Study of Salmeterol (SN408D) for Adult Asthma

Primary To demonstrate the efficacy (non-inferiority) of Salmeterol 50mcg bid (100mcg/day), compared with Hokunalin (tulobuterol) tape 2mg once a day, in terms of improvement in pulmonary function (peak expiratory flow: PEF) in a randomized, double-blind, parallel-group comparative study in adult patients with bronchial asthma on ICS 400mcg/day of FP equivalent.

Secondary

• To evaluate the efficacy of Salmeterol , compared with Hokunalin (tulobuterol) tape in terms of asthma symptoms recorded in the asthma diary.
• To evaluate the safety of Serevent compared with Hokunalin (tulobuterol) tape.

Inclusion criteria

• For entry into run-in period (Visit 1)

A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:

• Males or females aged >= 15 years at the time of giving informed consent.
• Subjects who are able to give a written informed consent to participation in the study.

However, if a subject is aged < 20 years at the time of giving informed consent, a written informed consent should be obtained from the subject and his/her legally acceptable representative.

• Outpatients.
• Subjects who had been diagnosed as asthma at least 6 months prior to Visit 1.
• Subjects who have been receiving ICS 400mcg/day of FP equivalent for at least 8 weeks prior to Visit 1.

• For entry into the treatment period (Visit 2)

A subject will be considered eligible for entering the treatment period only if he/she completes the run-in period and meets all of the following criteria:

• Subjects who meet both of the following criteria in terms of pulmonary function.

• Has a mean morning PEF during the last 7 days (at least 4 days) prior to Visit 2 is >= 40% of the predicted value.
• Has at least 2 days with a diurnal variation in PEF of >= 15% during the run-in period, or had been confirmed and recorded reversibility of >= 15% using rapid-acting inhaled beta2 agonists within 3 months prior to Visit 1 (including Visit 1).
• Subjects who have >= 70 % compliance with asthma medication during the run-in period.
• Subjects who were able to measure peak flows correctly during the run-in period, in the investigator's/subinvestigator's judgment.
• Subjects who were able to keep the asthma diary correctly during the run-in period, in the investigator's/subinvestigator's judgment.

Exclusion criteria

• A subject will not be eligible for inclusion in this study if any of the following criteria apply at Visit 1 or Visit 2:

• Subjects who have received injected steroids, injected ACTH, or oral steroids within four weeks of Visit1 or during run-in period.
• Subjects who have received xanthines (oral, injected, suppository), beta2 agonists other than rescue medication (rapid-acting inhaled beta2 agonists), or inhaled anti-cholinergics during the run-in period.
• Subjects with respiratory disease other than asthma (e.g., chronic bronchitis, emphysema, bronchiectasis, pulmonary fibrosis, lung cancer, sarcoidosis, and old tuberculosis) which, in the judgment of the investigator/subinvestigator, are likely to affect efficacy evaluation.
• Subjects with uncontrollable diabetes mellitus, hypertension, heart disease, or hyperthyroidism, who are inappropriate for this study in the judgement of the investigator/sub investigator.
• Subjects who are unsuitable for this study in the judgment of the investigator/subinvestigator based on 12-lead ECG findings at Visit 1.
• Subjects who are regularly using medications containing the following ingredients:

beta-blockers, alpha/beta-blockers

• Subjects who have received immunosuppressive medications excluding Tacrolimus ointment.
• Subjects who are receiving catecholamines.
• Subjects with atopic dermatitis who are inappropriate for this study in the judgment of the investigator/subinvestigator.
• Subjects who had or are suspected to have had hypersensitivity to any of the investigational products.
• Subjects who received the last dose of other investigational drugs in the past 30 days.
• Subject who are currently pregnant, possibly pregnant, lactating or willing to become pregnant during the study period.
• Subjects who consume alcohol or drugs excessively the opinion of the investigator/subinvestigator.
• Subjects who are judged by the investigator/subinvestigator to have Step 4 asthma (severe persistent), referring to "GINA2002" and "J-GL2003"．
• Subjects who are judged by the investigator/subinvestigator to be inappropriate for this study for any other reasons.