Clinical trial NCT01225315: Clinical Study to Explore the Efficacy of ACT-129968 in Patients With Partly Controlled Asthma
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2010-10-21
Enrollment: 438
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy and safety of ACT-129968 in subjects with partly controlled asthma on reliever therapy only.


Eligibility criteria: 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

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

Primary outcomes:
measure: To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Explore the efficacy of different doses of ACT-129968 on change in lung function and asthma control
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Clinical Investigative Site # 6204
state: California
city: Los Angeles
country: United States
facility: Clinical Investigative Site 6208
state: California
city: Tallahassee
country: United States
facility: Clinical Investigative Site # 6219
state: Florida
city: Normal
country: United States
facility: Clinical Investigative Site 6213
state: Illinois
city: New Orleans
country: United States
facility: Clinical Investigative Site # 6215
state: Louisiana
city: North Dartmouth
country: United States
facility: Clinical Investigative Site # 6211
state: Massachusetts
city: Saint Louis
country: United States
facility: Clinical Investigative Site # 6209
state: Missouri
city: Bronx
country: United States
facility: Clinical Investigative Site 6205
state: New York
city: Winston-Salem
country: United States
facility: Clinical Investigative Site # 6223
state: North Carolina
city: Lake Oswego
country: United States
facility: Clinical Inverstigative Site #6201
state: Oregon
city: Medford
country: United States
facility: Clinical Investigative Site # 6207
state: Oregon
city: Portland
country: United States
facility: Clinical Investigative Site # 6214
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Investigative Site 6203
state: Pennsylvania
city: Greenville
country: United States
facility: Clinical Investigative Site # 6228
state: South Carolina
city: Spartanburg
country: United States
facility: Clinical Investigative Site 6230
state: South Carolina
city: Knoxville
country: United States
facility: Clinical Investigative Site 6202
state: Tennessee
city: Nashville
country: United States
facility: Clinical Investigative Site 6226
state: Tennessee
city: El Paso
country: United States
facility: Clinical Investigative Site # 6220
state: Texas
city: Fort Worth
country: United States
facility: Clinical Investigative Site # 6225
state: Texas
city: San Antonio
country: United States
facility: Clinical Investigative Site # 6222
state: Texas
city: San Antonio
country: United States
facility: Clinical Investigative Site 6229
state: Texas
city: Madison
country: United States
facility: Clinical Investigative Site # 6217
state: Wisconsin
city: Glebe
country: Australia
facility: Clinical Investigative Site 5002
city: Nedlands
country: Australia
facility: Clinical Investigative Site 5003
city: Sherwood
country: Australia
facility: Clinical Investigative Site 5001
city: Ruse
country: Bulgaria
facility: Clinical Investigative Site # 5103
city: Sofia
country: Bulgaria
facility: Clinical Investigative Site # 5101
city: Sofia
country: Bulgaria
facility: Clinical Investigative Site # 5104
city: Stara Zagora
country: Bulgaria
facility: Clinical Investigative Site # 5102
city: Berlin
country: Germany
facility: Clinical Investigative Site 5208
city: Berlin
country: Germany
facility: Clinical Investigative Site 5212
city: Dortmund
country: Germany
facility: Clinical Investigative Site 5205
city: Gelnhausen
country: Germany
facility: Clinical Investigative Site 5207
city: Hamburg
country: Germany
facility: Clinical Investigative Site 5211
city: Lübeck
country: Germany
facility: Clinical Investigative 5209
city: Mainz
country: Germany
facility: Clinical Investigative Site 5204
city: Rüdersdorf
country: Germany
facility: Clinical Investigative Site 5202
city: Budapest
country: Hungary
facility: Clinical Investigative Site 5310
city: Csorna
country: Hungary
facility: Clinical Investigative Site 5307
city: Miskolc
country: Hungary
facility: Clinical Investigative Site 5304
city: Nyiregyhaza
country: Hungary
facility: Clinical Investigative Site # 5303
city: Siofok
country: Hungary
facility: Clinical Investigative Site 5301
city: Sopron
