A Multi-Center, Randomized, Double-Blind, Placebo-Controlled study to investigate the efficacy and safety of 52 weeks treatment with QGE031 s.c. in Asthma Patients not adequately controlled by medium- or high-dose ICS plus LABA with or without OCS

Phase 2

Completed

Conditions: asthma
N/A
10006436

Registration Number: NL-OMON42235

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 38

Inclusion Criteria

- Male and female adult patients aged * 18 to * 75 years.
- Patients with a diagnosis of asthma according to GINA 2014 for a period of at least 12 months prior to Visit 1.
- Daily treatment with medium- or high-dose ICS plus LABA (b.i.d. or equivalent) for * 3 months prior to Visit 1 (stable regimen at least 4 weeks prior to Visit 1). If the patients are treated with OCS (* 10 mg/day of prednisone or equivalent), the regimen should be stable at least 4 weeks prior to Visit 1 (Appendix 3 for the definition of corticosteroid dose).
- A documented history of at least two asthma exacerbations in the 12 months prior to Visit 1 that had required treatment with systemic corticosteroids (SCS) for at least 3 continuous days or a depo-injectable corticosteroids, or that required hospitalization or ER visit.
- FEV1 of * 40% and * 80% of the predicted normal value for the patient, after withholding bronchodilators at Visit 101. Withholding period of bronchodilators prior to spirometry: SABA for * 6 hrs and LABA (or FDC of ICS/LABA) for * 24 hrs, SAMA for * 8 hrs, LAMA for * 24 hrs. If FEV1 is between * 35 to 40% or 80 to * 85% of the patient*s predicted normal value, a one-time re-testing is allowed. Re-assessment of % predicted FEV1 should be done in an ad-hoc visit to be scheduled on a date that would provide sufficient time to receive confirmation from the spirometry data central reviewer before randomization.
- Patients must demonstrate an increase in FEV1 of * 12% and 200 mL within 30 minutes after administration of 400 µg salbutamol/albuterol (or equivalent dose) at Visit 1.
If reversibility is not proven at Visit 101, patients may be permitted to enter the study with historical evidence of reversibility within 5 years prior to Visit 1.
- Body mass index (BMI) must be within the range of * 18 and * 45 kg/m2.
- Asthma which is not adequately controlled on current treatment, as demonstrated by an ACQ5 score of *1.5 at Visit 101 and at Visit 102.
- The atopic status will be assessed at Visit 1 by using *Skin Prick Test (SPT)* and blood multi-allergen testing (ImmunoCAP Phadiatop, Phadia AB)* during V1.

Exclusion Criteria

- Patients who experience an asthma attack/exacerbation requiring a short burst of SCSs during screening and run-in, they may be rescreened 6 weeks after recovery from the attack/exacerbation
- Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
- Patients who experience a respiratory tract infection during screening and run-in, they may be rescreened 4 weeks after recovery from the respiratory tract infection
- History of life-threatening asthma in the previous ten years, including a history of significant hypercarbia (pCO2 > 45 mmHg), prior intubation (endotracheal and NIPPV), respiratory arrest, or seizures as a result of asthma
- Patients who have smoked or inhaled tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years (e.g. 10 pack years = 1 pack/day x 10 years or * pack/day x 20 years, etc.).
- Patients who are participating in the active phase of a supervised pulmonary rehabilitation program unless the patient is on a maintenance program that has been ongoing for at least 3 months.
- Patients who have not achieved acceptable spirometry results at Visit 101 in accordance with ATS/ERS criteria for acceptability and repeatability (rescreening allowed only once).
- Patients with chronic lung diseases other than asthma.
- History of generalized urticaria or who have an acute urticaria episode at time of screening or during run-in. If patients experience an acute urticaria episode during screening or run-in, they may be rescreened after recovery from the urticaria.
- Patients with a stool examination positive for ova/parasites at Visit 101. If a stool test is positive for Blastocystis hominis (a non-pathogenic parasite) and the patient is asymptomatic, the patient can continue the study without screening failure.