Study of Salmeterol (SN408D) for Adult Asthma

Study of Salmeterol (SN408D) for Adult Asthma - Clinical Study of Salmeterol Compared With Hokunalin (Tulobuterol) Tape -

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Bronchial Asthma
• Intervention / Treatment: Drug: Hokunalin (tulobuterol) tape; Drug: Salmeterol(SN408D)

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 Type: Interventional
• Enrollment (Actual): 367
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in morning PEF	8 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Use of short acting beta agonist	8 week
Adverse event	8 week
Evening PEF	8 week
Symptom score	8 week

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): February 1, 2005
• Study Completion (Actual): February 1, 2005

Study Registration Dates

• First Submitted: July 30, 2009
• First Submitted That Met QC Criteria: July 30, 2009
• First Posted (Estimate): August 3, 2009

Study Record Updates

• Last Update Posted (Estimate): August 7, 2009
• Last Update Submitted That Met QC Criteria: August 6, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Long acting beta2-agonist
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Salmeterol Xinafoate; Tulobuterol
• Other Study ID Numbers: 112376