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Trial registered on ANZCTR


Registration number
ACTRN12610000345088
Ethics application status
Approved
Date submitted
15/04/2010
Date registered
29/04/2010
Date last updated
29/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Dose-Ranging Study of the Effects of SCH 527123 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
A Dose-Ranging Study of the Effects of SCH 527123 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Secondary ID [1] 251663 0
NCT01006616 (ClinicalTrials.gov)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to Severe Chronic Obstructive Pulmonary Disease 257187 0
Condition category
Condition code
Respiratory 257323 257323 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: 10mgs SCH 527123 administered orally once daily for 26 weeks
Arm 2: 30mgs SCH 527123 administered orally once daily for 26 weeks
Arm 3: 50mgs SCH 527123 administered orally once daily for 26 weeks
Intervention code [1] 256322 0
Treatment: Drugs
Comparator / control treatment
Arm 4: Opaque, blue placebo capsules containing white to off-white powder administered orally once daily for 26 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 258229 0
To assess the efficacy of three dose levels (10 mg, 30 mg, and 50 mg) of SCH 527123 compared with placebo in subjects with moderate to severe chronic obstructive pulmonary disease (COPD), based on changes from Baseline in post-bronchodilator forced expiratory volume in one second (FEV1).
Timepoint [1] 258229 0
Assessed at baseline, after 1, 2, 4, 8, 12, 16, 20 and 26 weeks of treatment and then 1 week after study treatment has stopped.
Secondary outcome [1] 263896 0
Evaluate the safety and tolerability of SCH 527123 in subjects with COPD. Asessments include vital signs, electrocardiographs (ECG), blood and urine analysis and the monitoring of adverse events such as colds, sore throat, flu, headaches, indigestion, fractured limbs, chest pain. The study doctors will question subjects on any events that may have occurred between their study visits.
Timepoint [1] 263896 0
Assessed at baseline, after 1 day of treatment, then after 1, 2, 4, 8, 12, 16, 20 and 26 weeks of treatment and then 1 week after study treatment has stopped.
Secondary outcome [2] 264029 0
Evaluate the effect of SCH 527123 on other lung function measures. Asessments include spirometry, body plethysmography and collection of induced sputum samples.
Timepoint [2] 264029 0
Assessed at baseline, after 1, 2, 4, 8, 12, 16, 20 and 26 weeks of treatment and then 1 week after study treatment has stopped.
Secondary outcome [3] 264030 0
Evaluate the effect of SCH 527123 on COPD exacerbations and symptoms. Assessment will be through the completion of a daily electronic diary.
Timepoint [3] 264030 0
Assessed at baseline, after 1, 2, 4, 8, 12, 16, 20 and 26 weeks of treatment and then 1 week after study treatment has stopped.
Secondary outcome [4] 264031 0
Evaluate the effect of SCH 527123 on activity and health-related quality of life measures. Assessment include the six minute walk test and the completion of the following questionnaires: Subject Comment Card, the St George's Respiratory Questionnaire, the Borg Scale and the Modified Medical Research Council Dyspnoea Scale.
Timepoint [4] 264031 0
Assessed at baseline then after 8 and 26 weeks of treatment.
Secondary outcome [5] 264032 0
Evaluate the effect of SCH 527123 on plasma and sputum inflammatory markers. Asessment will be through blood analysis and the collection of induced sputum samples.
Timepoint [5] 264032 0
Assessed at baseline then after 8 and 26 weeks of treatment.

Eligibility
Key inclusion criteria
1. Has a diagnosis of clinically stable COPD (indicated by no exacerbations or changes in treatment within 6 weeks of screening.
2. Has a history for 3 months or more of sputum production most days of week.
3. Must be an ex-smoker with at least 6-months smoking cessation or a current smker with a smoking history of 10 or more pack-years.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has been diagnosed with asthma or other clinically relevant lung disease.
2. Has undergone a lobectomy, pneumonectomy, lung volume reduction or other lung surgery.
3. Needs supplemental oxygen therapy for more than 12 hours per day.
4. A low white cell count at the screening visit.
5. Subjects using medication that may interfere with the effect of the study medication or has a clinically relevant medical condition that interferes with study procedures/evaluations or any condition that is determined to be significant by the principal investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256824 0
Commercial sector/Industry
Name [1] 256824 0
Schering-Plough
Country [1] 256824 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Schering-Plough
Address
2000 Galloping Hill Road,
Kenilworth, New Jersey 07033
Country
United States of America
Secondary sponsor category [1] 256102 0
None
Name [1] 256102 0
Address [1] 256102 0
Country [1] 256102 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31059 0
Address 31059 0
Country 31059 0
Phone 31059 0
Fax 31059 0
Email 31059 0
Contact person for public queries
Name 14306 0
Zoe Armstrong
Address 14306 0
Level 4, 66 Waterloo Road
North Ryde, NSW 2113
Country 14306 0
Australia
Phone 14306 0
61 2 8988 8138
Fax 14306 0
Email 14306 0
[email protected]
Contact person for scientific queries
Name 5234 0
Zoe Armstrong
Address 5234 0
Level 4, 66 Waterloo Road
North Ryde, NSW 2113
Country 5234 0
Australia
Phone 5234 0
61 2 8988 8138
Fax 5234 0
Email 5234 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.