country: Hungary
facility: Clinical Investigative Site # 5308
city: Szombathely
country: Hungary
facility: Clinical Investigative Site # 5305
city: Sátoraljaújhely
country: Hungary
facility: Clinical Investigative Site 5309
city: Tatabanya
country: Hungary
facility: Clinical Investigative Site 5302
city: Ashkelon
country: Israel
facility: Clinical Investigative Site # 5407
city: Haifa
country: Israel
facility: Clinical Investigative Site 5401
city: Jerusalem
country: Israel
facility: Clinical Investigative Site # 5402
city: Petach Tikvah
country: Israel
facility: Clinical Investigative Site 5405
city: Rehovot
country: Israel
facility: Clinical Investigative Site # 5403
city: Tel-Aviv
country: Israel
facility: Clinical Investigative Site # 5404
city: Tel-Aviv
country: Israel
facility: Clinical Investigative Site # 5406
city: Bialystok
country: Poland
facility: Clinical Investigative Site # 5507
city: Krakow
country: Poland
facility: Clinical Investigative Site # 5505
city: Lodz
country: Poland
facility: Clinical Investigative Site # 5501
city: Lublin
country: Poland
facility: Clinical Investigative Site # 5502
city: Tarnow
country: Poland
facility: Clinical Investigative Site # 5503
city: Barnaul
country: Russian Federation
facility: Clinical Investigative Site 5610
city: Barnaul
country: Russian Federation
facility: Clinical Investigative Site 5606
city: Kazan
country: Russian Federation
facility: Clinical Investigative Site 5603
city: Moscow
country: Russian Federation
facility: Clinical Investigative Site 5602
city: Moscow
country: Russian Federation
facility: Clinical Investigative Site 5654
city: Moscow
country: Russian Federation
facility: Clinical Investigative Site 5607
city: Novosibirsk
country: Russian Federation
facility: Clinical Investigative Site 5609
city: St. Petersburg
country: Russian Federation
facility: Clinical Investigative Site 5605
city: St. Petersburg
country: Russian Federation
facility: Clinical Investigative Site 5604
city: Tomsk
country: Russian Federation
facility: Clinical Investigative Site 5608
city: Belgrade
country: Serbia
facility: Clinical Investigative Site 5701
city: Belgrade
country: Serbia
facility: Clinical Investigative Site 5702
city: Singapore
country: Singapore
facility: Clinical Investigative Site 5802
city: Bloemfontein
country: South Africa
facility: Clinical Investigative Site 5908
city: Cape Town
country: South Africa
facility: Clinical Investigative Site 5905
city: Cape Town
country: South Africa
facility: Clinical Ivestigative Site 5902
city: Durban
country: South Africa
facility: Clinical Investigative Site 5901
city: George
country: South Africa
facility: Clinical Investigative Site 5909
city: Johannesburg
country: South Africa
facility: Clinical Investigative Site 5906
city: Port Elizabeth
country: South Africa
facility: Clinical Investigative Site 5910
city: Pretoria
country: South Africa
facility: Clinical Investigative Site 5903
city: Pretoria
country: South Africa
facility: Clinical Investigative Site 5907
city: Goteborg
country: Sweden
facility: Clinical Investigative Site 6001
city: Harnosand
country: Sweden
facility: Clinical Investigative Site # 6006
city: Linköping
country: Sweden
facility: Clinical Investigative Site 6003
city: Lulea
country: Sweden
facility: Clinical Investigative Site # 6002
city: Lund
country: Sweden
facility: Clinical Investigative Site 6052
city: Stockholm
country: Sweden
facility: Clinical Investigative Site 6007
city: Varberg
country: Sweden
facility: Clinical Investigative Site 6004
city: Donetsk
country: Ukraine
facility: Clinical Investigative Site # 6104
city: Kharkiv
country: Ukraine
facility: Clinical Investigative Site 6110
city: Kharkiv
country: Ukraine
facility: Clinical Investigative Site # 6101
city: Kyiv
country: Ukraine
facility: Clinical Investigative Site # 6102
city: Kyiv
country: Ukraine
facility: Clinical Investigative Site # 6103
city: Odesa
country: Ukraine
facility: Clinical Ivestigative Site 6111
city: Poltava
country: Ukraine
facility: Clinical Investigative Site 6108
city: Uzhhorod
country: Ukraine
facility: Clinical Investigative Site # 6107
city: Zaporizhia
country: Ukraine
facility: Clinical Investigative Site 6105
city: Zaporizhia
country: Ukraine
facility: Clinical Investigative Site # 6106
Study officials:
affiliation: Actelion
name: Sara Mangialaio, MD
role: STUDY_DIRECTOR
References: