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

Asthma Clinical Trial

— ELIOT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062463
• Other study ID #: BFS-AS-40035
• Secondary ID: 2013-004630-14
• Status: Completed
• Phase: Phase 3
• Start date: May 28, 2014
• Est. completion date: March 13, 2015

Study information

• Verified date: September 2023
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 485
• Est. completion date: March 13, 2015
• Est. primary completion date: March 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ß2-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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX
SPIROMAX (BF) Budesonide and formoterol fumarate dehydrate (160/4.5 and 320/9 µg)
• SYMBICORT TURBOHALER budesonide and formoterol fumarate
SYMBICORT® TURBOHALER® (200/6 and 400/12 µg)

Locations

Country	Name	City	State
United Kingdom	Teva Investigational Site 34092	Axbridge
United Kingdom	Teva Investigational Site 34081	Babbacombe
United Kingdom	Teva Investigational Site 34103	Beccles
United Kingdom	Teva Investigational Site 34144	Bishops Stortford
United Kingdom	Teva Investigational Site 34066	Burnhope
United Kingdom	Teva Investigational Site 34064	Bury St Edmunds
United Kingdom	Teva Investigational Site 34107	Bury St Edmunds
United Kingdom	Teva Investigational Site 34072	Cheltenham
United Kingdom	Teva Investigational Site 34063	Chippenham
United Kingdom	Teva Investigational Site 34122	Chipping Norton
United Kingdom	Teva Investigational Site 34134	Clacton-on-Sea
United Kingdom	Teva Investigational Site 34111	Colchester
United Kingdom	Teva Investigational Site 34120	Colchester
United Kingdom	Teva Investigational Site 34126	Colchester
United Kingdom	Teva Investigational Site 34135	Colchester
United Kingdom	Teva Investigational Site 34136	Colchester
United Kingdom	Teva Investigational Site 34143	Colchester
United Kingdom	Teva Investigational Site 34075	Daventry
United Kingdom	Teva Investigational Site 34112	Daventry
United Kingdom	Teva Investigational Site 34083	East Hunsbury
United Kingdom	Teva Investigational Site 34145	East Tillbury
United Kingdom	Teva Investigational Site 34099	Exmouth
United Kingdom	Teva Investigational Site 34110	Exmouth
United Kingdom	Teva Investigational Site 34102	Goldhay
United Kingdom	Teva Investigational Site 34119	Great Yarmouth
United Kingdom	Teva Investigational Site 34068	Harrogate
United Kingdom	Teva Investigational Site 34079	Harrogate
United Kingdom	Teva Investigational Site 34139	Hemel Henpstead
United Kingdom	Teva Investigational Site 34142	Hinckley
United Kingdom	Teva Investigational Site 34116	Huntingdon
United Kingdom	Teva Investigational Site 34113	Ipswich
United Kingdom	Teva Investigational Site 34098	Lancashire
United Kingdom	Teva Investigational Site 34127	Leicester
United Kingdom	Teva Investigational Site 34128	Leicester
United Kingdom	Teva Investigational Site 34141	Leigh-on-Sea
United Kingdom	Teva Investigational Site 34082	Liskeard
United Kingdom	Teva Investigational Site 34146	Lister House
United Kingdom	Teva Investigational Site 34147	Liverpool
United Kingdom	Teva Investigational Site 34080	Loughborough
United Kingdom	Teva Investigational Site 34086	Lowestoft
United Kingdom	Teva Investigational Site 34138	Luton
United Kingdom	Teva Investigational Site 34076	Manchester
United Kingdom	Teva Investigational Site 34109	Newton Aycliffe
United Kingdom	Teva Investigational Site 34091	Norwich
United Kingdom	Teva Investigational Site 34095	Norwich
United Kingdom	Teva Investigational Site 34108	Norwich
United Kingdom	Teva Investigational Site 34123	Norwich
United Kingdom	Teva Investigational Site 34106	Norwich'
United Kingdom	Teva Investigational Site 34085	Oadby
United Kingdom	Teva Investigational Site 34070	Oldham
United Kingdom	Teva Investigational Site 34114	Orby
United Kingdom	Teva Investigational Site 34118	Oxon
United Kingdom	Teva Investigational Site 34137	Pickering
United Kingdom	Teva Investigational Site 34124	Reading
United Kingdom	Teva Investigational Site 34089	Redditch
United Kingdom	Teva Investigational Site 34100	Sheringham
United Kingdom	Teva Investigational Site 34117	Stalham
United Kingdom	Teva Investigational Site 34105	Stanley
United Kingdom	Teva Investigational Site 34065	Stowmarket
United Kingdom	Teva Investigational Site 34067	Strensall
United Kingdom	Teva Investigational Site 34078	Swindon
United Kingdom	Teva Investigational Site 34140	Thaxted
United Kingdom	Teva Investigational Site 34096	Thornton-Cleveleys
United Kingdom	Teva Investigational Site 34077	Trowbridge
United Kingdom	Teva Investigational Site 34088	Trowbridge
United Kingdom	Teva Investigational Site 34071	Waterlooville
United Kingdom	Teva Investigational Site 34073	Waterlooville
United Kingdom	Teva Investigational Site 34084	Wells-Next-Sea
United Kingdom	Teva Investigational Site 34115	Wisbech
United Kingdom	Teva Investigational Site 34069	Woodbridge
United Kingdom	Teva Investigational Site 34074	Woodbridge
United Kingdom	Teva Investigational Site 34090	Worcester
United Kingdom	Teva Investigational Site 34121	Wymondham
United Kingdom	Teva Investigational Site 34101	York

