Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis

NCT01255592 | Completed Phase 2 Results

• 1 other identifier: D3550C00014
• Study Type: interventional
• Target: 83
• Locations: 3 countries
• Sites: 15

Brief Summary

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

Conditions

Bronchiectasis; Lung Disease; Respiratory Diseases

Keywords

Bronchiectasis; Neutrophil; Respiratory disease; Sputum

Outcome Measures

Primary Outcomes (1)

• Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline

  Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.

  End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.

Secondary Outcomes (25)

• Ratio of the Percentage Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline

  End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.

• Change From Baseline in Weight of 24-hour Sputum Collection

  Baseline and end of treatment (Day 28)

• Change From Baseline in Slow Vital Capacity (SVC)

  Baseline to end of treatment (Day 28)

• Change From Baseline in Forced Vital Capacity (FVC)

  Baseline to end of treatment (Day 28)

• Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

  Baseline to end of treatment (Day 28)

Study Arms (2)

1

EXPERIMENTAL

Treatment arm AZD5069

Drug: AZD5069

2

PLACEBO COMPARATOR

Placebo dose.

Drug: Placebo

Interventions

AZD5069 DRUG

Oral dose bid

1

Placebo DRUG

Oral dose bid

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (15)

Research Site

Ostrava, Czechia

Location

Research Site

Prague, Czechia

Location

Research Site

Krakow, Poland

Location

Research Site

Lodz, Poland

Location

Research Site

Warsaw, Poland

Location

Research Site

Hull, East Yorkshire, United Kingdom

Location

Research Site

Leicester, Leicestershire, United Kingdom

Location

Research Site

Birmingham, Wstmid, United Kingdom

Location

Research Site

Belfast, United Kingdom

Location

Research Site

Bristol, United Kingdom

Location

Research Site

Cambridge, United Kingdom

Location

Research Site

London, United Kingdom

Location

Research Site

Newcastle upon Tyne, United Kingdom

Location

Research Site

Salford, United Kingdom

Location

Research Site

Wolverhampton, United Kingdom

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Bronchiectasis; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Interventions

N-(2-(2,3-difluoro-6-benzylthio)-6-(3,4-dihydroxybutan-2-yloxy)pyrimidin-4-yl)azetidine-1-sulfonamide

Condition Hierarchy (Ancestors)

Bronchial Diseases

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Bengt Larsson,, M.B

  AstraZeneca R&D Mölndal

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 7, 2010
• Study Start: February 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: October 8, 2015
• Results First Posted: October 8, 2015

Record last verified: 2015-09

Locations

CZ (2); PL (3); GB (10)