Status:
COMPLETED
Study of Salmeterol (SN408D) for Adult Asthma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Bronchial Asthma
Eligibility:
All Genders
15+ years
Phase:
PHASE4
Brief Summary
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 expir...
Detailed Description
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 (pe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
367 Patients enrolled
Trial Details
Trial ID
NCT00950794
Start Date
September 1 2003
End Date
February 1 2005
Last Update
August 7 2009
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