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Trial record 4 of 12 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol) | ( Map: France )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01803555
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : August 4, 2014
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: Budesonide/Formoterol SPIROMAX® Drug: SYMBICORT® TURBOHALER® Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 605 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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®
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.

Primary Outcome Measures :
  1. Change from baseline in weekly average of daily trough (predose and pre-rescue bronchodilator) AM Peak expiratory flow (PEF) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in weekly average of daily PM PEF [ Time Frame: 12 weeks ]
  2. Safety Parameters [ Time Frame: From signing of the informed consent form through the 12 week treatment period ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01803555

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Sponsors and Collaborators
Teva Pharmaceutical Industries

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Teva Pharmaceutical Industries Identifier: NCT01803555     History of Changes
Other Study ID Numbers: BFS-AS-306
2013-000081-11 ( EudraCT Number )
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: August 4, 2014
Last Verified: August 2014
Keywords provided by Teva Pharmaceutical Industries:
Budesonide/Formoterol SPIROMAX®
Additional relevant MeSH terms:
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Formoterol Fumarate
Budesonide, Formoterol Fumarate Drug Combination
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action