ELLIPTA™ vs. MDI Inhaler Preference Study, in Adult Subjects With Asthma
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | June 2014 |
End Date: | July 2014 |
A Preference Study of Inhaler Attributes Between Two Inhalers; ELLIPTA and MDI, in Adult Subjects With Asthma
This is a multicenter, stratified, and randomized, open-label, placebo study in subjects
with asthma to compare inhalers, ELLIPTA a new dry powder inhaler (DPI) and metered dose
inhalers (MDI). This study is conducted to evaluate subject's preference of several
inhaler-specific attributes individually between an existing MDI and the ELLIPTA a dry
powder inhaler. Subjects who have not used the ELLIPTA inhaler in the past 6 months and
their asthma must be controlled on their current therapy were enrolled. Subjects meeting the
eligibility criteria will be stratified according to their current inhaler use (stable for
the past 3 months): 1.) Currently using a DPI as an inhaled asthma controller therapy OR 2.)
Currently using an MDI as an inhaled asthma controller therapy (No fluticasone MDI use in
the last 3 months) OR 3.) Currently using no inhaled asthma controller therapy (this
includes patients using a LTM and/or SABA only). Once stratified, eligible subjects were
randomized (1:1) to one of two sequences for using the inhaler: ELLIPTA inhaler once daily
in Period 1 followed by MDI twice daily in Period 2 or MDI twice daily in Period 1 followed
by ELLIPTA inhaler once daily in Period 2 for for 5-9 days each. In addition, subjects will
be randomly assigned (1:1 allocation) to receive one of two sets of questions: Version 1
presents response options in the order of ELLIPTA inhaler, MDI, No preference; Version 2
presents response options in the order of MDI, ELLIPTA inhaler, No preference. At the end of
the second trial period, subjects answered questions which assessed their preference of
inhaler attributes. ELLIPTA is a registered trademark of the GSK group of companies.
with asthma to compare inhalers, ELLIPTA a new dry powder inhaler (DPI) and metered dose
inhalers (MDI). This study is conducted to evaluate subject's preference of several
inhaler-specific attributes individually between an existing MDI and the ELLIPTA a dry
powder inhaler. Subjects who have not used the ELLIPTA inhaler in the past 6 months and
their asthma must be controlled on their current therapy were enrolled. Subjects meeting the
eligibility criteria will be stratified according to their current inhaler use (stable for
the past 3 months): 1.) Currently using a DPI as an inhaled asthma controller therapy OR 2.)
Currently using an MDI as an inhaled asthma controller therapy (No fluticasone MDI use in
the last 3 months) OR 3.) Currently using no inhaled asthma controller therapy (this
includes patients using a LTM and/or SABA only). Once stratified, eligible subjects were
randomized (1:1) to one of two sequences for using the inhaler: ELLIPTA inhaler once daily
in Period 1 followed by MDI twice daily in Period 2 or MDI twice daily in Period 1 followed
by ELLIPTA inhaler once daily in Period 2 for for 5-9 days each. In addition, subjects will
be randomly assigned (1:1 allocation) to receive one of two sets of questions: Version 1
presents response options in the order of ELLIPTA inhaler, MDI, No preference; Version 2
presents response options in the order of MDI, ELLIPTA inhaler, No preference. At the end of
the second trial period, subjects answered questions which assessed their preference of
inhaler attributes. ELLIPTA is a registered trademark of the GSK group of companies.
Inclusion Criteria:
- Informed consent: Subject must give their signed and dated written informed consent
to participate; Subject understands and is willing, able, and likely to comply with
study procedures and restrictions; Subject must be able to read, comprehend, and
record information in English.
- Age: >=18 years of age at Visit 1
- Gender: Male or non-pregnant female subjects. Female subjects must not be pregnant at
the time of Visit 1 based on the investigator's evaluation during medical history and
physician examination.
- Asthma Diagnosis: Asthma as defined by the National Institutes of Health
- Reversibility of Disease: Demonstrated historical reversibility of >=12% and >=200
milliliter (mL) reversibility of forced expiratory volume in one second (FEV1) within
10-40 minutes following 2-4 inhalations of albuterol/salbutamol inhalation aerosol
(or equivalent nebulized treatment with albuterol/salbutamol solution) within 24
months of Visit 1.
- Ability to use Inhalers: Subjects must demonstrate the ability to correctly use the
ELLIPTA and MDI inhalers.
- Current asthma therapy: Subjects must be using one of the following three stable
asthma therapies for at least 3 months prior to screening: a. Currently using a DPI
as an inhaled asthma controller therapy; OR b. Currently using an MDI as an inhaled
asthma controller therapy (No fluticasone MDI use in the last 3 months); OR c.
Currently using no inhaled asthma controller therapy (this includes patients using a
leukotriene modifiers (LTM) and/or short-acting beta2-agonists (SABA) as rescue
only). All subjects will be allowed the concomitant use of their currently prescribed
asthma treatment(s) throughout the study, including rescue albuterol MDI (SABA) as
needed.
Exclusion Criteria
- Pregnant: Women who are pregnant or lactating.
- MDI daily controller therapy: Subjects using Fluticatsone propionate (fluticasone
HFA) MDI during the last 3 months.
- ELLIPTA USE: Subjects who used any ELLIPTA inhaler (e.g., participated in a clinical
study of fluticasone furoate (FF) or FF/vilanterol (VI) or any component of them, or
placebo) within 6 months (i.e., 180 days) prior to Visit 1.
- Asthma Control: Subjects who in the investigator's judgment have poorly controlled or
have unstable asthma.
- Chronic Obstructive Pulmonary Disease (COPD): Subjects with a current primary
diagnosis of COPD.
- History of Life-threatening asthma: Defined for this protocol as an asthma episode
that required intubation and/or was associated with hypercapnea, respiratory arrest
or hypoxic seizures.
- Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 1
month of Visit 1. A subject must not have had any hospitalization for asthma within 3
months prior to Visit 1.
- Concurrent Diseases/Abnormalities: Historical or current evidence of clinically
significant uncontrolled disease including, but not limited to: cardiovascular
disease, hepatic disease, renal disease, hematological disease, neurological disease,
or pulmonary disease (including, but not confined to chronic bronchitis, emphysema,
bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary
dysplasia, and chronic obstructive pulmonary disease). Significant is defined as any
disease that, in the opinion of the investigator, would put the safety of the subject
at risk through participation, or which would affect the efficacy or safety analysis
if the disease/condition exacerbated during the study.
- Oropharyngeal Examination: A subject will not be eligible for the study if he/she has
clinical visual evidence of oral candidiasis at Visit 1.
- Investigational Medications: A subject must not have used any investigational drug
within 30 days prior to Visit 1.
- Drug Allergy: Known or suspected sensitivity to the constituents of the placebo dry
powder inhaler or MDI (i.e. lactose or magnesium stearate).
- Milk Protein Allergy: History of severe milk protein allergy.
- Tobacco Use. Current smoker or a smoking history of 10 pack years or more (e.g. 20
cigarettes/day for 10 years)
- Affiliation with Investigator's Site: A subject will not be eligible for this study
if he/she is an immediate family member of the participating Investigator,
sub-Investigator, study coordinator, or employee of the participating Investigator.
We found this trial at
15
sites
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