Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis

NCT00812045 | Withdrawn Phase 2

• 1 other identifier: D4260C00008
• Study Type: interventional
• Target: 44
• Locations: 4 countries
• Sites: 10

Brief Summary

The purpose of this study is to determine the effect of AZD1236 in patients with cystic fibrosis (CF) on inflammatory biomarkers in induced sputum, after a treatment period of 4 weeks.

Conditions

Cystic Fibrosis

Keywords

Induced sputum; cystic fibrosis; biomarker; CYBER

Outcome Measures

Primary Outcomes (2)

• Effect on biomarker levels in induced sputum

  2 times at baseline and after 4 weeks treatment

• Signs and symptoms (Lung function variables by spirometry, symptom scores from Diary and Health-related quality of life Questionnaire)

  At inclusion, at randomisation and after 4 weeks treatment

Secondary Outcomes (3)

• Safety and tolerability (adverse events, vital signs and laboratory safety variables)

  throughout study (at inclusion, randomisation, after 4 weeks treatments and at follow-up)

• Effect on biomarkers in blood

  2 times, at baseline and after 4 weeks treatment

• Effect on biomarkers in urine

  2 times, at baseline and after 4 weeks treatment

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD1236

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD1236 DRUG

Oral tablet, 75 mg twice daily during 4 weeks

1

Placebo DRUG

2

Eligibility Criteria

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

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Have a clinical diagnosis of cystic fibrosis with an FEV1 \>40% of predicted normal
• Be able to comply with induced sputum procedure
• post-menopausal surgically sterile female (total hysterectomy and /or bilateral total oophorectomy)

You may not qualify if:

• Concomitant diagnosis of significant pulmonary disease other than CF-related lung disease, including symptomatic asthma and allergic bronchopulmonary aspergillosis
• Treatment with any immunomodulatory agents within 8 weeks prior to Visit 2
• Known to be infected with Burkholderia cepacia

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (10)

Research Site

Montreal, Canada

Location

Research Site

Ottawa, Canada

Location

Research Site

Vancouver, Canada

Location

Research Site

Amsterdam, Netherlands

Location

Research Site

Groningen, Netherlands

Location

Research Site

Utrecht, Netherlands

Location

Research Site

Gdansk, Poland

Location

Research Site

Poznan, Poland

Location

Research Site

Barcelona, Catalonia, Spain

Location

Research Site

Madrid, Madrid, Spain

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

4-((5-chloro-2-pyridinyl)oxy)-1-((((4S)-4-methyl-2,5-dioxo-4-imidazolidinyl)methyl)sulfonyl)-piperidine

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Andrew J Lockton, MD

  AstraZeneca R&D Charnwood

  STUDY DIRECTOR

• Shawn Aaron, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: December 1, 2009
• Study Completion: August 1, 2010
• Last Updated: May 6, 2009

Record last verified: 2009-05

Locations

ES (2); CA (3); NL (3); PL (2)