Study of Salmeterol (SN408D) for Adult Asthma

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00950794
First received: July 30, 2009
Last updated: August 6, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Asthma
Bronchial Asthma
Drug: Salmeterol(SN408D)
Drug: Hokunalin (tulobuterol) tape
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of Salmeterol (SN408D) for Adult Asthma - Clinical Study of Salmeterol Compared With Hokunalin (Tulobuterol) Tape -

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change in morning PEF [ Time Frame: 8 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Use of short acting beta agonist [ Time Frame: 8 week ] [ Designated as safety issue: No ]
  • Adverse event [ Time Frame: 8 week ] [ Designated as safety issue: Yes ]
  • Evening PEF [ Time Frame: 8 week ] [ Designated as safety issue: No ]
  • Symptom score [ Time Frame: 8 week ] [ Designated as safety issue: No ]

Enrollment: 367
Study Start Date: September 2003
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hokunalin(tulobuterol) tape
Hokunalin(tulobuterol) tape: long-acting Beta2-agonist
Drug: Hokunalin (tulobuterol) tape
Hokunalin (tulobuterol) tape:long-acting Beta2-agonist
Experimental: Salmeterol(408DP-02)
Salmeterol(408DP-02):long-acting Beta2-agonist
Drug: Salmeterol(SN408D)
Salmeterol(SN408D):long-acting Beta2-agonist

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.
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950794

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00950794     History of Changes
Other Study ID Numbers: 112376
Study First Received: July 30, 2009
Last Updated: August 6, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Long acting beta2-agonist

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Terbutaline
Tulobuterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 22, 2014