Clinical trial NCT02062463: Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® as Compared to SYMBICORT® TURBOHALER® as Treatment for Adult Participants With Asthma
Official title: A 12-Week, Randomized, Open-Label, Parallel-Group Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® (160/4.5 and 320/9 mcg) as Compared With SYMBICORT® TURBOHALER® (200/6 and 400/12 mcg) as Treatment for Adult Patients With Asthma (The Easy Low Instruction Over Time [ELIOT] Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-13
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is conducted to assess whether training participants on proper use of BF SPIROMAX and Symbicort TURBOHALER will improve their device-handling technique and potentially improve their treatment outcome, that is, better asthma control.


Eligibility criteria: Inclusion Criteria:

* The participant has a diagnosis of asthma in accordance with Global Initiative for Asthma (GINA) criteria as evidenced by a United Kingdom (UK) quality outcome framework approved Read code (UK diagnostic coding system).
* The participant is receiving step 3 or 4 therapy for asthma as defined by the British Thoracic Society (BTS) guidelines (daily doses of beclomethasone dipropionate \[BDP\]-equivalent ICS) ≥800 mcg to 2000 μg as part of fixed- or free combinations with long-acting β2-agonists (LABA).
* If participant is a female of childbearing potential (post-menarche or less than 2 years post-menopausal or not surgically sterile), the participant must be willing to commit to using a medically accepted method of contraception for the duration of study and 30 days after discontinuing study drug.
* The participant, as judged by the investigator, must be willing and able to understand risks and benefits of study participation to give informed consent and to comply with all study requirements as specified in this protocol for the entire duration of their study participation.
* The participant is SPIROMAX and TURBOHALER naïve (no use of a SYMBICORT TURBOHALER device in the last 6 months, minimizing carryover from prior device use).
* If female and of childbearing potential, the participant must have a negative urine pregnancy test.

  * other criteria apply, please contact the investigator for additional information.

Exclusion Criteria:

* The participant has any clinically significant uncontrolled medical condition (treated or untreated) that, in the judgment of the investigator, will cause participation in the study to be detrimental to the participant.
* The participant has participated in a Teva-sponsored clinical study with BF SPIROMAX in the last 6 months.
* The participant is a pregnant, attempting to become pregnant, or breast feeding. (Any woman becoming pregnant during the study will be withdrawn from the study.)
* The participant has used a clinical trial investigational drug within 1 month before the screening visit.
* The participant has an ongoing asthma exacerbation or has received OCS and/or antibiotics for a lower respiratory condition (proxy measure for identifying an asthma exacerbation and/or lower respiratory infection, suggestive of altered inspiratory capabilities) in the 2 weeks preceding visit 1.
* The participant is currently receiving any OCS (including long or short courses).
* The participant has a significant chronic lower respiratory tract disease other than asthma (for example chronic obstructive pulmonary disease \[COPD\], cystic fibrosis or interstitial lung disease). Conditions that are not predominant, such as minor degrees of bronchiectasis, are not a reason for exclusion.
* The participant has a known allergy or severe sensitivity to the constituents of the study drugs (SPIROMAX or TURBOHALER),for example, to lactose or to milk protein.

  * other criteria apply, please contact the investigator for additional information.

