NCT00950794CompletedPhase 4
Study of Salmeterol (SN408D) for Adult Asthma - Clinical Study of Salmeterol Compared With Hokunalin (Tulobuterol) Tape -
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 367
- Primary Endpoint
- Change in morning PEF
Study Overview
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 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.
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 (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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Subjects who have been receiving ICS 400mcg/day of FP equivalent for at least 8 weeks prior to Visit
- •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
- •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.
Arms & Interventions
Hokunalin(tulobuterol) tape
Active Comparator
Hokunalin(tulobuterol) tape: long-acting Beta2-agonist
Intervention: Hokunalin (tulobuterol) tape (Drug)
Salmeterol(408DP-02)
Experimental
Salmeterol(408DP-02)：long-acting Beta2-agonist
Intervention: Salmeterol(SN408D) (Drug)
Outcomes
Primary Outcomes
Change in morning PEF
Time Frame: 8 week
Secondary Outcomes
- Use of short acting beta agonist(8 week)
- Adverse event(8 week)
- Evening PEF(8 week)
- Symptom score(8 week)
Investigators
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