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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01225315




Registration number
NCT01225315
Ethics application status
Date submitted
19/10/2010
Date registered
21/10/2010
Date last updated
9/07/2018

Titles & IDs
Public title
Clinical Study to Explore the Efficacy of ACT-129968 in Patients With Partly Controlled Asthma
Scientific title
A Multi-center, Double-blind, Placebo-controlled, Parallel-group Study to Establish Proof-of-concept and Explore the Efficacy of Different Doses of ACT-129968 in Adult Patients With Partly Controlled Asthma
Secondary ID [1] 0 0
AC-060A202
Universal Trial Number (UTN)
Trial acronym
CONTROL
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Setipiprant

Experimental: Setipiprant - Dose 1 - 100 mg b.i.d.

Experimental: Setipiprant - Dose 2 - 500 mg b.i.d.

Experimental: Setipiprant - Dose 3 - 1,000 mg b.i.d

Placebo Comparator: Matching Placebo - Oral placebo


Treatment: Drugs: Placebo
Matching placebo administered orally twice daily

Treatment: Drugs: Setipiprant
ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo
Timepoint [1] 0 0
Baseline to week 12
Secondary outcome [1] 0 0
Explore the efficacy of different doses of ACT-129968 on change in lung function and asthma control
Timepoint [1] 0 0
Baseline to 12 weeks

Eligibility
Key inclusion criteria
- Signed informed consent prior to any study-mandated procedure

- Males and females age 18 to 65 years

- Women of childbearing potential must use adequate contraception

- Presenting with a diagnosis of asthma according to GINA Guidelines

- Pre-bronchodilator forced expiratory volume in one second (FEV1) < / = 85% of
patient's predicted normal value

- Reversibility of airway obstruction of > / = 12% and > / = 200mL from
pre-bronchodilator FEV1

- ACQ score > / = 1.5
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of life-threatening asthma

- Any asthma exacerbation requiring treatment with systemic corticosteroids within the
last 3 months

- Ongoing or recent treatment with medication for allergic airway disease

- Smoking within the last year, or life-time consumption > / = 10 pack-years (e.g., 20
cigarettes/day for 10 years)

- History of chronic pulmonary disease (other than asthma), such as chronic obstructive
pulmonary disease (COPD), fibrosis, tuberculosis or sarcoidosis

- Pregnant or lactating women

- Diagnosis of aspirin or non-steroidal anti-inflammatory drug (NSAID)-induced asthma

- Any hospital admission for asthma within the last 6 months

- Anti-IgE therapy at any time check/update interventions by explicitely writing the
experimental drug dosage in the interventions description

- Any circumstances or conditions, which, in the opinion of the investigator, may affect
full participation in the study or compliance with the protocol

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
1/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2012
Sample size
Target
Accrual to date
Final
438
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Clinical Investigative Site 5002 - Glebe
Recruitment hospital [2] 0 0
Clinical Investigative Site 5003 - Nedlands
Recruitment hospital [3] 0 0
Clinical Investigative Site 5001 - Sherwood
Recruitment postcode(s) [1] 0 0
2037 - Glebe
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
4075 - Sherwood
Recruitment outside Australia
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United States of America
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California
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Florida
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Illinois
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Louisiana
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Massachusetts
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Missouri
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New York
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North Carolina
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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United States of America
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Wisconsin
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Bulgaria
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Ruse
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Germany
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Berlin
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Germany
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Dortmund
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Germany
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Gelnhausen
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Germany
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Hamburg
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Germany
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Lübeck
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Germany
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Mainz
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Germany
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Rüdersdorf
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Hungary
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Budapest
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Hungary
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Csorna
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Hungary
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Miskolc
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Nyiregyhaza
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Siofok
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Sopron
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Szombathely
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Hungary
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Sátoraljaújhely
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Tatabanya
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Israel
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Ashkelon
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petach Tikvah
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Israel
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Rehovot
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Israel
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Tel-Aviv
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Poland
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Bialystok
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Krakow
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Lodz
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Lublin
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Poland
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Tarnow
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Russian Federation
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Barnaul
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Serbia
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Belgrade
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Singapore
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Singapore
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South Africa
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Bloemfontein
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South Africa
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Cape Town
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Durban
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George
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Johannesburg
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Port Elizabeth
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South Africa
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Pretoria
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Sweden
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Goteborg
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Harnosand
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Linköping
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Sweden
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Lulea
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Lund
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Sweden
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Stockholm
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Sweden
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Varberg
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Ukraine
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Donetsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Odesa
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Ukraine
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Poltava
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Ukraine
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Uzhhorod
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Ukraine
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Zaporizhia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Idorsia Pharmaceuticals Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the efficacy and safety of ACT-129968 in subjects with partly
controlled asthma on reliever therapy only.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01225315
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sara Mangialaio, MD
Address 0 0
Actelion
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
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/ct2/show/NCT01225315