Mild allergic asthma MedDRA version: 20.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855
Conditions
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: AGE 1. Between 18 and 65 years of age inclusive, at the time of signing the informed consent. TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY 2. Diagnosis of asthma, as defined by the history of respiratory symptoms such as wheeze, shortness of breath, chest tightness and cough that vary over time and in intensity, together with variable expiratory airflow limitation [GINA guideline, 2015] for at least 6 months prior to screening. 3. Current asthma therapy. Intermittent short-acting beta-agonist (SABA) alone (on average for no more than 2 days per week) 4. Positive skin prick test (3 mm or more greater than negative control) to common perennial or seasonal aeroallergen(s) (i.e., house dust mite, cat dander, grass pollen) at screening. 5. Pre-bronchodilator FEV1 > 70 % predicted normal at Screening Visit 1 NOTE: Predicted values will be based upon Quanjer, 2012. 6. EAR with =20 % FEV1 decrease between 5 and 30 minutes after the final allergen concentration is obtained at the screening bronchial allergen challenge (decreases relative to the saline). 7. LAR with three FEV1 decreases of =15 % between 4 and 10 hours after the final allergen concentration is obtained at the screening bronchial allergen challenge, with two FEV1 decreases being at consecutive time points (decreases relative to the saline). 8. Subjects who are current non-smokers (defined as no use of any tobacco products in the 6-month period preceding the screening visit) and have a pack history of < 10 pack years Number of pack years = (number of cigarettes per day/20) x number of years smoked WEIGHT 9. Bodyweight = 45kg SEX 10. Male OR female of non-reproductive potential Males: Male subjects with female partners of child bearing potential must comply with one of the following contraception requirements from the time of first dose of study medication until the final follow-up visit. a. Vasectomy with documentation of azoospermia. b. Male condom plus partner use of one of the contraceptive options below: - Contraceptive subdermal implant - Intrauterine device or intrauterine system - Oral contraceptive, either combined or progestogen alone [Hatcher, 2007a] Injectable progestogen [Hatcher, 2007a] - Contraceptive vaginal ring [Hatcher, 2007a] - Percutaneous contraceptive patches [Hatcher, 2007a] This is an all-inclusive list of those methods that meet the following GSK definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product methods (e.g., male sterility), the investigator determines what is consistent and correct use. The GSK definition is based on the definition provided by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) [ICH M3 (R2) 2009].” The investigator is responsible for ensuring that subjects understa
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: CONCURRENT CONDITIONS/MEDICAL HISTORY (INCLUDES LIVER FUNCTION AND QTc INTERVAL) 1. Alanine transaminase (ALT) >2xUpper Limit of Normal (ULN) and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin 450 msec or QTc > 480 msec in subjects with Bundle Branch Block NOTES: - The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Fridericia’s formula (QTcF), or another method, machine-read or manually over-read. - The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the owest QTc value used to include or discontinue the subject from the trial. - For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used as specified in the Reporting and Analysis Plan (RAP). 4. Asthma exacerbation requiring treatment with oral corticosteroids or hospitalization within 3 months prior to screening 5. History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 10 years. 6. Evidence of concurrent respiratory diseases such as pneumonia, pneumothroax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other respiratory abnormalities other than asthma. 7. Other concurrent diseases/abnormalities: A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study. 8. Respiratory tract infection that is not resolved within 2 weeks prior to screening. CONCOMITANT MEDICATIONS 9. Treatment with intranasal steroid, inhaled corticosteroid (ICS) with or without longacting beta2-agonist (LABA), and treatment with non-ICS controller asthma medications (i.e., leukotriene modifier, methylxanthines) within 4 weeks prior to screening. 10. Use of long-acting antihistamines within 7 days’ or short-acting antihistamines within 72 hours prior to the screening skin prick test. 11. Treatment with systemic corticosteroids within 6 weeks prior to screening. 12. Use of inhaled SABAs as rescue treatment on average for more than 2 days per week. RELEVANT HABITS 13. History of regular alcohol consumption within 6 months of the study defined as:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of treatment with i.n. GSK2245035 compared to placebo on the allergen-induced late asthmatic response (LAR) in subjects with allergic asthma.;Secondary Objective: To evaluate the effect of treatment with i.n. GSK2245035 compared to placebo on the allergen-induced early asthmatic response (EAR) in subjects with allergic asthma.; Primary end point(s): Late Asthmatic Response: minimum FEV1 between 4-10 hours following allergen challenge one week after treatment. Late Asthmatic Response: weighted mean FEV1 between 4-10 hours following allergen challenge one week after treatment. ;Timepoint(s) of evaluation of this end point: FEV1 values up to 10 hours following administration of the bronchial allergen challenge | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Early Asthmatic Response: minimum FEV1 between 0-2 hours following allergen challenge one week after treatment. Early Asthmatic Response: weighted mean FEV1 between 0-2 hours following allergen challenge one week after treatment. ;Timepoint(s) of evaluation of this end point: FEV1 values up to 2 hours following administration of the bronchial allergen challenge | — |
Countries
Germany, United Kingdom
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed