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Completed

NCT Number: NCT01225315

Clinical Study to Explore the Efficacy of ACT-129968 in 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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Investigative Site 5002, Glebe, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Matching placebo administered orally twice daily

Other names: matching placebo

Setipiprant

Drug

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

Other names: ACT-129968

Primary outcomes

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

    Time frame: Baseline to week 12

Secondary outcomes

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

    Time frame: Baseline to 12 weeks

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study 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

Acronym: CONTROL

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 21, 2010
Registry last updated
Jul 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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