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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT01023516
Date of registration: 01/12/2009
Primary sponsor: AstraZeneca
Public title: Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol
Scientific title: A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multinational, Phase IIb Study to Evaluate the Efficacy and Safety of 60mg AZD9668 Administered Orally Twice Daily to Subjects With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Budesonide/Formoterol
Date of first enrolment: November 2009
Target sample size: 615
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01023516
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Countries of recruitment
Bulgaria Czech Republic Hungary Poland Romania Slovakia
Contacts
Name:   Piotr Kuna, Professor
Address: 
Telephone:
Email:
Affiliation:  Samodzielny Publiczny ZOZ Uniwersytecki Szpital Kliniczny
Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of COPD with symptoms over 1 year

- FEV1/FVC < 70% and FEV1 >= 30 and < 80 % of predicted post-bronchodilator

- Symptomatic COPD for a total of 7 days in the two weeks prior to randomisation

- At least 1 COPD exacerbation from 4 weeks to 12 months before the screening visit

Exclusion Criteria:

- Past history or current evidence of clinically significant heart disease

- Current diagnosis of asthma

- Patients who require long term oxygen therapy

- Worsening of COPD requiring treatment with antibiotics, an increase in inhaled
steroid dose and/or oral steroids within 4 weeks of study visit 1b



Age minimum: 40 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Chronic Obstructive Pulmonary Disease (COPD)
Intervention(s)
Drug: AZD9668
Drug: Placebo
Primary Outcome(s)
Baseline Pre-bronchodilator FEV1 (L) [Time Frame: Day 1]
End-value Pre-bronchodilator FEV1 (L) [Time Frame: up to week 12]
Secondary Outcome(s)
Baseline Post-bronchodilator FEF25-75% (L/Sec) [Time Frame: Day 1]
Baseline Post-bronchodilator FEV6 (L) [Time Frame: Day 1]
Baseline Pre-bronchodilator FEF25-75% (L/Sec) [Time Frame: Day 1]
Baseline Pre-bronchodilator FEV6 (L) [Time Frame: Day 1]
BCSS - Baseline Total Score [Time Frame: Baseline]
BCSS - End-value Total Score [Time Frame: Last 6 weeks on treatment]
End-value Post-bronchodilator FEF25-75% (L/Sec) [Time Frame: up to week 12]
End-value Post-bronchodilator FEV6 (L) [Time Frame: up to week 12]
End-value Pre-bronchodilator FEF25-75% (L/Sec) [Time Frame: up to week 12]
End-value Pre-bronchodilator FEV6 (L) [Time Frame: up to week 12]
Endurance Shuttle Walk Test - Baseline [Time Frame: Day 1]
Endurance Shuttle Walk Test - End Value [Time Frame: Week 12 - visit 6]
Exacerbations - Clinic Defined [Time Frame: Duration of the the treatment period - 12 weeks]
EXACT - Baseline Total Score [Time Frame: Baseline]
EXACT - End-value Total Score [Time Frame: Last 6 weeks on treatment]
FEV1 - Baseline Measured by Patient at Home (L) in the Morning [Time Frame: Baseline]
FEV1 - End-value Measured by Patient at Home (L) in the Morning [Time Frame: Last 6 weeks on treatment]
Incremental Shuttle Walk Test - Baseline [Time Frame: Day 1]
Incremental Shuttle Walk Test - End Value [Time Frame: Week 12 - visit 6]
PEF - Baseline Measured by Patient at Home (L/Min) in the Morning [Time Frame: Baseline]
PEF - End-value Measured by Patient at Home (L/Min) in the Morning [Time Frame: Last 6 weeks on treatment]
Post-bronchodilator FEV1 (L) - Baseline [Time Frame: Day 1]
Post-bronchodilator FEV1 (L) - End-value [Time Frame: up to week 12]
Post-bronchodilator FVC (L) - Baseline [Time Frame: Day 1]
Post-bronchodilator FVC (L) - End-value [Time Frame: up to week 12]
Post-bronchodilator IC (L) - Baseline [Time Frame: Day 1]
Post-bronchodilator IC (L) - End-value [Time Frame: up to week 12]
Pre-bronchodilator FVC (L) - Baseline [Time Frame: Day 1]
Pre-bronchodilator FVC (L) - End-value [Time Frame: up to week 12]
Pre-bronchodilator IC (L) - Baseline [Time Frame: Day 1]
Pre-bronchodilator IC (L) - End-value [Time Frame: up to week 12]
Sputum Colour - Baseline [Time Frame: Baseline]
Sputum Colour - End Value [Time Frame: End of treatment week 12]
St George's Respiratory Questionnaire (COPD) - End-value Overall Score [Time Frame: Measured Day 1 and 12 weeks]
St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline [Time Frame: Day 1]
Use of Reliever Medication [Time Frame: Last 6 weeks on treatment]
Secondary ID(s)
D0520C00020
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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