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Completed

NCT Number: NCT00758706

A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients

The primary aim of this study is to investigate the effects of AZD1236 compared with placebo ("inactive substance") in COPD patients by analysing biomarkers for inflammation and tissue degradation in blood, urine and sputum.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of COPD for 1 month
  • Men or postmenopausal women
  • Spirometry values indicating symptomatic patients
  • Smoking history equivalent to using 20 cigarettes a day for 10 years.

Exclusion criteria

  • Any current respiratory tract disorders other than COPD
  • Requirement for regular oxygen therapy
  • Acute worsening of COPD (exacerbation) 1,5 month prior to study drug administration
  • Use of oral or parenteral glucocorticosteroids within 30 days and use of inhaled steroids 14 days prior to the study

Treatment and study plan

AZD1236

Drug

oral tablet, 75 mg, twice daily during 6 weeks

Placebo

Drug

Dosing to match AZD1236

Primary outcomes

  1. Ratio of TNF Alpha at Week 6 to Baseline

    Time frame: Baseline and Week 6

    Ratio reflects Sputum Tumor Necrosis Factor alpha (TNF alpha) at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).

  2. Ratio of Sputum Total Cells at Week 6 to Baseline

    Time frame: Baseline and Week 6

    Ratio reflects Sputum Total Cells at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).

  3. Ratio of Total Urine Desmosine at Week 6 to Baseline

    Time frame: Baseline and Week 6

    Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.

Secondary outcomes

  1. Incidence of Adverse Events

    Time frame: all study visits

    Number of patients who had an AE

  2. Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6

    Time frame: Baseline and Week 6

    Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.

  3. Change From Baseline in Forced Vital Capacity (FVC) at Week 6

    Time frame: Baseline and Week 6

    Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.

  4. Change From Baseline in Vital Capacity (VC) at Week 6

    Time frame: Baseline and Week 6

    Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.

  5. Change From Baseline in Inspiratory Capacity (IC) at Week 6

    Time frame: Baseline and Week 6

    Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.

  6. Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Week 6

    Time frame: Baseline and Week 6

    Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.

  7. Change From Baseline in Peak Expiratory Flow (PEF) Morning at Average of Last 4 Week Treatment

    Time frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

    Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.

  8. Change From Baseline in Peak Expiratory Flow (PEF) Evening at Average of Last 4 Week Treatment

    Time frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

    Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.

  9. Change From Baseline in Clinical COPD Questionnaire(CCQ) Total

    Time frame: Baseline and Week 6

    Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)

  10. Change From Baseline in COPD Symptoms, Breathlessness at Average of Last 4 Week Treatment

    Time frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

    Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).

  11. Change From Baseline in COPD Symptoms, Chest Tightness at Average of Last 4 Week Treatment

    Time frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

    Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).

  12. Change From Baseline in COPD Symptoms, Cough Score at Average of Last 4 Week Treatment

    Time frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

    Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).

  13. Change From Baseline in COPD Symptoms, Night Time Awakenings at Average of Last 4 Week Treatment

    Time frame: Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)

    Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Double-blind, Randomised, Placebo-controlled, Parallel Group Multi-centre Phase IIa Study to Assess the Effects on Biomarkers in Induced Sputum, Bood and Uine of AZD1236 Administered as Oral Tablet in Moderate to Severe COPD Patients During a 6 Week Period.

Acronym: BICO

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 25, 2008
Registry last updated
Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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