Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® as Compared to SYMBICORT® TURBOHALER® as Treatment for Adult Patients With Asthma

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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, ie, better asthma control.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Treatments: Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate

Criteria

Inclusion Criteria:

• Written informed consent signed and dated by the adult patient before conducting any study related procedures.

• The patient is a man or woman 18 through 75 years of age as of the screening visit.

• The patient 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 patient is receiving step 3 or 4 therapy for asthma as defined by the British Thoracic Society (BTS) guidelines (daily doses of BDP-equivalent inhaled corticosteroid (ICS) ≥800 mcg to 2000 mcg as part of fixed or free combinations with long-acting beta-agonists (LABA).

• If patient is a female of childbearing potential (postmenarche or less than 2 years post-menopausal or not surgically sterile) the patient 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 patient, 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 patient is SPIROMAX and TURBOHALER naïve (no use of a TURBOHALER device in the last 6 months, minimizing carryover from prior device use).

• If female, the patient must have a negative urine pregnancy test. o other criteria apply, please contact the investigator for additional information

Exclusion Criteria:

• The patient 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 patient.

• The patient has participated in a Teva sponsored clinical study with BF SPIROMAX in the last 6 months.

• The patient is a pregnant, attempting to become pregnant, or breast feeding. (Any woman becoming pregnant during the study will be withdrawn from the study.)

• The patient has used a clinical trial investigational drug within 1 month before the screening visit.

• The patient 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

• The patient is currently receiving any OCS (including long or short courses).

• The patient has a significant chronic lower respiratory tract disease other than asthma eg 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 patient has a known allergy or severe sensitivity to the constituents of the study drugs (SPIROMAX or TURBOHALER) eg, to lactose or to milk protein.

• other criteria apply, please contact the investigator for additional information