Phase 2
Completed N=309
A Study of Safety and Efficacy of CNTO 148 in Patients With Severe Persistent Asthma
Source: ClinicalTrials.gov NCT00207740 ↗Enrolled (actual)
309
Serious AEs
27.8%
Results posted
Jun 2012
Primary outcomePrimary: Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second — 2.44; 0.48; 3.22; 2.59 Percent predicted — p=0.802
Summary
The purpose of this study is to evaluate the effectiveness and safety of CNTO 148 (golimumab) in patients with severe persistent asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second |
2.44; 0.48; 3.22; 2.59; 2.91 | 0.802 |
| PRIMARY Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months |
0.5; 0.7; 0.4; 0.5; 0.5 | 0.718 |
| SECONDARY Change From Baseline in Asthma Quality of Life Questionnaire Score at 6 Months; Randomized Patients |
0.42; 0.53; 0.86; 0.55; 0.66 | 0.286 |
| SECONDARY Change From Baseline in Rescue Medication Use at 6 Months; Randomized Patients |
-0.54; -0.71; -0.29; -0.14; -0.21 | 0.894 |
| SECONDARY Number of Severe Asthma Exacerbations Per Patient From Week 24 Through Week 52; Randomized Patients Who Did Not Discontinue Study Participation Prior to Week 24 |
0.6; 0.8; 0.9; 0.8; 0.9 | 0.273 |
| SECONDARY Change From Baseline in Oral Corticosteroids Dose at Week 52; Randomized Patients Who Received Oral Corticosteroids at Baseline |
-5.000; 0.000; -4.550; -3.750; -4.550 | 0.986 |
| SECONDARY Change From Baseline in Domiciliary Morning Peak Expiratory Flow Rate (PEFR) at 6 Months; Randomized Subjects |
4.730; 8.102; 3.488; 2.475; 2.975 | 0.833 |
Eligibility Criteria
Inclusion Criteria
- Physician diagnosis of asthma for greater than or equal to 3 years and a diagnosis of severe persistent asthma forgreater than or equal to 1 year prior to screening
- Continuous treatment with high dose Inhaled corticosteroids (ICS) and long acting beta-agonist for at least 3 months prior to screening
- Have evidence of at least 1 of the following in the 5 years prior to screening or during screening, reversible airway obstruction greater than or equal to 12 percentage change in forced expiratory volume in 1 second (FEV1) postbronchodilator; Diurnal variation in peak expiratory flow rate (PEFR) greater than or equal to 30 percentage change) and airway hyperresponsiveness
- Estimated frequency of symptoms on more than one-third of days for at least 3 months prior to screening (eg, wheezing, breathlessness, chest tightness, cough, nocturnal awakening) despite treatment with high dose ICS and long-acting β2-agonist (LABA), with or without continuous oral corticosteroids
- Score of greater than or equal to 2 points on the asthma control questionnaire at screening.
Exclusion Criteria
- Diagnosis of chronic obstructive pulmoanry disease (COPD), cystic fibrosis, or other significant respiratory disorder
- Worsening of asthma symptoms that required treatment with an addition or increase in oral corticosteroids dose (steroid burst) in the 4-week period prior to the screening visit
- Life-threatening asthma attack requiring cardiopulmonary support (eg, intubation) in the 6-month period prior to screening
- Have ever used alkylating agents (eg, chlorambucil or cyclophosphamide)
- Concomitant diagnosis or any history of congestive heart failure (CHF), including medically controlled CHF.
Data sourced from ClinicalTrials.gov (NCT00207740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.