Phase 2
Completed N=32
A Study of 2 Doses of MAP0010 in Adult Asthmatics
Source: ClinicalTrials.gov NCT00554970 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcomePrimary: Cmax of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg — 250; 365; 168; 197 pg/ml
Summary
The purpose of this study is to examine the blood levels of two doses of MAP0010 (a corticosteroid) and two doses of an approved corticosteroid in adult asthma and safety with twice daily dosing over 7 days.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg |
250; 365; 168; 197 | — |
| PRIMARY Cmax of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg |
528; 530; 366; 315 | — |
| PRIMARY AUC(0-inf) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg |
19400; 55900; 10300; 26900 | — |
| PRIMARY AUC(0-inf) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg |
58700; 90100; 35500; 45200 | — |
| PRIMARY Half-life (t1/2) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg |
168; 207; 112; 179 | — |
| PRIMARY Half-life (t1/2) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg |
193; 192; 248; 230 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female adult asthmatics with mild to moderate persistent asthma.
- 18 to 45 (up to the 46th birthday) years of age.
- Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH/NHLBI, EPR-3 criteria.
- Able to withhold short-acting bronchodilators (e.g., albuterol or ipratropium bromide) for at least 4 hours prior to clinic visits.
- Baseline FEV1 greater than or equal to 50% of predicted normal.
Exclusion Criteria
- Any other significant illness/abnormality
- A history of upper or lower respiratory tract infection within 2 weeks
- A history of acute or severe asthma attack requiring ICU admission or ventilatory support.
Data sourced from ClinicalTrials.gov (NCT00554970). 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.