AsthmaPhase 2CONTROLNCT01225315
Clinical Study to Explore the Efficacy of ACT-129968 in Patients With Partly Controlled Asthma
A Phase 2 study testing Setipiprant in people with Asthma, run by Idorsia Pharmaceuticals Ltd. at 97 sites in 13 countries.
Trial summary
This study will assess the efficacy and safety of ACT-129968 in subjects with partly controlled asthma on reliever therapy only. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Setipiprant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 438 participants
- Where
- 97 sitesin 13 countries
- Study dates
- 1 Nov 2010to 1 Feb 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
97 sites in 13 countries.
97 sites in 13 countries
United States22 sites
Clinical Investigative Site # 6220
El Paso, Texas, 79903
Clinical Investigative Site # 6225
Fort Worth, Texas, 76132
Clinical Investigative Site # 6228
Greenville, South Carolina, 29615
Clinical Investigative Site 6202
Knoxville, Tennessee, 37909
Clinical Inverstigative Site #6201
Lake Oswego, Oregon, 97035
Clinical Investigative Site # 6204
Los Angeles, California, 90025
Clinical Investigative Site 6208
Los Angeles, California, 90095
Clinical Investigative Site # 6217
Madison, Wisconsin, 53792
Clinical Investigative Site # 6207
Medford, Oregon, 97504
Clinical Investigative Site 6226
Nashville, Tennessee, 37208
Clinical Investigative Site # 6215
New Orleans, Louisiana, 70112
Clinical Investigative Site 6213
Normal, Illinois, 61761
Clinical Investigative Site # 6211
North Dartmouth, Massachusetts, 02747
Clinical Investigative Site 6203
Philadelphia, Pennsylvania, 19107
Clinical Investigative Site # 6214
Portland, Oregon, 97213
Clinical Investigative Site # 6222
San Antonio, Texas, 78229
Clinical Investigative Site 6229
San Antonio, Texas, 78229
Clinical Investigative Site 6230
Spartanburg, South Carolina, 29303
Clinical Investigative Site # 6209
St Louis, Missouri, 63141
Clinical Investigative Site # 6219
Tallahassee, Florida, 32308
Clinical Investigative Site 6205
The Bronx, New York, 10461
Clinical Investigative Site # 6223
Winston-Salem, North Carolina, 27157
Russia10 sites
Clinical Investigative Site 5610
Barnaul, 656024
Clinical Investigative Site 5606
Barnaul, 656045
Clinical Investigative Site 5603
Kazan', 420015
Clinical Investigative Site 5602
Moscow, 105077
Clinical Investigative Site 5654
Moscow, 105229
Clinical Investigative Site 5607
Moscow, 115280
Clinical Investigative Site 5609
Novosibirsk, 630037
Clinical Investigative Site 5605
Saint Petersburg, 194044
Clinical Investigative Site 5604
Saint Petersburg, 197022
Clinical Investigative Site 5608
Tomsk, 634034
Ukraine10 sites
Clinical Investigative Site # 6104
Donetsk, 83099
Clinical Investigative Site 6110
Kharkiv, 61018
Clinical Investigative Site # 6101
Kharkiv, 61035
Clinical Investigative Site # 6102
Kyiv, 03680
Clinical Investigative Site # 6103
Kyiv, 03680
Clinical Ivestigative Site 6111
Odesa, 65025
Clinical Investigative Site 6108
Poltava, 36028
Clinical Investigative Site # 6107
Uzhhorod, 88009
Clinical Investigative Site 6105
Zaporizhia, 69035
Clinical Investigative Site # 6106
Zaporizhia, 69118
Hungary9 sites
Clinical Investigative Site 5310
Budapest, 1036
Clinical Investigative Site 5307
Csorna, 9300
Clinical Investigative Site 5304
Miskolc, 3529
Clinical Investigative Site # 5303
Nyíregyháza, 4400
Clinical Investigative Site 5309
Sátoraljaújhely, 3980
Clinical Investigative Site 5301
Siófok, 8600
Clinical Investigative Site # 5308
Sopron, 9400
Clinical Investigative Site # 5305
Szombathely, H-9700
Clinical Investigative Site 5302
Tatabánya, H-2800
South Africa9 sites
Clinical Investigative Site 5908
Bloemfontein, 9300
Clinical Investigative Site 5905
Cape Town, 7530
Clinical Ivestigative Site 5902
Cape Town, 7700
Clinical Investigative Site 5901
Durban, 4001
Clinical Investigative Site 5909
George, 6529
Clinical Investigative Site 5906
Johannesburg, 1829
Clinical Investigative Site 5910
Port Elizabeth, 6045
Clinical Investigative Site 5903
Pretoria, 0157
Clinical Investigative Site 5907
Pretoria, 0181
Germany8 sites
Clinical Investigative Site 5208
Berlin, 10969
Clinical Investigative Site 5212
Berlin, 12165
Clinical Investigative Site 5205
Dortmund, 44263
Clinical Investigative Site 5207
Gelnhausen, 63571
Clinical Investigative Site 5211
Hamburg, 20357
Clinical Investigative 5209
Lübeck, 23552
Clinical Investigative Site 5204
Mainz, 55116
Clinical Investigative Site 5202
Rüdersdorf, 15562
Israel7 sites
Clinical Investigative Site # 5407
Ashkelon, 78278
