Study to Evaluate Handling Errors in Usage of SERETIDE® Metered Dose Inhaler (MDI) (EVOHALER®) by Adult Subjects Currently Using the SERETIDE DISKUS® Inhaler
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02416180 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- SERETIDE MDI (Device); Placebo DISKUS Inhaler (Device); Placebo MDI (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Making at Least One Critical Error After the First Assessment of Metered Dose Inhaler (MDI) Technique on Day 14 |
14 | — |
| SECONDARY Percentage of Participants Making at Least One Overall Error After the First Assessment of MDI Technique on Day 14. |
41 | — |
| SECONDARY Number of Health Care Professional (HCP) Instructions Required on Day 14 |
96; 12; 2; 1 | — |
| SECONDARY Time Taken to Correctly Completing Inhaler Use at Day 14 |
1.14; 3.23; 1.25 | — |
Summary
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 condi
Data sourced from ClinicalTrials.gov (NCT02416180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.