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 (ELIOT)

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX; Drug: SYMBICORT TURBOHALER budesonide and formoterol fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02062463

BFS-AS-40035

2013-004630-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 485 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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485 participants in 4 patient groups

Stage 1: Empty Spiromax Followed by Empty Turbohaler

No Intervention group

Description:

Participants will be trained on the proper use of empty Spiromax followed by empty Turbohaler devices.

Stage 1: Empty Turbohaler Followed by Empty Spiromax

No Intervention group

Description:

Participants will be trained on the proper use of empty Turbohaler followed by empty Spiromax devices.

Stage 2: BF Spiromax

Experimental group

Description:

Participants who have currently received 800 to 1000 micrograms (μg) beclomethasone-equivalent inhaled corticosteroid (ICS) per day will receive budesonide/formoterol twice daily using the BF Spiromax 160/4.5 device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax will be 640 μg and 18 μg, respectively. Participants who have currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day will receive budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax will be 1280 μg and 36 μg, respectively.

Treatment:

Drug: Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX

Stage 2: Symbicort Turbohaler

Active Comparator group

Description:

Participants who have currently received 800 to 1000 μg beclomethasone-equivalent ICS per day will receive budesonide/formoterol twice daily using the Symbicort Turbohaler 200/6 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler will be 800 μg and 24 μg respectively. Participants who have currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day will receive budesonide/formoterol twice daily using the Symbicort Turbohaler 400/12 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler will be 1600 μg and 48 μg respectively.

Treatment:

Drug: SYMBICORT TURBOHALER budesonide and formoterol fumarate