Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER®

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01803555
First received: February 28, 2013
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

The primary objective of the study is to establish whether budesonide/formoterol fumarate dihydrate (BF) SPIROMAX 160/4.5 mcg is as effective as SYMBICORT TURBOHALER 200/6 mcg administered twice daily in patients with persistent asthma.


Condition Intervention Phase
Asthma
Drug: Budesonide/Formoterol SPIROMAX®
Drug: SYMBICORT® TURBOHALER®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-Week Efficacy and Safety Evaluation of Budesonidel/Formoterol SPIROMAX® 160/4.5 mcg Inhalation Powder Versus SYMBICORT® TURBOHALER® 200/6 mcg in Adult and Adolescent Patients With Persistent Asthma

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Change from baseline in weekly average of daily trough (predose and pre-rescue bronchodilator) AM Peak expiratory flow (PEF) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in weekly average of daily PM PEF [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety Parameters [ Time Frame: From signing of the informed consent form through the 12 week treatment period ] [ Designated as safety issue: Yes ]
    The safety of BF SPIROMAX will be assessed throughout the study by evaluating adverse events, oropharynx examination results, physical examination results, and vital signs measurements.


Estimated Enrollment: 600
Study Start Date: June 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Budesonide/Formoterol SPIROMAX®
2 inhalations of BF Spiromax at a dosage of 160/4.5 mcg and 2 inhalations of SYMBICORT placebo administered twice daily (AM and PM) during the 12-week treatment period.
Drug: Budesonide/Formoterol SPIROMAX®
Active Comparator: SYMBICORT® TURBOHALER®
2 inhalations of SYMBICORT TURBOHALER at a dosage of 200/6 mcg and 2 inhalations of placebo SPIROMAX administered twice daily (AM and PM) during the 12-week treatment period.
Drug: SYMBICORT® TURBOHALER®

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.
  • 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.
  • Asthma Diagnosis: The asthma diagnosis must be in accordance with the Global Initiative for Asthma (GINA).
  • Other criteria apply.

Exclusion Criteria:

  • 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.
  • 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.
  • 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.
  • Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma.
  • 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.
  • Other criteria apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803555

  Show 92 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01803555     History of Changes
Other Study ID Numbers: BFS-AS-306, 2013-000081-11
Study First Received: February 28, 2013
Last Updated: May 20, 2014
Health Authority: Austria: Austrian Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Ministry of Health
Germany: Ministry of Health
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Spain: Ministry of Health
Sweden: Medical Products Agency
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Teva Pharmaceutical Industries:
Budesonide/Formoterol SPIROMAX®
SYMBICORT® TURBOHALER®
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014