Last updated: 11/03/2018 12:58:18

Study of salmeterol (SN408D) for adult asthma

GSK study ID
112376
Clinicaltrials.gov ID
NCT00950794
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Study of salmeterol (SN408D) for adult asthma – Clinical study of salmeterol compared with Hokunalin (tulobuterol) tape –
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change in morning PEF

Timeframe: 8 week

Secondary outcomes:

Use of short acting beta agonist

Timeframe: 8 week

Adverse event

Timeframe: 8 week

Evening PEF

Timeframe: 8 week

Symptom score

Timeframe: 8 week

Interventions:
  • Drug: Salmeterol(SN408D)
  • Drug: Hokunalin (tulobuterol) tape
    • Enrollment:
    367
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    salmeterol
    Collaborators
    Not applicable
    Study date(s)
    September 2003 to February 2005
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    15+ years
    Accepts healthy volunteers
    No
    • 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:
    • A subject will not be eligible for inclusion in this study if any of the following criteria apply at Visit 1 or Visit 2:
    • 1.Subjects who have received injected steroids, injected ACTH, or oral steroids within four weeks of Visit1 or during run-in period.
    Inclusion and exclusion criteria
    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: 1.Males or females aged >= 15 years at the time of giving informed consent. 2.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. 3.Outpatients. 4.Subjects who had been diagnosed as asthma at least 6 months prior to Visit 1. 5.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: 1.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). 2.Subjects who have >= 70 % compliance with asthma medication during the run-in period. 3.Subjects who were able to measure peak flows correctly during the run-in period, in the investigator's/subinvestigator's judgment. 4.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: 1.Subjects who have received injected steroids, injected ACTH, or oral steroids within four weeks of Visit1 or during run-in period. 2.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. 3.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. 4.Subjects with uncontrollable diabetes mellitus, hypertension, heart disease, or hyperthyroidism, who are inappropriate for this study in the judgement of the investigator/sub investigator. 5.Subjects who are unsuitable for this study in the judgment of the investigator/subinvestigator based on 12-lead ECG findings at Visit 1. 6.Subjects who are regularly using medications containing the following ingredients: beta-blockers, alpha/beta-blockers 7.Subjects who have received immunosuppressive medications excluding Tacrolimus ointment. 8.Subjects who are receiving catecholamines. 9.Subjects with atopic dermatitis who are inappropriate for this study in the judgment of the investigator/subinvestigator. 10.Subjects who had or are suspected to have had hypersensitivity to any of the investigational products. 11.Subjects who received the last dose of other investigational drugs in the past 30 days. 12.Subject who are currently pregnant, possibly pregnant, lactating or willing to become pregnant during the study period. 13.Subjects who consume alcohol or drugs excessively the opinion of the investigator/subinvestigator. 14.Subjects who are judged by the investigator/subinvestigator to have Step 4 asthma (severe persistent), referring to “GINA2002” and “J-GL2003”． 15.Subjects who are judged by the investigator/subinvestigator to be inappropriate for this study for any other reasons.
    • -

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-10-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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