Phase 2
N=52
Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis
Bronchiectasis · Lung Disease · Respiratory Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01255592 ↗Enrolled (actual)
52
Serious AEs
1.9%
Results posted
Oct 2015
Primary outcome: Primary: Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline — 0.31; 1.00 ratio — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD5069 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline |
0.31; 1.00 | 0.004 sig |
| SECONDARY Ratio of the Percentage Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline |
0.66; 1.02 | 0.008 sig |
| SECONDARY Change From Baseline in Weight of 24-hour Sputum Collection |
3.51; -3.26 | 0.047 sig |
| SECONDARY Change From Baseline in Slow Vital Capacity (SVC) |
0.05; -0.05 | 0.284 |
| SECONDARY Change From Baseline in Forced Vital Capacity (FVC) |
0.07; 0.06 | 0.929 |
| SECONDARY Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) |
-0.01; -0.01 | 0.966 |
| SECONDARY Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75) |
-0.04; -0.07 | 0.791 |
| SECONDARY Transition Dyspnea Index (TDI) at End of Treatment (Day 28) |
-1; -0 | 0.433 |
| SECONDARY Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card |
-5.3; -5.9; -7.3; -10.6 | 0.935 |
| SECONDARY Change From Baseline for the Symptom Scores of the Bronkotest Diary Card |
0.1; -0.1; 0.1; 0.0; 0.4; 0.1 | 0.329 |
| SECONDARY Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) |
-1.75; -0.09; -3.16; 1.72; -0.46; 0.85 | 0.625 |
| SECONDARY Ratio of Interleukin-1 Beta (IL-1β) in Sputum at End of Treatment Compared to Baseline |
0.63; 0.91 | 0.220 |
| SECONDARY Ratio of Interleukin-6 (IL-6) in Sputum at End of Treatment Compared to Baseline |
3.68; 0.82 | <0.001 sig |
| SECONDARY Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) in Sputum at End of Treatment Compared to Baseline |
0.99; 1.07 | 0.670 |
| SECONDARY Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) in Sputum at End of Treatment Compared to Baseline |
0.91; 0.92 | 0.968 |
| SECONDARY Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Sputum at End of Treatment Compared to Baseline |
1.29; 0.91 | 0.193 |
| SECONDARY Ratio of Growth-related Oncogene-α (GRO-α) in Sputum at End of Treatment Compared to Baseline |
2.77; 0.85 | <0.001 sig |
| SECONDARY Ratio of Interleukin-8 (IL-8) in Sputum at End of Treatment Compared to Baseline |
0.81; 0.80 | 0.917 |
| SECONDARY Ratio of Neutrophil Elastase Activity in Sputum at End of Treatment Compared to Baseline |
0.34; 1.95 | 0.111 |
| SECONDARY Ratio of Serum Amyloid A (SAA) in Serum at End of Treatment Compared to Baseline |
1.18; 0.89 | 0.367 |
| SECONDARY Ratio of C-reactive Protein (CRP) in Serum at End of Treatment Compared to Baseline |
1.28; 0.83 | 0.112 |
| SECONDARY Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Serum at End of Treatment Compared to Baseline |
1.02; 0.97 | 0.241 |
| SECONDARY Ratio of Growth-related Oncogene-α (GRO-α) in Serum at End of Treatment Compared to Baseline |
5.45; 0.99 | <0.001 sig |
| SECONDARY Ratio of Interleukin-6 (IL-6) in Serum at End of Treatment Compared to Baseline |
1.13; 0.97 | 0.281 |
| SECONDARY Ratio of Interleukin-1 Beta (IL-1β) in Serum at End of Treatment Compared to Baseline |
1.45; 0.93 | 0.001 sig |
| SECONDARY Ratio of Interleukin-8 (IL-8) in Serum at End of Treatment Compared to Baseline |
5.90; 0.97 | <0.001 sig |
Summary
The purpose of this study is to investigate the effect of AZD5069 in patients with bronchiectasis.
Eligibility Criteria
Inclusion Criteria
- Male, or female of non-child bearing potential; ie, women who are permanently or surgically sterilised or post-menopausal.
- Aged 18 to 80 years inclusive at screening (Visit 1)
- Have a clinical diagnosis of idiopathic or post infective bronchiectasis as diagnosed with a historical high resolution computerised tomography (HRCT) or bronchogram
- Be sputum producers with a history of chronic expectoration on most days of most weeks of the year. Patients should have a history of spontaneously producing sputum on a daily basis and should be able to provide at least 2 of the 3 required baseline sputum samples with an average of 3 mL or more.
- Be on a stable treatment regimen, as judged by the investigator.
Exclusion Criteria
- Any clinically significant disease or disorder
- Patients with other latent or chronic infections or at risk of infection within 90 days before Visit 2
- An acute exacerbation or acute respiratory infection (upper or lower) requiring oral steroids or antibiotics within 30 days prior to Visit 2
- An FEV1 of <30% of predicted normal at Visit 1
- Patients who have received live or live-attenuated vaccine in the 2 weeks prior to dosing (Visit 2)
- Concomitant diagnosis of significant pulmonary disease other than bronchiectasis or COPD, including symptomatic asthma and allergic bronchopulmonary aspergillosis
- Bronchiectasis associated with a generalised immunodeficiency disorder, where manifestations other than bronchiectasis predominate
Data sourced from ClinicalTrials.gov (NCT01255592). 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.