Phase 2
Completed N=56
A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Cystic Fibrosis
Source: ClinicalTrials.gov NCT00757848 ↗Enrolled (actual)
56
Serious AEs
3.6%
Results posted
Jul 2012
Primary outcomePrimary: Ratio of Sputum Absolute Neutrophil Count at End of Treatment Compared to Baseline — 1.07; 1.10 ratio
Summary
The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Cystic Fibrosis (CF) and if so how it compares to placebo (a substance which does not have any action).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of Sputum Absolute Neutrophil Count at End of Treatment Compared to Baseline |
1.07; 1.10 | — |
| PRIMARY Sputum Percentage Neutrophil Count |
3.21; 1.96 | — |
| PRIMARY 24-hour Sputum Weight |
-2.29; -5.13 | — |
| PRIMARY Forced Expiratory Volume in 1 Second (FEV1) |
-0.02; 0.01 | — |
| PRIMARY Slow Vital Capacity (SVC) |
-0.03; -0.15 | — |
| PRIMARY Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%) |
-0.07; 0.08 | — |
| PRIMARY Forced Vital Capacity (FVC) |
-0.06; 0.01 | — |
| PRIMARY Morning Peak Expiratory Flow (PEF) |
-1.17; 14.05 | — |
| PRIMARY Evening Peak Expiratory Flow (PEF) |
0.59; 6.32 | — |
| PRIMARY Bronkotest Diary Card Signs and Symptoms |
0; 0 | — |
| PRIMARY Cystic Fibrosis Questionnaire (CFQ-R) - Quittner |
-19.7; 4.7 | — |
| SECONDARY Ratio of Sputum Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline |
0.91; 1.24 | — |
| SECONDARY Ratio of Sputum Interleukin 6 (IL-6) at End of Treatment Compared to Baseline |
0.71; 1.20 | — |
| SECONDARY Ratio of Sputum Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline |
0.95; 1.09 | — |
| SECONDARY Ratio of Sputum Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline |
0.91; 1.18 | — |
| SECONDARY Ratio of Sputum Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline |
0.73; 0.91 | — |
| SECONDARY Ratio of Sputum Interleukin 8 (IL-8) at End of Treatment Compared to Baseline |
0.86; 1.04 | — |
| SECONDARY Ratio of Sputum Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline |
1.02; 1.00 | — |
| SECONDARY Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline |
0.88; 1.27 | — |
| SECONDARY Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline |
0.68; 0.97 | — |
Eligibility Criteria
Inclusion Criteria
- Male or post-menopausal or surgically sterile female patients
- Have a clinical diagnosis of Cystic Fibrosis with lung function tests greater or equal to 40% of normal
- Have normal renal function
Exclusion Criteria
- Lung transplant patients
- Significant liver disease
- Any other non-CF-related lung disease that may interfere with study assessments
Data sourced from ClinicalTrials.gov (NCT00757848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.