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
  Purpose

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


Condition Intervention Phase
Bronchiectasis
Lung Disease
Respiratory Diseases
Drug: AZD5069
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 83
Study Start Date: February 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Treatment arm AZD5069
Drug: AZD5069
Oral dose bid
Placebo Comparator: 2
Placebo dose.
Drug: Placebo
Oral dose bid

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255592

Locations
Czech Republic
Research Site
Ostrava, Czech Republic
Research Site
Prague, Czech Republic
Poland
Research Site
Krakow, Poland
Research Site
Lodz, Poland
Research Site
Warszawa, Poland
United Kingdom
Research Site
Hull, East Yorkshire, United Kingdom
Research Site
Leicester, Leicestershire, United Kingdom
Research Site
Birmingham, Wstmid, United Kingdom
Research Site
Belfast, United Kingdom
Research Site
Bristol, United Kingdom
Research Site
Cambridge, United Kingdom
Research Site
London, United Kingdom
Research Site
Newcastle-upon-tyne, United Kingdom
Research Site
Salford, United Kingdom
Research Site
Wolverhampton, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Bengt Larsson,, M.B AstraZeneca R&D Mölndal
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01255592     History of Changes
Other Study ID Numbers: D3550C00014
Study First Received: December 2, 2010
Last Updated: September 25, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by AstraZeneca:
Bronchiectasis
Neutrophil
Respiratory disease
Sputum

Additional relevant MeSH terms:
Bronchiectasis
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on April 17, 2014