Primary outcomes:
measure: Stage 1: Percentage of Participants Achieving Device Mastery
timeFrame: Baseline (Day 1)
measure: Stage 2: Percentage of Participants Maintaining Device Mastery
timeFrame: Baseline up to Week 12
Secondary outcomes:
measure: Stage 1: Percentage of Participants Achieving Device Mastery by Step 1
timeFrame: Day 1
measure: Stage 1: Percentage of Participants Achieving Device Mastery by Step 2
timeFrame: Day 1
measure: Stage 1: Number of Steps Taken to Achieve Device Mastery
timeFrame: Baseline (Day 1)
measure: Stage 1: Number of Nurse-Observed Errors
timeFrame: Day 1
measure: Stage 1: Patient Satisfaction and Preference Questionnaire (PASAPQ) Total Score
timeFrame: Baseline (Day 1)
measure: Composite Endpoint: Stage 2: Total Number of Observed Errors (Nurse and Technology [Vitalograph Pneumotrac Spirometer])
timeFrame: Baseline up to Week 12
measure: Stage 2: Number of Technology-Observed Errors (Vitalograph Pneumotrac Spirometer)
timeFrame: Week 12
measure: Stage 2: Total Number of Handling Errors
timeFrame: Baseline up to Week 12
measure: Stage 2: Change in Handling Errors From Stage 1 to Stage 2
timeFrame: Baseline (Day 1), Week 12
measure: Stage 2: Number of Participants In Pre-specified Treatment Adherence Categories (Assessed by Device Dose Counters)
timeFrame: Baseline up to Week 12
measure: Stage 2: Change From Baseline in 6-Item Asthma Control Questionnaire (ACQ) (Excluding Forced Expiratory Volume in 1 Second [FEV1] Question) Score at Weeks 4, 8, and 12
timeFrame: Baseline, Weeks 4, 8, and 12
measure: Stage 2: Change From Baseline in 7-Item ACQ
timeFrame: Baseline, Week 12
measure: Stage 2: Time to First Treatment Failure
timeFrame: Baseline up to Week 12
measure: Stage 2: Number of Participants With Severe Asthma Exacerbations
timeFrame: Week 12
measure: Stage 2: Impact of Maintaining Device Mastery on Time to Treatment Failure
timeFrame: Baseline Up to Week 12
measure: Stage 2: Impact of Maintaining Device Mastery on Asthma Control Questionnaire Score
timeFrame: Baseline Up to Week 12
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Week 12
Other outcomes:
Locations:
city: Axbridge
country: United Kingdom
facility: Teva Investigational Site 34092
city: Babbacombe
country: United Kingdom
facility: Teva Investigational Site 34081
city: Beccles
country: United Kingdom
facility: Teva Investigational Site 34103
city: Bishops Stortford
country: United Kingdom
facility: Teva Investigational Site 34144
city: Burnhope
country: United Kingdom
facility: Teva Investigational Site 34066
city: Bury St Edmunds
country: United Kingdom
facility: Teva Investigational Site 34064
city: Bury St Edmunds
country: United Kingdom
facility: Teva Investigational Site 34107
city: Cheltenham
country: United Kingdom
facility: Teva Investigational Site 34072
city: Chippenham
country: United Kingdom
facility: Teva Investigational Site 34063
city: Chipping Norton
country: United Kingdom
facility: Teva Investigational Site 34122
city: Clacton-on-Sea
country: United Kingdom
facility: Teva Investigational Site 34134
city: Colchester
country: United Kingdom
facility: Teva Investigational Site 34136
city: Colchester
country: United Kingdom
facility: Teva Investigational Site 34143
city: Colchester
country: United Kingdom
facility: Teva Investigational Site 34111
city: Colchester
country: United Kingdom
facility: Teva Investigational Site 34126
city: Colchester
country: United Kingdom
facility: Teva Investigational Site 34135
city: Colchester
country: United Kingdom
facility: Teva Investigational Site 34120
city: Daventry
country: United Kingdom
facility: Teva Investigational Site 34075
city: Daventry
country: United Kingdom
facility: Teva Investigational Site 34112
city: East Hunsbury
country: United Kingdom
facility: Teva Investigational Site 34083
city: East Tillbury
country: United Kingdom
facility: Teva Investigational Site 34145
city: Exmouth
country: United Kingdom
facility: Teva Investigational Site 34099
city: Exmouth
country: United Kingdom
facility: Teva Investigational Site 34110
city: Goldhay
country: United Kingdom
facility: Teva Investigational Site 34102
