| Eligibility |
Inclusion Criteria:
- Signed informed consent must be obtained prior to participation in the study.
- Male or female adult patients aged between 18 and 65 years old.
- Patients with a diagnosis of asthma for at least 6 months prior to Visit 1 with
current asthma severity of step 1-3 (GINA 2018).
- Patients with presence of allergy against house dust mite, cat or grass pollen.
- PC20 histamine or equivalent = 8 mg/ml.
- Drop in FEV1 > 20% during the early asthmatic response and drop in FEV1 > 15% during
the late asthmatic response, i.e. between 3-8 hours after allergen challenge.
- Patients able to produce sputum of sufficient quality for evaluation of cell
differential counts 24 hours after the baseline allergen challenge at Visit 3.
Exclusion Criteria:
- Smoking history = 10 pack-years. Ex-smokers are eligible for inclusion if they quit
smoking for at least 6 months prior to Visit 1.
- Diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
- FEV1 < 70% of predicted at baseline or < 1.5 liters.
- An asthma attack/exacerbation requiring systemic steroids or hospitalization or
emergency room visit within 6 weeks of Visit 1.
- Respiratory tract infection or clinically significant asthma worsening as defined by
Investigator within 4 weeks prior to Visit 1.
- Ever required intubation for a severe asthma attack/exacerbation.
- Presence of clinical condition which is likely to be worsened by ICS administration
(e.g. glaucoma, cataract and fragility fractures).
- Treated with LAMA for asthma within 3 months prior to Visit 1.
- Known with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH) or
bladder-neck obstruction or severe renal impairment or urinary retention.
- Known with any chronic conditions affecting the upper respiratory tract (e.g. chronic
sinusitis or polyposis nasi) which in the opinion of the investigator may interfere
with the study evaluation or optimal participation in the study. Allergic rhinitis is
allowed.
- History of chronic lung diseases other than asthma, including (but not limited to)
sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant
bronchiectasis and active tuberculosis.
- Uncontrolled Type I or Type II diabetes.
- Clinically significant laboratory abnormality at Visit 1.
- Use of other investigational drugs within 30 days or 5 half-lives of enrollment, until
the expected pharmacodynamics effect has returned to baseline, whichever is longer.
- Clinically significant condition such as (but not limited to) unstable ischemic heart
disease, New York Heart Association (NYHA) Class III/IV left ventricular failure,
arrhythmia, uncontrolled hypertension, cerebrovascular disease, psychiatric disease,
neurodegenerative diseases, or other neurological disease, uncontrolled hypo- and
hyperthyroidism and other autoimmune diseases, hypokalemia, hyper adrenergic state, or
ophthalmologic disorder or patients with a medical condition that might compromise
patient safety or compliance, interfere with evaluation, or preclude completion of the
study.
- Diagnosis of paroxysmal (e.g., intermittent) atrial fibrillation.
- History of myocardial infarction within 12 months prior to Visit 1.
- Concomitant use of agents known to prolong the QT interval unless it can be
permanently discontinued for the duration of study.
- History of long QT syndrome or QTc measured at Visit 1 (Fridericia method) is
prolonged (> 450 msec for males and > 460 msec for females).
- Clinically significant ECG abnormality at Visit 1.
- History of malignancy of any organ system (other than localized basal cell carcinoma
of the skin or in-situ cervical cancer), within the past 5 years, regardless of
whether there is evidence of local recurrence or metastases.
- History of hypersensitivity to lactose, any of the study drugs or its excipients, or
to similar drugs within the class including untoward reactions to sympathomimetic
amines or inhaled medication or any component thereof.
- On maintenance immunotherapy (desensitization) for allergies for less than 3 months
prior to Visit 1 or patients on Maintenance Immunotherapy for more than 3 months prior
to Visit 1 but expected to change throughout the course of the study.
- Unable to use the Breezhaler dry powder inhaler or a metered dose inhaler.
- History of alcohol or other substance abuse that based on judgement of the
investigator would interfere with study conduct.
- Known history of non-compliance to medication.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a
positive hCG laboratory test.
- Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using highly effective methods of contraception
during dosing of study treatment and for 5-times the terminal half-life after stopping
medication.
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