Clinical Investigative Site 5401
Haifa, 34362
Clinical Investigative Site # 5402
Jerusalem, 91120
Clinical Investigative Site 5405
Petach Tikvah, 49100
Clinical Investigative Site # 5403
Rehovot, 76100
Clinical Investigative Site # 5404
Tel Aviv, 64239
Clinical Investigative Site # 5406
Tel Aviv, 64239
Sweden7 sites
Clinical Investigative Site 6001
Gothenburg, 413 42
Clinical Investigative Site # 6006
Härnösand, 87182
Clinical Investigative Site 6003
Linköping, 58185
Clinical Investigative Site # 6002
Luleå, 97231
Clinical Investigative Site 6052
Lund, 22185
Clinical Investigative Site 6007
Stockholm, 111 57
Clinical Investigative Site 6004
Varberg, 432 44
Poland5 sites
Clinical Investigative Site # 5507
Bialystok, 15-010
Clinical Investigative Site # 5505
Krakow, 31-023
Clinical Investigative Site # 5501
Lodz, 90-553
Clinical Investigative Site # 5502
Lublin, 20-095
Clinical Investigative Site # 5503
Tarnów, 33-100
Bulgaria4 sites
Clinical Investigative Site # 5103
Rousse, 7002
Clinical Investigative Site # 5101
Sofia, 1431
Clinical Investigative Site # 5104
Sofia, 1431
Clinical Investigative Site # 5102
Stara Zagora, 6003
Australia3 sites
Clinical Investigative Site 5002
Glebe, 2037
Clinical Investigative Site 5003
Nedlands, 6009
Clinical Investigative Site 5001
Sherwood, 4075
Serbia2 sites
Clinical Investigative Site 5701
Belgrade, 11080
Clinical Investigative Site 5702
Belgrade, 11080
About this study
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
This study will assess the efficacy and safety of ACT-129968 in subjects with partly controlled asthma on reliever therapy only.
- Conditions
- Asthma
- Being tested
- Placebo, Setipiprant
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called matching placebo
Matching placebo administered orally twice daily
SetipiprantDrug
Also called ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Setipiprant - Dose 1 | Experimental | 100 mg b.i.d. Receives: Drug: Setipiprant |
| Setipiprant - Dose 2 | Experimental | 500 mg b.i.d. Receives: Drug: Setipiprant |
| Setipiprant - Dose 3 | Experimental | 1,000 mg b.i.d Receives: Drug: Setipiprant |
| Matching Placebo | Placebo comparator | Oral placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo
Measured: Baseline to week 12
Secondary outcomes (1)
Explore the efficacy of different doses of ACT-129968 on change in lung function and asthma control
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study start1 Nov 2010
- Primary completion1 Jan 2012
- Study completion1 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sara Mangialaio, MD, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225315
- Sponsor's protocol ID
- AC-060A202
- Acronym
- CONTROL
- Status last verified
- Jul 2018
- First submitted
- 19 Oct 2010
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01225315
- Acronym / sponsor ID
- CONTROL / AC-060A202
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2010
- Primary completion
- 1 Jan 2012 (actual)
- Study completion
- 1 Feb 2012 (actual)
- First posted
- 21 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy and safety of ACT-129968 in subjects with partly controlled asthma on reliever therapy only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Setipiprant - Dose 1 | Experimental | Drug: Setipiprant100 mg b.i.d. |
| Setipiprant - Dose 2 | Experimental | Drug: Setipiprant500 mg b.i.d. |
| Setipiprant - Dose 3 | Experimental | Drug: Setipiprant1,000 mg b.i.d |
| Matching Placebo | Placebo comparator | Drug: PlaceboOral placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: matching placeboMatching placebo administered orally twice daily | Drug | Matching Placebo |
| SetipiprantAlso: ACT-129968ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily | Drug | Setipiprant - Dose 1, Setipiprant - Dose 2, Setipiprant - Dose 3 |
Primary outcome
To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo
Time frame: Baseline to week 12
1 secondary outcome
Explore the efficacy of different doses of ACT-129968 on change in lung function and asthma control
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Mangialaio, MD study director
Actelion
97 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Setipiprant in people with Asthma, run by Idorsia Pharmaceuticals Ltd. at 97 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 97 sites in United States, Russia, Ukraine, Hungary, South Africa and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo (time frame: Baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.