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stage 1: Percentage of Participants Achieving Device Mastery	Device mastery was defined as absence of healthcare professional (HCP)-observed errors by the end of Step 3 of a 6-step standardized device training protocol for empty Spiromax compared to empty Turbohaler. The 6 steps of device training protocol were: Step 1 - Intuitive use; Step 2 - Patient information leaflet; Step 3 - Instructional video; Step 4 - HCP tuition; Step 5 - HCP tuition (1st repeat); Step 6 - HCP tuition (2nd repeat).	Baseline (Day 1)
Primary	Stage 2: Percentage of Participants Maintaining Device Mastery	Maintenance of device mastery was defined as absence of HCP-observed errors after 12 weeks of device use.	Baseline up to Week 12
Secondary	Stage 1: Percentage of Participants Achieving Device Mastery by Step 1	The number of participants achieving device mastery by Step 1 (no training/intuitive use) of the device training process. Device mastery was defined as the absence of nurse-observed errors by the end of Step 3 of a 6-step standardized device training protocol for each device. The 6 training steps were as follows: Step 1, intuitive use; Step 2, patient device information leaflet; Step 3, instructional video; Step 4, nurse tuition; Step 5, nurse tuition (1st repeat); Step 6, nurse tuition (2nd repeat). After each training step an assessment of device use was carried out by the nurse using a pre-defined list of inhaler errors.	Day 1
Secondary	Stage 1: Percentage of Participants Achieving Device Mastery by Step 2	The number of participants achieving device mastery by Step 2 (patient device information leaflet) of the device training process. Device mastery was defined as the absence of nurse-observed errors by the end of Step 3 of a 6-step standardized device training protocol for each device. The 6 training steps were as follows: Step 1, intuitive use; Step 2, patient device information leaflet; Step 3, instructional video; Step 4, nurse tuition; Step 5, nurse tuition (1st repeat); Step 6, nurse tuition (2nd repeat). After each training step an assessment of device use was carried out by the nurse using a pre-defined list of inhaler errors.	Day 1
Secondary	Stage 1: Number of Steps Taken to Achieve Device Mastery		Baseline (Day 1)
Secondary	Stage 1: Number of Nurse-Observed Errors		Day 1
Secondary	Stage 1: Patient Satisfaction and Preference Questionnaire (PASAPQ) Total Score	The PASAPQ is a multi-item measure of inhalation device satisfaction and preference designed specifically for participants with asthma and chronic obstructive pulmonary disease. The PASAPQ includes a total of 14 device satisfaction items, including an overall satisfaction item. The total score was the sum of the 13 items related to performance and convenience domains (7 items for performance domain: Questions 1-5, 10-11, and 6 items for convenience domain: Questions 6-9, 12-13). Each PASAPQ item had response options ranging from 1 (very dissatisfied) to 7 (very satisfied). To calculate the total score, the items within each domain were first summed and then transformed to a 0 (least) or 100 (most) point scale, with higher scores indicating greater satisfaction.	Baseline (Day 1)
Secondary	Composite Endpoint: Stage 2: Total Number of Observed Errors (Nurse and Technology [Vitalograph Pneumotrac Spirometer])	Composite score calculated as the sum of nurse observed errors and technology-observed errors.	Baseline up to Week 12
Secondary	Stage 2: Number of Technology-Observed Errors (Vitalograph Pneumotrac Spirometer)		Week 12
Secondary	Stage 2: Total Number of Handling Errors	Total number of device handling errors included HCP observed errors and technology observed errors.	Baseline up to Week 12
Secondary	Stage 2: Change in Handling Errors From Stage 1 to Stage 2	The difference in the number of handling errors identified after participant training using the patient device information leaflet at stage 1 and after 12 weeks of treatment (end of stage 2).	Baseline (Day 1), Week 12
