 6 months previously. 5. Clinically significant laboratory value, as judged by the investigator. 6. Patients who have previously been enrolled into this study. 7. Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the screening visit. 8. Patients who are scheduled to receive any other investigational drug during the course of the study. 9. Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the effect of the Test DPI and Reference DPI in vivo on airway responsiveness as measured by the methacholine challenge test. ;Secondary Objective: Secondary objectives include assessment of the effect of the two treatments on spirometry evaluations, exhaled nitric oxide, asthma symptoms and the ratio of overnight urinary cortisol to creatinine. Other assessments of safety include vital signs, laboratory assessments and adverse events. ;Primary end point(s): Primary Endpoint: • Change from placebo in methacholine airway responsiveness measured as PC20 for each treatment Secondary Endpoints: Efficacy • Change from placebo in Peak Expiratory Flow (PEF), Forced Expiratory Volume in one second (FEV1) and Forced Expiratory Flow (FEF25-75) for each treatment • Change from placebo in exhaled nitric oxide for each treatment • Change from placebo in impact on asthma symptom scores for each treatment Safety • Change from placebo in the ratio of the concentration of cortisol to creatinine in urine samples collected overnight (2200h - 0800h) for each treatment • Vital signs • Adverse Events • Laboratory assessments | — |
Countries
United Kingdom
Outcome results
None listed