Study to Evaluate Handling Errors in Usage of SERETIDE® Metered Dose Inhaler (MDI) (EVOHALER®) by Adult Subjects Currently Using the SERETIDE DISKUS® Inhaler
Condition: Asthma
MeSH terms: Asthma
Intervention: SERETIDE MDI; Placebo DISKUS Inhaler; Placebo MDI
Intervention description: Commercially available SERETIDE MDI (EVOHALER) containing fluticasone propionate/salmeterol. Subjects will use MDI as 2 inhalations twice daily at the dose equivalent to their usual maintenance treatment of SERETIDE via DISKUS Inhaler.; Placebo dry powder inhaler to be used to demonstrate the use of DISKUS inhaler at Visit 1; Clear liquid propellant inhaler to be used to demonstrate the use of MDI at Visit 2
Intervention MeSH terms: Fluticasone-Salmeterol Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: EVOHALER; Asthma; SERETIDE; DISKUS Inhaler; MDI

Summary:

      This study aims to explore the potential impact of switching inhalers by assessing the
      handling error rate (critical and non-critical) in controlled asthmatics currently treated
      with, and using correctly, SERETIDE via the DISKUS Inhaler who are switched to receiving
      SERETIDE via the Metered Dose Inhaler (MDI) (EVOHALER) without training by a Healthcare
      Professional (HCP).

      This will be a descriptive, multi-centre, open-label, non randomized 14 day study assessing
      MDI technique in subjects with controlled asthma (Asthma Control Test [ACT] score >= 20 at
      Visit 1) currently treated with, and able to use correctly, SERETIDE via the DISKUS Inhaler.
      All the eligible subjects will be switched to an equivalent dose of SERETIDE via the MDI.
      Subjects will need to use the MDI inhaler in accordance the accompanying patient information
      leaflet (to be read prior to use) for approximately 14 days. No instruction, coaching or
      comment on inhaler technique will be provided by the HCP. MDI technique of subjects will be
      assessed at Visit 2 (after 14 days) and the errors will be recorded. Subject will revert back
      to using their SERETIDE DISKUS inhaler again from Visit 2. Subjects will be followed up by
      telephone for approximately 1 week after Visit 2.

      A maximum of 110 subjects will be enrolled such that approximately 100 evaluable subjects
      complete the study. The total duration of the study for each subject will be approximately 21
      days.

      SERETIDE, EVOHALER and DISKUS are registered trademarks of the GlaxoSmithKline (GSK) group of
      companies
    

Eligibility criteria:

        Inclusion Criteria:

          -  >=18 years of age at the time of informed consent.

          -  A diagnosis of asthma as defined by the National Institutes of Health, 2007.

          -  Must be currently treated with SERETIDE via the DISKUS Inhaler and have been
             maintained on this dose for 3 months prior to Visit 1.

          -  Have controlled asthma defined as a total ACT score >= 20

          -  Must be able to use their DISKUS inhaler correctly. Correct use is defined as making
             no critical errors during the assessment of DISKUS inhaler use at Visit 1.

          -  Male

          -  Female subject is eligible to participate if she is not pregnant (as confirmed by a
             negative urine human chorionic gonadotrophin [hCG] test), not lactating, and at least
             one of the following conditions applies: 1. Non-reproductive potential defined as:
             Pre-menopausal females with one of the following; documented tubal ligation,
             documented hysteroscopic tubal occlusion procedure with follow-up confirmation of
             bilateral tubal occlusion, hysterectomy, documented bilateral Oophorectomy.
             Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a
             blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels
             consistent with menopause). Females on hormone replacement therapy (HRT) and whose
             menopausal status is in doubt will be required to use one of the highly effective
             contraception methods if they wish to continue their HRT during the study. Otherwise,
             they must discontinue HRT to allow confirmation of post-menopausal status prior to
             study enrolment. 2. Reproductive potential and agrees to follow one of the options
             listed below in the GSK modified list of highly effective methods for avoiding
             pregnancy in females of reproductive potential (FRP) requirements from 30 days prior
             to the first dose of study medication and until after the last dose of study
             medication and completion of the follow-up contact.

        GSK modified list of highly effective methods for avoiding pregnancy in FRP: a.
        Contraceptive subdermal implant that meets the standard operating procedure (SOP)
        effectiveness criteria including a <1percent rate of failure per year, as stated in the
        product label. b. Intrauterine device or intrauterine system that meets the SOP
        effectiveness criteria including a <1 percent rate of failure per year, as stated in the
        product label. c. Oral Contraceptive, either combined or progestogen alone. d. Injectable
        progestogen. e. Contraceptive vaginal ring. f. Percutaneous contraceptive patches. g. Male
        partner sterilization with documentation of azoospermia prior to the female subject's entry
        into the study, and this male is the sole partner for that subject. h. Male condom combined
        with a vaginal spermicide (foam, gel, film, cream, or suppository). GSK modified list of
        highly effective methods for avoiding pregnancy in FRP does not apply to FRP with same sex
        partners, when this is their preferred and usual lifestyle or for subjects who are and will
        continue to be abstinent from penile-vaginal intercourse on a long term and persistent
        basis. These allowed methods of contraception are only effective when used consistently,
        correctly and in accordance with the product label. The investigator is responsible for
        ensuring that subjects understand how to properly use these methods of contraception.

          -  Capable of giving signed informed consent which includes compliance with the
             requirements and restrictions listed in the consent form and protocol.

        Exclusion Criteria:

          -  Have a current diagnosis of chronic obstructive pulmonary disease (COPD)

          -  Have experienced an asthma exacerbation within 3 months of Visit 1 or a lower
             respiratory tract infection within 6 weeks of Visit 1. An exacerbation is defined as
             worsening asthma requiring any treatment other than rescue salbutamol. This includes
             requiring the use of systemic or inhaled corticosteroids and /or emergency room visit
             or hospitalisation.

          -  Other Concurrent Diseases: A subject must not have any clinically significant,
             uncontrolled condition or disease state (such as severe cardiovascular disorders or
             heart rhythm abnormalities, diabetes mellitus, thyrotoxicosis, uncorrected
             hypokalaemia or predisposition to low levels of serum potassium) that, in the opinion
             of the investigator (in consultation with the GSK Medical Monitor if required), would
             put the safety of the subject at risk through study participation or would confound
             the interpretation of the results if the condition/disease exacerbated during the
             study. Please refer to the SERETIDE Product Label for a full list of conditions for
             special warnings and precautions for use.

          -  Currently taking potent Cytochrome P450 3A4 (CYP 3A4) inhibitors

          -  Currently taking beta-blockers (selective and non-selective).

          -  Allergic to salmeterol, fluticasone propionate or to norflurane (HFA 134a) or to any
             other excipients.

          -  The subject has participated in a clinical trial and has received an investigational
             product within the following time period prior to the first dosing day in the current
             study: 30 days, 5 half-lives or twice the duration of the biological effect of the
             investigational product (whichever is longer).

          -  Exposure to more than 4 investigational medicinal products within 12 months prior to
             the first dosing day.