Clinical Study to Explore the Efficacy of ACT-129968 in Patients With Partly Controlled Asthma

NCT01225315 | Completed Phase 2 DMC

• 1 other identifier: AC-060A202
• Study Type: interventional
• Target: 438
• Locations: 12 countries
• Sites: 95

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo

  Baseline to week 12

Secondary Outcomes (1)

• Explore the efficacy of different doses of ACT-129968 on change in lung function and asthma control

  Baseline to 12 weeks

Study Arms (4)

Setipiprant - Dose 1

EXPERIMENTAL

100 mg b.i.d.

Drug: Setipiprant

Setipiprant - Dose 2

EXPERIMENTAL

500 mg b.i.d.

Drug: Setipiprant

Setipiprant - Dose 3

EXPERIMENTAL

1,000 mg b.i.d

Drug: Setipiprant

Matching Placebo

PLACEBO COMPARATOR

Oral placebo

Drug: Placebo

Interventions

Placebo DRUG

Matching placebo administered orally twice daily

Also known as: matching placebo

Matching Placebo

Setipiprant DRUG

ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily

Also known as: ACT-129968

Setipiprant - Dose 1; Setipiprant - Dose 2; Setipiprant - Dose 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (97)

Clinical Investigative Site # 6204

Los Angeles, California, 90025, United States

Location

Clinical Investigative Site 6208

Los Angeles, California, 90095, United States

Location

Clinical Investigative Site # 6219

Tallahassee, Florida, 32308, United States

Location

Clinical Investigative Site 6213

Normal, Illinois, 61761, United States

Location

Clinical Investigative Site # 6215

New Orleans, Louisiana, 70112, United States

Location

Clinical Investigative Site # 6211

North Dartmouth, Massachusetts, 02747, United States

Location

Clinical Investigative Site # 6209

St Louis, Missouri, 63141, United States

Location

Clinical Investigative Site 6205

The Bronx, New York, 10461, United States

Location

Clinical Investigative Site # 6223

Winston-Salem, North Carolina, 27157, United States

Location

Clinical Inverstigative Site #6201

Lake Oswego, Oregon, 97035, United States

Location

Clinical Investigative Site # 6207

Medford, Oregon, 97504, United States

Location

Clinical Investigative Site # 6214

Portland, Oregon, 97213, United States

Location

Clinical Investigative Site 6203

Philadelphia, Pennsylvania, 19107, United States

Location

Clinical Investigative Site # 6228

Greenville, South Carolina, 29615, United States

Location

Clinical Investigative Site 6230

Spartanburg, South Carolina, 29303, United States

Location

Clinical Investigative Site 6202

Knoxville, Tennessee, 37909, United States

Location

Clinical Investigative Site 6226

Nashville, Tennessee, 37208, United States

Location

Clinical Investigative Site # 6220

El Paso, Texas, 79903, United States

Location

Clinical Investigative Site # 6225

Fort Worth, Texas, 76132, United States

Location

Clinical Investigative Site # 6222

San Antonio, Texas, 78229, United States

Location

Clinical Investigative Site 6229

San Antonio, Texas, 78229, United States

Location

Clinical Investigative Site # 6217

Madison, Wisconsin, 53792, United States

Location

Clinical Investigative Site 5002

Glebe, 2037, Australia

Location

Clinical Investigative Site 5003

Nedlands, 6009, Australia

Location

Clinical Investigative Site 5001

Sherwood, 4075, Australia

Location

Clinical Investigative Site # 5103

Rousse, 7002, Bulgaria

Location

Clinical Investigative Site # 5101

Sofia, 1431, Bulgaria

Location

Clinical Investigative Site # 5104

Sofia, 1431, Bulgaria

Location

Clinical Investigative Site # 5102

Stara Zagora, 6003, Bulgaria

Location

Clinical Investigative Site 5208

Berlin, 10969, Germany

Location

Clinical Investigative Site 5212

Berlin, 12165, Germany

Location

Clinical Investigative Site 5205

Dortmund, 44263, Germany

Location

Clinical Investigative Site 5207

Gelnhausen, 63571, Germany

Location

Clinical Investigative Site 5211

Hamburg, 20357, Germany

Location

Clinical Investigative 5209

Lübeck, 23552, Germany

Location

Clinical Investigative Site 5204

Mainz, 55116, Germany

Location

Clinical Investigative Site 5202

Rüdersdorf, 15562, Germany

Location

Clinical Investigative Site 5310

Budapest, 1036, Hungary

Location

Clinical Investigative Site 5307

Csorna, 9300, Hungary

Location

Clinical Investigative Site 5304

Miskolc, 3529, Hungary

Location

Clinical Investigative Site # 5303

Nyíregyháza, 4400, Hungary

Location

Clinical Investigative Site 5309

