A Randomised, Double Blind, Placebo-Controlled, Multi-Centre, Parallel Group Study to Evaluate the Efficacy and Safety of ADC3680 Administered Once Daily as an Add-On Therapy to Inhaled Corticosteroids and when Co-Administered with Montelukast in Subjects with Inadequately-Controlled Asthma.
- Conditions
- asthmaMedDRA version: 17.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2012-003966-42-CZ
- Lead Sponsor
- Pulmagen Therapeutics LLP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 248
? Male or female subjects aged 18 to 50 years inclusive.
? A diagnosis of asthma according to the GINA guidelines, including a demonstration of reversible airway obstruction at screening (Visit 2) or randomisation (Visit 3).
? Reversible airway obstruction is defined as either a post-bronchodilator increase in FEV1 of = 12% and = 200 ml over the subject’s pre-bronchodilator value in litres; or an increase of = 10% in FEV1 % predicted when compared with the subject’s pre-bronchodilator value.
? Subjects with a pre-bronchodilator FEV1 value = 40% and = 85% of the predicted normal value at screening (Visit 2) and baseline (Visit 3).
? A score of 1.5 or greater on the Asthma Control Questionnaire at screening (Visit 2) and at baseline (Visit 3).
? Receiving a low to moderate dose of an inhaled corticosteroid (equivalent to budesonide = 800 µg per day) at a stable dose for at least 4 weeks before Visit 1.
? Prescribed a short-acting inhaled bronchodilator as reliever therapy for relief of symptoms.
? A peripheral blood eosinophil count = 0.17 x 109/L at Visit 1.
? Non-smoker or former smoker with a smoking history of = 10 pack years who has not smoked for at least 6 months before screening (Visit 2) and has a negative urine cotinine at Visit 2.
? Body mass index (BMI) = 17 and = 35 kg/m2.
? Able to understand the nature of the study and comply with the protocol requirements, instructions and restrictions.
? Able to provide signed and dated written informed consent to participate in 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 248
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects who are pregnant or breast-feeding. Female subjects of childbearing potential who do not agree to use an adequate method of contraception and female subjects who do not provide a negative pregnancy test prior to receiving study drug.
? Severe asthma exacerbation (defined as requiring treatment with oral or injectable corticosteroids, an emergency room visit or hospitalisation in the 4 weeks before Visit 1 or during the pre-treatment period).
? Respiratory tract infection requiring treatment with antibiotics or a change in asthma therapy in the 4 weeks before Visit 1 or during the pre-treatment period.
? A decrease in FEV1 and pre-bronchodilator PEF of at least 20% at baseline (Visit 3) when compared with the screening (Visit 2) values.
? An increase in ACQ total score of 2.0 or more at baseline (Visit 3) when compared with the ACQ total score at screening (Visit 2).
? Known cause of eosinophilia other than allergic airways disease.
? Seasonal allergies that will necessitate introduction of intra-nasal corticosteroids during the study.
? Oral ß2 agonists, long-acting inhaled anticholinergics, LABAs, methylxanthines or cromones taken in the 4 weeks before randomisation (Visit 3) or leukotriene receptor antagonists or monoclonal antibody therapy 12 weeks before randomisation (Visit 3). Subjects who have received allergen immunotherapy within the previous 12 months are not eligible to participate in the study. Subjects who are taking oral beta blockers are not eligible to participate in the study.
? Diagnosed with COPD or other relevant lung diseases (e.g., tuberculosis, bronchiolitis, a1-antitrypsin deficiency, interstitial lung disease, fibrosis, sarcoidosis, cystic fibrosis, bronchiectasis).
? Abnormal and clinically significant safety laboratory values indicating an underlying unknown concomitant disease that requires further evaluation.
? Subjects who, in the judgment of the investigator, have a clinically significant condition such as (but not limited to) cardiovascular, gastrointestinal, hepatic, renal, haematological, endocrine, metabolic, psychiatric or neurological disease that might compromise subject safety or compliance, interfere with evaluation, or preclude completion of the study.Subjects with malignant disease are excluded, unless they have had a primary cancer treated at least 10 years previously with no subsequent evidence of recurrence, or have a basal cell skin cancer only.
? History of intolerance to leukotriene receptor antagonists.
? History of lactose intolerance.
? History of alcohol or substance abuse.
? Has participated in a study with an investigational inhaled corticosteroid or a long acting bronchodilator (anti-cholinergic or beta 2 agonist) alone or in combination in the previous 4 weeks, has participated in a study with any other new molecular entity in the previous 12 weeks, has already been randomised into this study, or has an affiliation with either the Sponsor or the study centre.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method