Safety and Efficacy of QAW039 in Sputum Eosinophilia and Persistent Asthma

NCT ID: NCT01545726

Last Updated: 2013-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-06-30

Brief Summary

This study will assess the safety and efficacy of QAW039 when added to current therapy in patients that have sputum eosinophilia and persistent asthma.

Conditions

Asthma

Keywords

Asthma; Sputum eosinophilia; CRTH2 receptor; PGD2 antagonist

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

QAW039

Eligible patients will receive QAW039 po 450 mg daily dose.

Group Type: EXPERIMENTAL

QAW039

Intervention Type: DRUG

QAW039 was supplied as capsules for oral administration.

Placebo

Placebo to QAW039 (oral capsules) will be administered to match QAW039 schedule.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo was supplied as capsules for oral administration.

Interventions

QAW039

QAW039 was supplied as capsules for oral administration.

Intervention Type: DRUG

Placebo

Placebo was supplied as capsules for oral administration.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed.

2. Physician diagnosis of asthma, as per GINA guidelines GINA guidelines and currently prescribed ICS or ICS-LABA therapy.

3. Patients who are demonstrated to have reversible airway obstruction, significant FEV1 variability or airway hyperresponsiveness (AHR), or who have shown such responses in previous test(s) within the last five years.

4. An ACQ score ≥ 1.5 at randomization or ≥ 1 exacerbations (requiring higher than the patient's normal dose of OCS or IV corticosteroids for ≥ 3 days) in the past 12 months. The definition of exacerbations includes episodes during which the patient self-administered higher doses of OCS as part of a documented self-management plan initiated by the patient's general practitioner or respiratory physician.

5. Patients currently on GINA step 2 to step 5 asthma therapies.

6. Sputum eosinophil count ≥ 2% at screening.

Exclusion Criteria

1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.

2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (CRTH2 antagonists).

3. History of long QT syndrome or whose QTc interval (Fridericia's) is prolonged >450 msec for males and >470 msec for females at screening or baseline.

4. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.

5. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).

6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the study treatment and for 5 days (5 half-lives) after treatment.

7. Acute illness other than asthma which, in the investigator's opinion, may compromise the well-being of the patient or study endpoint assessments at the start of the study

8. Patients who are considered unsuitable for inclusion by the assessing physician due to serious co-morbidities such as cancer, emphysema or significant bronchiectasis.

9. Recent (within 6 weeks of screening) or current lower respiratory tract infection.

10. Patients who have been hospitalized or required high-dose (>10mg prednisolone/day) oral corticosteroid (OCS) therapy within 6 weeks of the screening visit.

11. Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening.

12. Patients who have a clinically significant abnormality on a 12-lead ECG recorded within one month prior to or at screening.

13. Patients with a body mass index (BMI) < 17 or > 40 kg/m2.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Leicester, , United Kingdom

Countries

United Kingdom

References

Gonem S, Berair R, Singapuri A, Hartley R, Laurencin MFM, Bacher G, Holzhauer B, Bourne M, Mistry V, Pavord ID, Mansur AH, Wardlaw AJ, Siddiqui SH, Kay RA, Brightling CE. Fevipiprant, a prostaglandin D2 receptor 2 antagonist, in patients with persistent eosinophilic asthma: a single-centre, randomised, double-blind, parallel-group, placebo-controlled trial. Lancet Respir Med. 2016 Sep;4(9):699-707. doi: 10.1016/S2213-2600(16)30179-5. Epub 2016 Aug 5.

Reference Type: DERIVED

PMID: 27503237 (View on PubMed)

Other Identifiers

2011-004966-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQAW039A2208

Identifier Type: -

Identifier Source: org_study_id