A 4-week, phase-II, double-blind, placebo-controlled, randomized, parallel group, multi-centre study to assess the efficacy and tolerability/safety of inhaled AZD3199 once daily compared to 9 µg formoterol bid and placebo in patients with moderate to severe COPD - GLAD

• Conditions: Chronic obstructive pulmonary disease (COPD); MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD

• Registration Number: EUCTR2009-011265-82-BG
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

For inclusion in the study patients must fulfil the following criteria:

1. Provision of informed consent prior to any study specific procedures
2. Men or women, aged =40 years. Women must be of non-childbearing potential or
must have used a highly effective contraceptive method for the last 3 months prior
to Visit 1 (the start date of the run-in period).
3. Clinical diagnosis of COPD, with symptoms for more than 1 year
4. Current or ex-smokers with a smoking history of at least 10 pack years
5. 40% = FEV1 <80% of the predicted normal value (post-bronchodilator) and
post-bronchodilator FEV1/FVC < 70%
Randomization criteria at Visit 2:
6. Total AZ COPD symptom scores =2 per day for at least half the number of days of
the run-in period (by totalling the breathlessness, cough, chest tightness and night
time awakening scores from the diary)
7. FEV1 pre-bronchodilator must be reproducible within a maximum of 8 attempts
For voluntary participation in the genetic part of the study:
8. Provision of informed consent for genetic part of 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients must not enter the study if any of the following exclusion criteria are fulfilled:

1. Current or a history of asthma
2. A history of atopic disease, such as allergic rhinitis, before 40 years of age
3. Any current respiratory tract disorder other than COPD, including respiratory
diseases described in GOLD 2008 or JRS Guidelines 2004 as needed to be
differentiated from COPD, which is considered by the investigator to be clinically
significant
4. Significant disease or disorder (e.g. cardiovascular, pulmonary other than COPD,
gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic,
malignant, psychiatric, major physical impairment) which, in the opinion of the
investigator, may either put the patient at risk because of participation in the study,
or influence the results of the study, or the patient’s ability to participate in the study
5. Any clinically relevant abnormal findings in clinical chemistry, haematology,
urinalysis, physical examination, pulse, blood pressure or ECG at Visit 1, which,
in the opinion of the investigator, may put the patient at risk because of his/her
participation in the study
6. Body mass index (BMI) <18 kg/m2 or a body weight <30 kg
7. A marked baseline prolongation of QT and/or QTcF (QTcF interval > 450 ms or
QT > 500 ms for both males and females)
8. A history of additional risk factors for Torsade de Pointes (eg, heart failure,
hypokalemia, family history of Long QT syndrome)
9. Requirement for regular oxygen therapy
10. An exacerbation of COPD (defined as use of systemic antibiotics and/or systemic
glucocorticosteroids and/or hospitalisation related to COPD) within 30 days of
Visit 1 (the start date of the run-in period)
11. Known or suspected hypersensitivity to study therapy or excipients of the
investigational product
12. Pregnancy or lactation
13. Past or present alcohol or drug abuse
14. Participation in another study involving blood donation (>500 ml) within 3 months
of Visit 1 (the start date of the run-in period)
15. A suspected/manifested infection according to IATA categories A and B
16. Participation in any clinical study with an investigational drug or new formulation
of a marketed drug in the 3 months prior to Visit 1(the start date of the run-in
period)
17. Planned in-patient surgery or hospitalisation during the study.
18. Previous enrolment into the present study
19. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
For voluntary participation in the genetic part of the study:
20. Previous bone marrow transplant
21. Whole blood transfusion within 120 days of the date of genetic sample collection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified