A 4 week randomised, double blind, placebo controlled, parallel group, phase II, PoP study to assess the efficacy and safety of AZD1981 in adult patients with asthma.
- Conditions
- Asthma
- Registration Number
- EUCTR2006-001193-25-GB
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 22
1. Provision of ICF (Informed Consent Form) could be obtained at an information
visit prior to Visit 1 or at Visit 1 (according to local regulations), but before any
study related procedures has been performed.
2. Men and post menopausal or surgically sterilized women, aged 18-60 years.
Women will be considered post menopausal if they have been amenorrheic for at
least 12 months, and an FSH plasma concentration within the post menopausal
range as defined by the laboratory.
3. Minimum of 6 month’s documented history of asthma according to the ATS
definition (ATS 1987).
4. Daily use of =400 µg inhaled GCS during 30 days prior to Visit 1.
5. FEV1 =60 - <100% of predicted normal value pre-bronchodilator.
6. Reversible airway obstruction either according to the reversibility test performed
at Visit 1, or as historic data found in medical record (not older than 2 years)
Reversibility is defined as an increase in FEV1 of =12% relative baseline and
=200 mL after an inhalation of in total 1 mg Bricanyl Turbuhaler. If not fulfilled at
Visit 1, criterion No 11 should be fulfilled at Visit 2.
7. The patient must not have had a clinically important asthma exacerbation, as
judged by the investigator, one month before Visit 1.
8. A positive skin prick test to airway allergens (at least one) such as: pollen from
birch, grass, or mugwort, animal fur for example dog, cat, horse, or house dust
mite at Visit 1 or as historic data found in medical records not older than 2 years.
9. Able to read and write and use electronic devices.
10. Use of as-needed medication at least 4 times during the last week of the run-in
period.
11. If the reversibility criterion is not met at Visit 1 (either from historic data or
from the spirometry measurement) the patient must either show an increase in
FEV1 of =12% relative baseline and =200 mL after an inhalation of in total 1 mg
Bricanyl Turbuhaler or show a variation in PEF of at least 20% on at least 2 days
during the run-in period. This should be calculated as follows: (max PEF - min
PEF) / max PEF (all values from the same day).
12. The patient must not have taken more than 12 inhalations of as-needed medication
on any single day during the run-in period.
13. The patient must not have had a clinically important asthma exacerbation, as
judged by the investigator, during the run-in period.
14. Patients must not have used 8 inhalations or more of as-needed medication/24
hours on more than 2 days/week (any 7 days period) during the run-in period.
15. The patient must not have used iGCS during the run-in period.
16. No clinical relevant abnormal findings in clinical chemistry, haematology, FSH
(females only), urinalysis, which, in the opinion of the investigator, may put
patient at risk because of his/her participation in the study.
17. Provision of informed consent for pharmacogen
1. Inability to tolerate withdrawal of asthma therapy as required for the study.
2. Hospitalisation for asthma within the last 2 years prior to Visit 1.
3. Respiratory infection significantly affecting the asthma, as judged by the
investigator, within 30 days prior to Visit 1.
4. Any of the following:
- current smoker,
- patient with a history of smoking for more than 10 pack years (one pack year= 1
pack (20 cigarettes) per day for 1 year or equivalent),
- ex-smoker since less than 1 year.
5. Body Mass Index (BMI) <18 kg/m 2 and body weight <50 kg.
6. A history of additional risk factors for Torsade de pointes (eg, heart failure,
hypokalemia, family history of Long QT syndrome).
7. Use of concomitant medications that prolong the QT/QTc interval other than
terbutaline or albuterol.
8. Use of ß -blocker medication (including eye-drops)
9. Pregnancy or breast feeding.
10. Any significant disorder (eg, cardiovascular, pulmonary (other than asthma),
gastrointestinal, hepatic, renal, neurological, musculosceletal, infectious,
endocrine, metabolic, malignant, psychiatric, major physical impairment) which,
in the opinion of the investigator, either put the patient at risk because of
participating in the study or may influence the results of the study, or the patients
ability to participate in the study.
11. Any clinical relevant abnormal findings in physical examination, pulse, blood
pressure or ECG at Visit 1, which, in the opinion of the investigator, may put
patient at risk because of his/her participation in the study.
12. Previous randomisation of treatment into the present study, see Section 3.5.
13. Planned hospitalisation during the course of the study.
14. Suspected poor capability to follow instructions of the study, as judged by the
investigator.
15. Past or present alcohol or drug abuse.
16. Involvement in the planning and conduct of the study (applies to both AstraZeneca
staff and staff at the study site).
17. Patients currently on immunotherapy, or who have had a course within the last
2 years.
18. Participation in another clinical study involving an investigational product within
3 months before Visit 1.
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