Multi-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Teikoku Tulobuterol Tape in Adults with Bronchial Asthma

• Conditions: Bronchial Asthma (persistent)

• Registration Number: EUCTR2005-003370-15-EE
• Lead Sponsor: Teikoku Pharma USA, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Diagnosis of persistent bronchial asthma for at least 1 year prior to Visit 1, as defined by the Global Initiative for Asthma (GINA 2004);
2. Spirometric FEV1 on baseline visit should be between = 60% and = 90% of predicted normal FEV1 for age, sex, race, and height (without medication in prior 6 hours) at Visit 2;
3. Treatment with inhaled or nasal corticosteroids and/or immunotherapy that has been dose stable” for = 30 days prior to Visit 1 and will continue throughout the study;
4. Improvement in spirometric FEV1 = 12% and at least 200 mL from that day’s unmedicated FEV1 within 15-20 minutes following inhalation of two actuations of albuterol sulfate (total of 200 mcg) beta2-agonist at Visit 2;
5. Female subjects must be postmenopausal (defined as one year without menses), physically incapable of becoming pregnant, or using an acceptable birth control method. Acceptable methods of birth control include hormonal contraceptives or double-barrier methods (condom or diaphragm with spermicidal agent or IUD). If practicing an acceptable method of birth control, the subject must have confirmation of a negative urine pregnancy test at Visit 3;
6. No evidence of any chronic condition that might affect respiratory function;
7. Subject understands the procedures and has signed an informed consent form.
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Diagnosis of other airway obstruction, bronchopulmonary aspergillosis, or any form of allergic alveolitis;
2.Initiation of treatment with systemic, nasal and/or inhaled corticosteroids or immunotherapy during study;
3.Exacerbation of asthma during the screening period defined by 20% decrease in patient`s morning or evening PEF for three consecutive days on patient`s Daily Diary as determined by the investigator at the clinic visit.
4.Treatment with oral beta2-agonists, long acting beta2-agonists, theophylline, leukotriene antagonists, cromolyn sodium, nedocromil sodium, or ipratropium bromide after Visit 1;
5.Treatment with beta-blockers (including eye drops), or non-prescription asthma medication, or use of any prescription drug to which albuterol sulfate administration is contraindicated after Visit1;
6.Treatment with systemic (oral, IV, IM or rectal) corticosteroids within 30 days of Visit1;
7.Treatment with long-acting antihistamines within 10 days of Visit 2;
8.Active pulmonary disorders (other than asthma or allergies) or a respiratory infection within 3 weeks of Visit 1 or between Visit 1 and 3;
9.History of the exacerbation of asthma requiring the use of oral or parenteral corticosteroids within 3 months prior to Visit 1;
10.History of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest or hypoxic seizures at anytime prior to Visit 1;
11.Clinically significant abnormalities of serum chemistry or hematology at Visit 2;
12.History of (within the previous 10 years) any malignant or pre-malignant condition.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this clinical trial is to assess the efficacy of Teikoku Tulobuterol Tape (TTT) compared to placebo, in management of asthma symptoms in a population of adults with persistent bronchial asthma.;Secondary Objective: N/A;Primary end point(s): Change between baseline and Week 2 in the 7-day average morning peak expiratory flow (AM PEF)