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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00048009




Registration number
NCT00048009
Ethics application status
Date submitted
24/10/2002
Date registered
25/10/2002
Date last updated
19/06/2017

Titles & IDs
Public title
Evaluation of Various Doses of Ro 27-2771 (Test Drug) in Asthmatic Patients Not Treated With Inhaled Corticosteroids
Scientific title
Secondary ID [1] 0 0
BA16631
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Persistent asthma for more than one year
* Current treatment for asthma with short acting inhaled beta 2 agonists (such as albuterol) only
* In good health ad demonstrated by medical history and physical exam
* Negative urine pregnancy test
* Commitment to use two forms of effective contraception simultaneously throughout the study duration and for one month after discontinuing therapy
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Asthma necessitating treatment with inhaled corticosteroids for at least one month before the start of the study
* History of severe asthma necessitating the use of oral/injectable corticosteroids within the last 2 months and/and or two bursts in the last year
* Undergoing allergy shots unless on a stable maintenance dose for three months before the start of the study
* History of chronic pulmonary diseases other than asthma
* Treatment of conditions other than asthma with oral corticosteroids within one month of the start of the study
* Current tobacco use
* Smoking history of greater than 10 pack-year history of cigarette smoking (number of packs smoked per day times the number of years smoked)
* History or evidence of drug or alcohol abuse
* Diagnosis or evidence of an infectious illness within one month of Visit 1
* Clinically significant diseases as assessed by the study doctor
* Participation in another clinical study with an experimental drug within one month of start of the study

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/10/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/02/2004
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Brisbane
Recruitment hospital [3] 0 0
- Melbourne
Recruitment hospital [4] 0 0
- Perth
Recruitment hospital [5] 0 0
- Sydney
Recruitment hospital [6] 0 0
- Woodville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment postcode(s) [3] 0 0
3050 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Perth
Recruitment postcode(s) [5] 0 0
2139 - Sydney
Recruitment postcode(s) [6] 0 0
5011 - Woodville
Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kansas
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Louisiana
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Massachusetts
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Minnesota
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Missouri
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Montana
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Nebraska
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Nevada
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Texas
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Utah
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Washington
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West Virginia
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United States of America
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Wisconsin
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Canada
State/province [31] 0 0
British Columbia
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Canada
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Ontario
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Canada
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Quebec
Country [34] 0 0
Mexico
State/province [34] 0 0
Chihuahua
Country [35] 0 0
Mexico
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Guadalajara
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Mexico
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Merida
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Mexico
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Mexico City
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Mexico
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Mexico, Df
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Mexico
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Mexico
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Mexico
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Monterrey
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Mexico
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Puebla
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Puerto Rico
State/province [42] 0 0
Ponce

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the appropriate dose of Ro 27-2441 (test drug) to be used in future studies, assess the efficacy and safety, and the anti-inflammatory action of the test drug in the treatment of asthmatic patients who are not currently receiving chronic therapy with corticosteroids. The research is being conducted at up to 80 clinical research sites in the US, Mexico, and Canada. Study participants will have a number of visits to a research site over approximately a 4-month period.
Trial website
https://clinicaltrials.gov/study/NCT00048009
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00048009