A Study Investigating the Tolerability and Pharmacokinetics of Submicron Budesonide in Children 4 Through 11 Years Old With a History of Mild-To-Moderate Stable Asthma
This study has been completed.
Sponsor:
MAP Pharmaceuticals, Inc.
Information provided by:
MAP Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00995904
First received: October 6, 2009
Last updated: November 25, 2009
Last verified: November 2009
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Purpose
This Phase 2 study will investigate the tolerability of submicron budesonide at three doses in volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery. This study is designed to evaluate the systemic exposure of a new submicron budesonide formulation in a next generation nebulizer.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: submicron budesonide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-Label, 3-Dose, 3-Period, Crossover Phase 2 Study Investigating the Tolerability and Pharmacokinetics of MAP0010 in Children 4 Through 11 Years Old With a History of Mild-To-Moderate Stable Asthma |
Resource links provided by NLM:
Further study details as provided by MAP Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Evaluate the pharmacokinetic profile of submicron budesonide resulting from inhalation aerosol delivery. The following pharmacokinetic parameters computed include Cmax, tmax, AUC0-last, AUC0-12, AUC1-inf, CL, kel, t ½, λ, and relative bioavailability. [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluate the safety and tolerability (adverse events) of a single dose of submicron budesonide via inhalation aerosol delivery. [ Time Frame: 2-4 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 24 |
| Study Start Date: | September 2009 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: submicron budesonide |
Drug: submicron budesonide
inhalation suspension
|
Eligibility| Ages Eligible for Study: | 4 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female children with a documented diagnosis of mild-to-moderate persistent asthma (according to the 2007 NIH [EPR] criteria) for at least 1 year prior to screening and medically stable for a minimum of 6 months prior to screening.
- Children 4 through 11 years old (up to one day prior to their 12th birthday at randomization).
Contacts and Locations More Information
No publications provided
| Responsible Party: | VP Clinical Development and Medical Affairs, MAP Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00995904 History of Changes |
| Other Study ID Numbers: | MAP0020-CL-P201 |
| Study First Received: | October 6, 2009 |
| Last Updated: | November 25, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by MAP Pharmaceuticals, Inc.:
|
asthmatic children |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 18, 2013