Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis (STRATUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01255592
First received: December 2, 2010
Last updated: September 25, 2012
Last verified: September 2012

December 2, 2010
September 25, 2012
February 2011
February 2012   (final data collection date for primary outcome measure)
Absolute cell count [ Time Frame: The patients will be enrolled into the study at Visit 1. Visit 1a and Visit 1b to take place 7 days prior to Visit 2 (randomization) and the treatment period will last 28 days (±2 days) to Visit 4, i.e. a maximum of 35 days ± 2. ] [ Designated as safety issue: No ]
Absolute neutrophil cell count in sputum
Same as current
Complete list of historical versions of study NCT01255592 on ClinicalTrials.gov Archive Site
  • Percentage cell count [ Time Frame: The patients will be enrolled into the study at Visit 1. Visit 1a and Visit 1b to take place 7 days prior to Visit 2 (randomization) and the treatment period will last 28 days (±2 days) to Visit 4, i.e. a maximum of 35 days ± 2. ] [ Designated as safety issue: No ]
    Percentage neutrophil cell count in sputum
  • Signs and symptoms [ Time Frame: From enrolment to 7 days after the last dose. ] [ Designated as safety issue: No ]
    Signs and symptoms of bronchiectasis (including effects on quality of life)
  • Safety and tolerability [ Time Frame: From enrolment to 7 days after the last dose. ] [ Designated as safety issue: Yes ]
    Safety and tolerability variables (Adverse Events, ECG, physical examination, safety blood samples, vital signs, body temperature, lung function tests)
  • Inflammatory markers in sputum [ Time Frame: The patients will be enrolled into the study at Visit 1. Visit 1a and Visit 1b to take place 7 days prior to Visit 2 (randomization) and the treatment period will last 28 days (±2 days) to Visit 4, i.e. a maximum of 35 days ± 2. ] [ Designated as safety issue: No ]
    Effect of AZD5069 on other inflammatory markers in sputum
  • Inflammatory markers in blood [ Time Frame: The patients will be enrolled into the study at Visit 1. Visit 1a and Visit 1b to take place 7 days prior to Visit 2 (randomization) and the treatment period will last 28 days (±2 days) to Visit 4, i.e. a maximum of 35 days ± 2. ] [ Designated as safety issue: No ]
    Effect of AZD5069 on inflammatory markers in blood
  • Plasma pharmacokinetics [ Time Frame: From first dose to 2 hours after the last dose. ] [ Designated as safety issue: No ]
    Plasma pharmacokinetics of AZD5069 in this patient population
Same as current
Not Provided
Not Provided
 
Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis
A Phase II Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28-Day Oral Administration of AZD5069 Twice Daily in Patients With Bronchiectasis

The purpose of this study is to investigate the effect of AZD5069 in patients with bronchiectasis.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Bronchiectasis
  • Lung Disease
  • Respiratory Diseases
  • Drug: AZD5069
    Oral dose bid
  • Drug: Placebo
    Oral dose bid
  • Experimental: 1
    Treatment arm AZD5069
    Intervention: Drug: AZD5069
  • Placebo Comparator: 2
    Placebo dose.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Poland,   United Kingdom
 
NCT01255592
D3550C00014
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Bengt Larsson,, M.B AstraZeneca R&D Mölndal
AstraZeneca
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP