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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01225315

Acronym

CONTROL

Enrollment

438

Registered

2010-10-21

Start date

2010-11-01

Completion date

2012-02-01

Last updated

2018-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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

Interventions

DRUGPlacebo

Matching placebo administered orally twice daily

DRUGSetipiprant

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo	Baseline to week 12

Secondary

Measure	Time frame
Explore the efficacy of different doses of ACT-129968 on change in lung function and asthma control	Baseline to 12 weeks

Countries

Australia, Bulgaria, Germany, Hungary, Israel, Poland, Russia, Serbia, Singapore, South Africa, Sweden, Ukraine, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026