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

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Idorsia Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Asthma

Treatments

Drug: Setipiprant
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01225315
AC-060A202

Details and patient eligibility

About

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

Enrollment

438 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

438 participants in 4 patient groups, including a placebo group

Setipiprant - Dose 1
Experimental group
Description:
100 mg b.i.d.
Treatment:
Drug: Setipiprant
Setipiprant - Dose 2
Experimental group
Description:
500 mg b.i.d.
Treatment:
Drug: Setipiprant
Setipiprant - Dose 3
Experimental group
Description:
1,000 mg b.i.d
Treatment:
Drug: Setipiprant
Matching Placebo
Placebo Comparator group
Description:
Oral placebo
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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