To understand how easily patients learn to use and maintain correct use of BF Spiromax compared to Symbicort Turbohaler.

Conditions: Persistent asthma
MedDRA version: 17.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2013-004630-14-GB

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

a. Written informed consent/assent is obtained: For adult patients, written informed consent signed and dated by the patient before conducting any study related procedures.
b. The patient is a man or woman 18 through 75 years of age as of the screening visit.
c. The patient has a diagnosis of asthma in accordance with Global Initiative for Asthma (GINA) criteria as evidenced by a UK quality outcome framework approved Read code (UK diagnostic coding
system).
d. The patient is receiving step 3 or 4 therapy for asthma as defined by the BTS guidelines (daily doses of BDP-equivalent ICS =800 mcg to 2000 mcg as part of fixed or free combinations with LABA).
e. The patient does not have an ongoing asthma exacerbation.
f. Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the
duration of the study and for 30 days after discontinuation of study drug. Acceptable methods of contraception include intrauterine device (IUD) known to have a failure rate of less than 1% per year,
steroidal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, abstinence, and partner vasectomy.
g. The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow up
evaluation as specified in this protocol.
h. The patient is SPIROMAX and TURBOHALER naïve (no use of a TURBOHALER device in the last 6 months, minimizing carryover from prior device use).
The following criteria apply to stage 2 of this study:
i. Patient has uncontrolled or partly controlled asthma (using GINA criteria).
j. Patient has demonstrated at least 1 error in current device inhaler technique.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

a. The patient has any clinically significant uncontrolled medical condition (treated or untreated).
b. The patient has participated in a Teva sponsored clinical study with BF SPIROMAX in the last 6 months.
c. The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
d. The patient has used an investigational drug within 1 month before the screening visit.
e. The patient has received OCS and/or antibiotics for a lower respiratory condition in the 2 weeks preceding visit 1A (proxy measure for identifying an asthma exacerbation and/or lower respiratory
infection, suggestive of altered inspiratory capabilities).
f. The patient is currently receiving any OCS (including long or short courses).
g. 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 following criteria apply to stage 2 of this study:
h. The patient is unable to achieve mastery of both BF SPIROMAX and SYMBICORT TURBOHALER.
i. The patient has controlled asthma (using GINA criteria).
j. The patient demonstrates an absence of errors in current device inhaler technique.