Sátoraljaújhely, 3980, Hungary

Location

Clinical Investigative Site 5301

Siófok, 8600, Hungary

Location

Clinical Investigative Site # 5308

Sopron, 9400, Hungary

Location

Clinical Investigative Site # 5305

Szombathely, H-9700, Hungary

Location

Clinical Investigative Site 5302

Tatabánya, H-2800, Hungary

Location

Clinical Investigative Site # 5407

Ashkelon, 78278, Israel

Location

Clinical Investigative Site 5401

Haifa, 34362, Israel

Location

Clinical Investigative Site # 5402

Jerusalem, 91120, Israel

Location

Clinical Investigative Site 5405

Petach Tikvah, 49100, Israel

Location

Clinical Investigative Site # 5403

Rehovot, 76100, Israel

Location

Clinical Investigative Site # 5404

Tel Aviv, 64239, Israel

Location

Clinical Investigative Site # 5406

Tel Aviv, 64239, Israel

Location

Clinical Investigative Site # 5507

Bialystok, 15-010, Poland

Location

Clinical Investigative Site # 5505

Krakow, 31-023, Poland

Location

Clinical Investigative Site # 5501

Lodz, 90-553, Poland

Location

Clinical Investigative Site # 5502

Lublin, 20-095, Poland

Location

Clinical Investigative Site # 5503

Tarnów, 33-100, Poland

Location

Clinical Investigative Site 5610

Barnaul, 656024, Russia

Location

Clinical Investigative Site 5606

Barnaul, 656045, Russia

Location

Clinical Investigative Site 5603

Kazan', 420015, Russia

Location

Clinical Investigative Site 5602

Moscow, 105077, Russia

Location

Clinical Investigative Site 5654

Moscow, 105229, Russia

Location

Clinical Investigative Site 5607

Moscow, 115280, Russia

Location

Clinical Investigative Site 5609

Novosibirsk, 630037, Russia

Location

Clinical Investigative Site 5605

Saint Petersburg, 194044, Russia

Location

Clinical Investigative Site 5604

Saint Petersburg, 197022, Russia

Location

Clinical Investigative Site 5608

Tomsk, 634034, Russia

Location

Clinical Investigative Site 5701

Belgrade, 11080, Serbia

Location

Clinical Investigative Site 5702

Belgrade, 11080, Serbia

Location

Clinical Investigative Site 5802

Singapore, 529889, Singapore

Location

Clinical Investigative Site 5908

Bloemfontein, 9300, South Africa

Location

Clinical Investigative Site 5905

Cape Town, 7530, South Africa

Location

Clinical Ivestigative Site 5902

Cape Town, 7700, South Africa

Location

Clinical Investigative Site 5901

Durban, 4001, South Africa

Location

Clinical Investigative Site 5909

George, 6529, South Africa

Location

Clinical Investigative Site 5906

Johannesburg, 1829, South Africa

Location

Clinical Investigative Site 5910

Port Elizabeth, 6045, South Africa

Location

Clinical Investigative Site 5903

Pretoria, 0157, South Africa

Location

Clinical Investigative Site 5907

Pretoria, 0181, South Africa

Location

Clinical Investigative Site 6001

Gothenburg, 413 42, Sweden

Location

Clinical Investigative Site # 6006

Härnösand, 87182, Sweden

Location

Clinical Investigative Site 6003

Linköping, 58185, Sweden

Location

Clinical Investigative Site # 6002

Luleå, 97231, Sweden

Location

Clinical Investigative Site 6052

Lund, 22185, Sweden

Location

Clinical Investigative Site 6007

Stockholm, 111 57, Sweden

Location

Clinical Investigative Site 6004

Varberg, 432 44, Sweden

Location

Clinical Investigative Site # 6104

Donetsk, 83099, Ukraine

Location

Clinical Investigative Site 6110

Kharkiv, 61018, Ukraine

Location

Clinical Investigative Site # 6101

Kharkiv, 61035, Ukraine

Location

Clinical Investigative Site # 6102

Kyiv, 03680, Ukraine

Location

Clinical Investigative Site # 6103

Kyiv, 03680, Ukraine

Location

Clinical Ivestigative Site 6111

Odesa, 65025, Ukraine

Location

Clinical Investigative Site 6108

Poltava, 36028, Ukraine

Location

Clinical Investigative Site # 6107

Uzhhorod, 88009, Ukraine

Location

Clinical Investigative Site 6105

Zaporizhia, 69035, Ukraine

Location

Clinical Investigative Site # 6106

Zaporizhia, 69118, Ukraine

Location

MeSH Terms

Conditions

Asthma

Interventions

2-(2-(1-naphthoyl)-8-fluoro-3,4-dihydro-1H-pyrido(4,3-b)indol-5(2H)-yl)acetic acid

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sara Mangialaio, MD

  Actelion

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 21, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: July 9, 2018

Record last verified: 2018-07

Locations

AU (3); SE (7); PL (5); ZA (9); IL (7); UA (10); US (22); HU (9); RU (10); BU (4); SG (1); DE (8)