A Multi-Center, Randomized, Double-Blind, Placebo-Controlled 12-week Pilot Exploratory Study to Evaluate the Efficacy and Safety of Teikoku Tulobuterol Tape (6 mg) in Adults with Bronchial Asthma

• Conditions: Reversible airways obstruction in patients with Asthma; MedDRA version: 9.1Level: LLTClassification code 10062109Term: Reversible airways obstruction; MedDRA version: 9.1Level: LLTClassification code 10006070Term: Br. asthma

• Registration Number: EUCTR2007-004886-16-LT
• Lead Sponsor: Teikoku Pharma USA, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1.Males or females, 18 to 70 years of age.
2.Documented diagnosis of bronchial asthma for at least 6 month prior to visit 1.
3.Pre-bronchodilator FEV1 between equal or higher than 50% and equal or lower than 90% of predicted.
4.Improvement in FEV1 of equal or higher than 15% of predicted over pre-bronchodilator FEV1 within 20-30 minutes following inhalation of 200 mcg of salbutamol (Ventolin) from MDI with spacer at Visit 1.
5.Constant asthma therapy with inhaled corticosteroids for at least 4 weeks prior to Visit 1 (see chapter permitted and not permitted asthma medication).
6.Female subjects must be using an acceptable birth control method, postmenopausal (defined as one year without menses), physically incapable of becoming pregnant or complete abstinence from intercourse from first visit until one week following study completion. Acceptable methods of birth control include hormonal contraceptives or IUD (intrauterine device) or double barrier methods (condom or diaphragm with spermicidal agent). If practicing an acceptable method of birth control, the subject must have a negative urine pregnancy test at Visit 3.
7.Subject has signed and dated an informed consent form.
8.Subject is willing and able to comply with all study procedures, visit schedules, use of home twice daily lung function measurement (PiKo-1) and diaries.

Are the trial subjects under 18? no
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.Upper or lower respiratory tract infection during the last 4 weeks prior to Visit 1.
2.Asthma exacerbation during the last 4 weeks prior to Visit 1.
3.Asthma exacerbation requiring treatment with oral or systemic corticosteroids during the last 12 weeks prior to Visit 1.
4.History of life-threatening asthma at any time prior to Visit 1 defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures.
5.Treatment with oral, systemic or depot corticosteroids during the last 12 weeks prior to Visit 1.
6.Any known adverse reaction including hypersensitivity to salbutamol (Ventolin) or study product or any of its constituents.
7.Patient is undergoing allergen desensitization therapy (SIT – specific immunotherapy).
8.Chronic obstructive pulmonary disease (COPD), allergic bronchopulmonary aspergillosis, cystic fibrosis.
9.Historical or current evidence of disease which, as judged by the investigator, may put the safety of the subject at risk through study participation or may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, hepatic disease, renal disease, malignancy, hematological disease, endocrine or pulmonary disease (including, but not confined, to chronic bronchitis, bronchiectasis with no need of treatment).
10.Neurological or psychiatric disease which will interfere with subject’s ability to comply with study protocol requirements.
11.History of (within the previous 3 years) or current drug or alcohol abuse.
12.Female subjects who are pregnant or lactating.
13.Current smoker or has a smoking history more than 10 pack years.
14.Subject requires hospitalization or elective surgery is scheduled during the period of the study.
15.Subject is working at night and/or employed in shift work.
16.Previous enrollment in this study, currently participating or previous participation in another study during the last 30 days prior to Visit 1 (V1).
17.Subject is Investigator’s or sub-Investigator’s family member or is the employee of the Investigator.
18.Any condition that at the Investigator opinion would interfere with evaluation of the subject or may put the subject at undue risk.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study (pilot trial) is to compare the efficacy of 6 mg Teikoku Tulobuterol Tape (TTT) with placebo in patients with persistent bronchial asthma. ;Secondary Objective: The secondary objective of this study is to evaluate the inclusion/exclusion criteria and efficacy parameters for use in further tulobuterol development studies.<br><br>Another objective of this study is to gather safety data of TTT in the applied dosage of 6 mg per day.;Primary end point(s): Mean change from baseline (V3) up to the end of treatment period week 8 (V7) of pre-bronchodilator FEV1 (% from baseline) in clinic visit.