A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis.Estudio fase II de distribución aleatoria, doble ciego, controlado con placebo y de grupos paralelos, para evaluar la eficacia de la administración oral durante 28 días de AZD1236 a pacientes adultos con fibrosis quística - CYBER

• Conditions: Cystic FibrosisFibrosis quística; MedDRA version: 9.1Level: LLTClassification code 10011763Term: Cystic fibrosis lung

• Registration Number: EUCTR2008-004699-34-ES
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-25
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Provision of informed consent prior to any study specific procedures
2. Be male or post-menopausal/surgically sterile female (total hysterectomy and/or bilateral total ophorectomy) > 18 years old
3. Have a clinical diagnosis of cystic fibrosis with an FEV1 =40% of predicted normal
4. Be able to comply with induced sputum procedure

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

1. Significant portal hypertension in the opinion of the Investigator
2. Any clinically relevant disease or disorder (past or present), 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
3. Concomitant diagnosis of significant pulmonary disease other than CF-related lung disease, including symptomatic asthma and allergic bronchopulmonary aspergillosis
4. A clinical suspicion of active or latent tuberculosis defined as any of the following: positive tuberculosis test (such as Quantiferon GOLD), and/or suspicion of active or latent tuberculosis on chest X-ray taken within last 12 months, and/or past medical history of tuberculosis
5. An acute exacerbation (defined as, an increase in respiratory symptoms requiring hospitalisation and/or a course of oral glucocorticosteroids and/or antibiotics, either prescribed or self administered); or acute respiratory infection (upper or lower) requiring oral steroids or antibiotics in the 4 weeks prior to Visit 2
6. Vaccination (killed vaccine) within 1 week before each biomarker sampling (see Table 2). For live vaccine, the limit is 4 weeks before Visit 2. Vaccination is accepted 1 week after last dose (Visit 4)
7. Acute respiratory infection with fever in the two weeks prior to Visit 2, or other acute infections requiring treatment with antibiotics, fungicides or anthelmintica in the 4 weeks before Visit 2
8. Use of oral corticosteroids in the 8 weeks prior to Visit 2 (use of inhaled corticosteroids is allowed as long as dose remains stable in the 4 weeks before Visit 2)
9. Use of antibiotics (systemic or nebuliser) in the 4 weeks prior to Visit 2 (except prophylactic treatment – acceptable if unchanged for 8 weeks prior to Visit 2), macrolides or tetracyclins not allowed
10. Treatment with any immunomodulatory agents within 8 weeks prior to Visit 2
11. Increased Cardiac Troponin I>Upper Limit of Normal (ULN) at screening (Visit 1)
12. Any clinically relevant abnormal finding in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study
13. Patients with glomerular filtration rate less than 60 mL/min, calculated as creatinine clearance from serum-creatinine according to the Cockcroft and Gault formula: (CLcreatinine (mL/min)=constant x (140-age) x weight (kg)/serum creatinine (µM). Constant being 1.23 for men and 1.04 for women
14. Patients with underlying musculoskeletal symptoms of unknown origin and patients with shoulder girdle musculoskeletal symptoms or Dupuytrens contracture symptoms as judged by the investigator
15. Suspected or known risk of the patient transmitting HIV, hepatitis B or C via infected blood
16. Known to be infected with Burkholderia cepacia
17. Scheduled in-patient surgery or hospitalisation during the course of the study
18. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
19. Previous randomisation of treatment in the present study
20. Known or suspected hypersensitivity to study therapy or excipient of the investigational product.
21. Participation in another clinical study involving an investigational product within 12 weeks of Visit 1
If the patient participates in the genetic part of the s

Study & Design

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