A 12-Week Efficacy and Safety Evaluation of Budesonide/FormoterolSPIROMAX® 160/4.5 mcg Inhalation Powder Versus SYMBICORT®TURBOHALER® 200/6 mcg in Adult and Adolescent Patients withPersistent Asthma.

Teva Branded Pharmaceutical Products R&D, Inc.0 sites600 target enrollmentApril 16, 2013

DrugsSymbicort® Turbohaler® 200 /6 inhalation powder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Enrollment: 600
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 16, 2013

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Eligibility Criteria

Inclusion Criteria

•a. Informed consent/assent: For adult patients, written informed consent signed and dated by the patient before conducting any study related procedures; for minor patients, written informed consent signed and dated by the parent/legal guardian and written assent signed and dated by the patient before conducting any study related procedure.
•b. Male or female patients 12 years and older as of the screening visit. Male or female patients 18 years and older, as of the screening visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adult patients only.
•c. General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study.
•d. Asthma Diagnosis: The asthma diagnosis must be in accordance with the Global Initiative for Asthma (GINA).
•e. Patient has an ACQ score of \=1\.0 at the screening visit.
•f. Severity of Disease: Persistent asthma, with an FEV1 40\-85% predicted for age, height, gender and race, as per the third National Health and Nutrition Examination Survey (NHANES III) reference values, with adjustments to predicted values for African American patients, for a minimum of 3 months duration, and that has been stable for at least 30 days before the screening visit, as defined by clinical history.
•g. Reversibility of Disease: Demonstrated a \=12% reversibility of FEV1 within 30 minutes after 2\-4 inhalations of albuterol/salbutamol (if required, spacers are permitted for reversibility testing) at the screening visit. Documented historical reversibility of \=12% to a beta\-agonist in the 12 months before the screening visit is also acceptable.
•h. Current Asthma Therapy: Patients will be required to be on a short\-acting ß2 agonist (SABA) and inhaled corticosteroid (ICS) for a minimum of 8 weeks before the screening visit and have been maintained on a stable dose of inhaled corticosteroids for 4 weeks before the screening visit at on of the doses specified in the protocol.
•i. Short\-Acting ß2\-Agonists: All patients must be able to replace their current SABA with albuterol/salbutamol at the screening visit for use as needed for the duration of the study. Nebulized albuterol/salbutamol will not be allowed at any time during the study. Patients must be able to withhold all inhaled short\-acting ß2\-sympathomimetic bronchodilators for at least 6 hours before all study visits.
•j. If female, is currently not pregnant, breast feeding, or attempting to become pregnant, and is of Nonchildbearing potential, defined as:

Exclusion Criteria

•a. History of life\-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
•b. Culture\-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks before the screening visit. In addition, the patient must be excluded if such infection occurs between the screening visit and the baseline visit.
•c. Any asthma exacerbation requiring oral corticosteroids within one month of the screening visit. A patient must not have been hospitalized for asthma within 6 months before the screening visit.
•d. Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma.
•e. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular conditions (eg, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine conditions (eg, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison’s disease, Cushing’s syndrome), gastrointestinal conditions (eg, poorly\-controlled peptic ulcer, gastroesophageal reflux disease \[GERD]), or pulmonary conditions (eg, chronic bronchitis, emphysema, bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the patient at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition became exacerbated during the study.
•f. Have any of the following conditions that, in the judgment of the investigator, might cause participation in this study to be detrimental to the patient, including, but not limited to:
•\- Current malignancy, excluding basal cell carcinoma. History of malignancy is acceptable only if the patient has been in remission for one year prior to the screening visit. (Remission is defined as no current evidence of malignancy and no treatment for the malignancy in the 12 months before the screening visit)
•\- Current or untreated tuberculosis. History of tuberculosis is acceptable only if a patient has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years
•\- Uncontrolled hypertension (systolic blood pressure (BP) \=160 or diastolic BP \>100\)
•\- Stroke within 3 months before the screening visit