Phase 2
Completed N=159
Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma
Source: ClinicalTrials.gov NCT00425061 ↗Enrolled (actual)
159
Serious AEs
3.8%
Results posted
Jan 2015
Primary outcomePrimary: Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1 — 286.4; 297.6; 343.5; 291.5 liter per minute (L/min)
Summary
Primary purpose is to assess if IMA-638 is safe and improves asthma in subjects with persistent asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1 |
286.4; 297.6; 343.5; 291.5; 21.1; 3.4 | — |
| PRIMARY Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3 |
329.3; 348.6; 330.4; 6.8; 18.8; 7.6 | 0.612 |
| SECONDARY Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 1 |
2.1; 2.0; 2.3; 2.0; 0.1; 0.0 | — |
| SECONDARY Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 2/3 |
2.2; 2.3; 2.1; -0.0; 0.2; 0.0 | 0.482 |
| SECONDARY Change From Baseline in Airway Hyper-reactivity at Day 28 and 112 |
1.1; 0.3; 1.2; 0.6; 1.0; 0.5 | 0.090 |
| SECONDARY Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 1 |
2.7; 2.6; 2.8; 2.7; -0.6; -0.2 | — |
| SECONDARY Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 2/3 |
2.7; 2.3; 2.8; -0.6; -0.4; -0.5 | 0.354 |
| SECONDARY Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1 |
0.00; 0.00; 6.25; 12.50 | 0.267 |
| SECONDARY Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3 |
11.11; 25.00; 0.00 | 0.029 sig |
| SECONDARY Mean Number of Puffs of Rescue Medication Used - Stage 1 |
— | — |
| SECONDARY Mean Number of Puffs of Rescue Medication Used - Stage 2/3 |
— | — |
| SECONDARY Forced Vital Capacity (FVC) - Stage 1 |
— | — |
| SECONDARY Forced Vital Capacity (FVC) - Stage 2/3 |
— | — |
| SECONDARY Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 1 |
— | — |
| SECONDARY Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 2/3 |
— | — |
| SECONDARY Blood Eosinophils Levels - Stage 1 |
0.3; 0.3; 0.3; 0.3; 0.3; 0.3 | — |
| SECONDARY Blood Eosinophils Levels - Stage 2/3 |
0.3; 0.7; 0.3; 0.3; 0.7; 0.3 | — |
| SECONDARY Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 1 |
3.8; 4.5; 4.4; 4.9; 3.8; 4.3 | — |
| SECONDARY Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 2/3 |
4.5; 5.1; 4.9; 4.6; 5.1; 4.9 | — |
| SECONDARY Serum Interleukin-13 (IL-13) Level - Stage 1 |
— | — |
| SECONDARY Serum Interleukin-13 (IL-13) Level - Stage 2/3 |
— | — |
Eligibility Criteria
Inclusion Criteria
- Generally healthy men and women with persistent asthma, 18 to 70 years of age, with body weight between 50 kg and 115 kg.
- History of treatment with a medium to high dose of inhaled corticosteroids (ICS), with or without long-acting beta-agonists (LABA), for at least 2 months prior to the screening visit and must remain constant during the study.
- FEV1 ≥ 55% to ≤ 80% predicted and demonstrated improvement in FEV1 (L) with inhaled albuterol (salbutamol) (reversibility) of ≥ 12%.
Exclusion Criteria
Data sourced from ClinicalTrials.gov (NCT00425061). 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.