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AsthmaPhase 4NCT00950794

Study of Salmeterol (SN408D) for Adult Asthma

A Phase 4 study testing Salmeterol(SN408D) and Hokunalin (tulobuterol) tape in people with Asthma and Bronchial Asthma, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Asthma, Bronchial Asthma
What is being tested?
Salmeterol(SN408D) and Hokunalin (tulobuterol) tape
Could I receive a placebo?
No, everyone receives an active treatment
How many people
367 participants
Where
No sites listed yet
Study dates
Sep 2003to Feb 2005
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

About this study

Official title: 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.

Read the 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.
Being tested
Salmeterol(SN408D), Hokunalin (tulobuterol) tape
Keywords
Long acting beta2-agonist
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Salmeterol(SN408D)Drug

    Salmeterol(SN408D)：long-acting Beta2-agonist

  • Hokunalin (tulobuterol) tapeDrug

    Hokunalin (tulobuterol) tape:long-acting Beta2-agonist

Study groups in NCT00950794
Study groupRoleWhat they receive
Hokunalin(tulobuterol) tapeActive comparatorHokunalin(tulobuterol) tape: long-acting Beta2-agonist
Receives: Drug: Hokunalin (tulobuterol) tape
Salmeterol(408DP-02)ExperimentalSalmeterol(408DP-02)：long-acting Beta2-agonist
Receives: Drug: Salmeterol(SN408D)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in morning PEF

    Measured: 8 week

Secondary outcomes (4)

  1. Use of short acting beta agonist

    Measured: 8 week

  2. Adverse event

    Measured: 8 week

  3. Evening PEF

    Measured: 8 week

  4. Symptom score

    Measured: 8 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2009 (estimated)
  2. Study startSep 2003
  3. Primary completionFeb 2005
  4. Study completionFeb 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
367 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00950794
Sponsor's protocol ID
112376
Status last verified
Aug 2009
First submitted
30 Jul 2009
Last updated
7 Aug 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Salmeterol(SN408D) and Hokunalin (tulobuterol) tape in people with Asthma and Bronchial Asthma, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in morning PEF (time frame: 8 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00950794.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2009.

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