Secondary	Stage 2: Number of Participants In Pre-specified Treatment Adherence Categories (Assessed by Device Dose Counters)	Treatment adherence was categorized (as less than or equal to 50%, 51%-70%, 71%-99%, and 100%) and compared across treatment groups using a chi-square test.	Baseline up to Week 12
Secondary	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	The ACQ is a 7-item, validated tool for assessing asthma control (Juniper et al 1999). Thinking about their asthma for the last 7 days, participants were asked to evaluate their asthma against 5 symptom items and a rescue bronchodilator use question using a 7-point scale (0=no impairment and 6=maximum impairment). Spirometry data were used to grade the percent predicted forced expiratory volume in 1 second (FEV1) on a 7-point scale (0 to 6). The score is the mean of the first 6 questions (excluding the FEV1 question), generating a value from 0 (totally controlled) to 6 (severely uncontrolled). A negative change from Baseline indicates improvement.	Baseline, Weeks 4, 8, and 12
Secondary	Stage 2: Change From Baseline in 7-Item ACQ	The ACQ is a 7-item, validated tool for assessing asthma control (Juniper et al 1999). Thinking about their asthma for the last 7 days, participants were asked to evaluate their asthma against 5 symptom items and a rescue bronchodilator use question using a 7-point scale (0=no impairment and 6=maximum impairment). Spirometry data were used to grade the percent predicted FEV1 on a 7-point scale (0 to 6). The ACQ score is the mean of the 7 questions, generating a value from 0 (totally controlled) to 6 (severely uncontrolled). A negative change from Baseline indicates improvement.	Baseline, Week 12
Secondary	Stage 2: Time to First Treatment Failure	Time to treatment failure was defined as change of asthma treatment or treatment for an asthma exacerbation or lower respiratory tract infection.	Baseline up to Week 12
Secondary	Stage 2: Number of Participants With Severe Asthma Exacerbations	Severe asthma exacerbation was defined as a hospitalization or emergency room attendance for asthma, or an acute course of oral corticosteroids (OCS).	Week 12
Secondary	Stage 2: Impact of Maintaining Device Mastery on Time to Treatment Failure	The impact of maintaining device mastery on time to treatment failure (defined as change of asthma treatment or treatment for an asthma exacerbation or lower respiratory tract infection) was assessed by comparing the time to treatment failure for participants with and without device mastery. Device mastery was defined as the absence of nurse-observed errors by the end of Step 3 of a 6-step standardized device training protocol for each device.	Baseline Up to Week 12
Secondary	Stage 2: Impact of Maintaining Device Mastery on Asthma Control Questionnaire Score	The impact of maintaining device mastery on asthma control was assessed by comparing the 7-item ACQ scores for participants with and without device mastery. The ACQ is a 7-item, validated tool for assessing asthma control (Juniper et al 1999). Thinking about their asthma for the last 7 days, participants were asked to evaluate their asthma against 5 symptom items and a rescue bronchodilator use question using a 7-point scale (0=no impairment and 6=maximum impairment). Spirometry data were used to grade the percent predicted FEV1 on a 7-point scale (0 to 6). The ACQ score is the mean of the 7 questions, generating a value from 0 (totally controlled) to 6 (severely uncontrolled). Device mastery was defined as the absence of nurse-observed errors by the end of Step 3 of a 6-step standardized device training protocol for each device.	Baseline Up to Week 12
Secondary	Number of Participants With Adverse Events (AEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.	Baseline up to Week 12