EUCTR2008-004699-34-ES
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cystic FibrosisFibrosis quística
- Sponsor
- AstraZeneca AB
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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