city: Great Yarmouth
country: United Kingdom
facility: Teva Investigational Site 34119
city: Harrogate
country: United Kingdom
facility: Teva Investigational Site 34079
city: Harrogate
country: United Kingdom
facility: Teva Investigational Site 34068
city: Hemel Henpstead
country: United Kingdom
facility: Teva Investigational Site 34139
city: Hinckley
country: United Kingdom
facility: Teva Investigational Site 34142
city: Huntingdon
country: United Kingdom
facility: Teva Investigational Site 34116
city: Ipswich
country: United Kingdom
facility: Teva Investigational Site 34113
city: Lancashire
country: United Kingdom
facility: Teva Investigational Site 34098
city: Leicester
country: United Kingdom
facility: Teva Investigational Site 34128
city: Leicester
country: United Kingdom
facility: Teva Investigational Site 34127
city: Leigh-on-Sea
country: United Kingdom
facility: Teva Investigational Site 34141
city: Liskeard
country: United Kingdom
facility: Teva Investigational Site 34082
city: Lister House
country: United Kingdom
facility: Teva Investigational Site 34146
city: Liverpool
country: United Kingdom
facility: Teva Investigational Site 34147
city: Loughborough
country: United Kingdom
facility: Teva Investigational Site 34080
city: Lowestoft
country: United Kingdom
facility: Teva Investigational Site 34086
city: Luton
country: United Kingdom
facility: Teva Investigational Site 34138
city: Manchester
country: United Kingdom
facility: Teva Investigational Site 34076
city: Newton Aycliffe
country: United Kingdom
facility: Teva Investigational Site 34109
city: Norwich'
country: United Kingdom
facility: Teva Investigational Site 34106
city: Norwich
country: United Kingdom
facility: Teva Investigational Site 34095
city: Norwich
country: United Kingdom
facility: Teva Investigational Site 34108
city: Norwich
country: United Kingdom
facility: Teva Investigational Site 34091
city: Norwich
country: United Kingdom
facility: Teva Investigational Site 34123
city: Oadby
country: United Kingdom
facility: Teva Investigational Site 34085
city: Oldham
country: United Kingdom
facility: Teva Investigational Site 34070
city: Orby
country: United Kingdom
facility: Teva Investigational Site 34114
city: Oxon
country: United Kingdom
facility: Teva Investigational Site 34118
city: Pickering
country: United Kingdom
facility: Teva Investigational Site 34137
city: Reading
country: United Kingdom
facility: Teva Investigational Site 34124
city: Redditch
country: United Kingdom
facility: Teva Investigational Site 34089
city: Sheringham
country: United Kingdom
facility: Teva Investigational Site 34100
city: Stalham
country: United Kingdom
facility: Teva Investigational Site 34117
city: Stanley
country: United Kingdom
facility: Teva Investigational Site 34105
city: Stowmarket
country: United Kingdom
facility: Teva Investigational Site 34065
city: Strensall
country: United Kingdom
facility: Teva Investigational Site 34067
city: Swindon
country: United Kingdom
facility: Teva Investigational Site 34078
city: Thaxted
country: United Kingdom
facility: Teva Investigational Site 34140
city: Thornton-Cleveleys
country: United Kingdom
facility: Teva Investigational Site 34096
city: Trowbridge
country: United Kingdom
facility: Teva Investigational Site 34088
city: Trowbridge
country: United Kingdom
facility: Teva Investigational Site 34077
city: Waterlooville
country: United Kingdom
facility: Teva Investigational Site 34071
city: Waterlooville
country: United Kingdom
facility: Teva Investigational Site 34073
city: Wells-Next-Sea
country: United Kingdom
facility: Teva Investigational Site 34084
city: Wisbech
country: United Kingdom
facility: Teva Investigational Site 34115
city: Woodbridge
country: United Kingdom
facility: Teva Investigational Site 34069
city: Woodbridge
country: United Kingdom
facility: Teva Investigational Site 34074
city: Worcester
country: United Kingdom
facility: Teva Investigational Site 34090
city: Wymondham
country: United Kingdom
facility: Teva Investigational Site 34121
city: York
country: United Kingdom
facility: Teva Investigational Site 34101
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: