Acute Exacerbations of Asthma

• Conditions: Acute Exacerbations of Asthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-004749-28-Outside-EU/EEA
• Lead Sponsor: Banyu Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-03
• Last Update Posted: 13 April 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

Age: between 15 and 75 years of age.
Gender: irrelevant
All females must demonstrate a urine ?-hCG level consistent with the nongravid state (it’s not necessary if 3 years have passed since the onset of menopause, and if pregnancy is organically impossible).Patient has at least a 1 year history of asthma.
Patient understands the study procedures and agrees to participate as indicated by signing the appropriate informed consent.
All females must demonstrate a urine ?-hCG level consistent with the nongravid state prior to random allocation. Patient is admitted to the study site because of an acute exacerbation of asthma. Patient has a forced expiratory volume in 1 second (FEV1) of < 70% of the predicted value at each evaluation. Patient is able to perform reproducible pulmonary tests (spirometry) as described Protocol. Patient agrees to administration of study drug as indicated by signing the confirmation slip.

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31

Exclusion Criteria

Patient has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., COPD, chronic heart failure, etc.).
The patient’s asthma has lifethreatening features, including, but not limited to, immediate respiratory failure, the need for intubation, evidence of a pneumothorax or pneumomediastinum.
The patient is febrile (temperature >38.0°C) OR has signs or symptoms of pneumonia in Screening period.
The time in Screening period (between initiation of first ?-agonist nebulization after study site admission and study drug administration) exceeds 60 minutes..
The percent predicted FEV1 value has increased or decreased by 20 percentage points between 2 measurements during Screening period.
Patient has FEV1 of <30% of the predicted value or Spo2 <90% during Screening period.
Patient has any comorbid disorder that would require therapy during Screening period and Treatment period.
Patient has received any dose of corticosteroids (other than their usual dose and other than percutaneous, eye drop, and nasal drops) within 6 hours of starting Screening period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To estimate the improvement in FEV1 of intravenous (IV) MK-476 7 mg, 14 mg and Aminophylline IV drip in patient with acute asthma.<br>To examine the safety and tolerability of MK-476 7 mg, 14 mg IV and Aminophylline IV drip.<br>;Secondary Objective: Not applicable;Primary end point(s): The time weighted average change in FEV1 from preallocation baseline over the first 60 minutes from the point of 5minutes after beginning of study drug administration [average ? FEV1 (0-60 min)]. ;Timepoint(s) of evaluation of this end point: FEV1 (0-60 min)

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: FEV1 (0-60 min) ;Secondary end point(s): The time weighted average percent change in FEV1 from preallocation baseline over the first 60 minutes from the point of 5minutes after beginning of study drug administration [average % ? FEV1 (0-60 min)].<br>The time weighted average change and percent change in FEV1 from preallocation baseline over the first 120, 90, 40, 20 minutes from the point of 5minutes after beginning of study drug administration.<br>The change and the percent change in FEV1 from preallocation baseline at 10, 20, 40, 60, 90, and 120 minutes from the point of 5minutes after beginning of study drug administration.<br>The percentage of patients having received corticosteroids.<br>The total number of doses of ß-agonist per patient.<br>Patient’s global evaluation.<br>Investigator’s global evaluation. <br>