Status:
TERMINATED
Study of Safety of Foradil in Patients With Persistent Asthma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Persistent Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
The purpose of this study was to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in adolescents and ad...
Detailed Description
This was a 26 week, double blind, randomized, active-controlled safety study of Foradil in free combination with inhaled corticosteroid versus an inhaled corticosteroid alone in adults and adolescent ...
Eligibility Criteria
Inclusion
- Key
- Written informed consent, and assent if applicable, must be obtained before any assessment is performed.
- Male or female patients 12 years of age and older
- Confirmed diagnosis of persistent asthma, as defined by national and international asthma guidelines (e.g., GINA; NIH; etc.) for at least 1 year prior to study enrollment.
- PEF≥50% of predicted normal value.
- Current and appropriate use of one of the treatments listed in the protocol for asthma.
- Recent asthma exacerbation between 30 days and 12 months prior to randomization that either:
- required treatment with systemic corticosteroids (tablets, suspension, or injection) or
- required hospitalization (defined as an inpatient stay or \>24-hour stay in an observation area in an emergency room or other equivalent facility)
- Key
Exclusion
- History of life-threatening asthma episode that required intubation and/or was associated with hypercapnia requiring non-invasive ventilatory support.
- Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other respiratory abnormalities other than asthma.
- Current evidence of, or past physician assessment of, chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.
- History of smoking ≥ 10 pack years.
- Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine.
- Suspected or documented bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved at randomization.
- Worsening/Unstable asthma within 7 days prior to randomization.
- Any asthma exacerbation requiring systemic corticosteroids within 30 days of randomization or more than 4 separate exacerbations in the 12 months preceding randomization.
- Two or more hospitalizations for greater than 24 hours duration for treatment of asthma in the 12 months preceding randomization.
- History of hypersensitivity to any beta2-agonist, sympathomimetic drug, inhaled corticosteroids, or systemic corticosteroid therapy or any component of the possible study treatments in this trial, including severe milk protein hypersensitivity.
- Use of anti-IgE (e.g., omalizumab) or any other monoclonal antibody, in the 6 months prior to randomization.
- Use of (Beta) β-blockers within 1 day prior to first dose of study medication.
- Use of ICS, LABA, ICS+LABA, LTRAs, leukotriene modifiers, anticholinergics, or theophylline must be discontinued prior to the first dose of investigational treatment.
- Use of a potent CYP3A4 inhibitor within 4 weeks of randomization (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin).
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
827 Patients enrolled
Trial Details
Trial ID
NCT01845025
Start Date
May 1 2013
End Date
May 1 2016
Last Update
March 21 2017
Active Locations (27)
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1
Novartis Investigative Site
Avondale, Arizona, United States, 85323
2
Novartis Investigative Site
North Hollywood, California, United States, 91606
3
Novartis Investigative Site
Bradenton, Florida, United States, 34209
4
Novartis Investigative Site
Miami, Florida, United States, 33126