Study of Safety of Foradil in Patients With Persistent Asthma
NCT ID: NCT01845025
Last Updated: 2017-03-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
827 participants
INTERVENTIONAL
2013-05-31
2016-05-31
Brief Summary
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Detailed Description
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The efficacy assessment is the secondary objective.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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FOM 12 mcg + FP
Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
Formoterol 12 mcg
Formoterol 12 mcg one inhalation twice daily, via dry powder inhaler
Fluticasone propionate 100 mcg
Fluticasone propionate 100 mcg one inhalation twice daily via dry powder inhaler
Fluticasone propionate 250 mcg
Fluticasone propionate 250 mcg one inhalation twice daily via dry powder inhaler
Fluticasone propionate 500 mcg
Fluticasone propionate 500 mcg, one inhalation twice daily via dry powder inhaler
fluticasone propionate (FP)
fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
Fluticasone propionate 100 mcg
Fluticasone propionate 100 mcg one inhalation twice daily via dry powder inhaler
Fluticasone propionate 250 mcg
Fluticasone propionate 250 mcg one inhalation twice daily via dry powder inhaler
Fluticasone propionate 500 mcg
Fluticasone propionate 500 mcg, one inhalation twice daily via dry powder inhaler
Placebo
Placebo to match formoterol one inhalation twice daily via dry powder inhaler
Interventions
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Formoterol 12 mcg
Formoterol 12 mcg one inhalation twice daily, via dry powder inhaler
Fluticasone propionate 100 mcg
Fluticasone propionate 100 mcg one inhalation twice daily via dry powder inhaler
Fluticasone propionate 250 mcg
Fluticasone propionate 250 mcg one inhalation twice daily via dry powder inhaler
Fluticasone propionate 500 mcg
Fluticasone propionate 500 mcg, one inhalation twice daily via dry powder inhaler
Placebo
Placebo to match formoterol one inhalation twice daily via dry powder inhaler
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female patients 12 years of age and older
3. 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.
4. PEF≥50% of predicted normal value.
5. Current and appropriate use of one of the treatments listed in the protocol for asthma.
6. 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)
Exclusion Criteria
2. Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other respiratory abnormalities other than asthma.
3. Current evidence of, or past physician assessment of, chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.
4. History of smoking ≥ 10 pack years.
5. Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine.
6. Suspected or documented bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved at randomization.
7. Worsening/Unstable asthma within 7 days prior to randomization.
8. Any asthma exacerbation requiring systemic corticosteroids within 30 days of randomization or more than 4 separate exacerbations in the 12 months preceding randomization.
9. Two or more hospitalizations for greater than 24 hours duration for treatment of asthma in the 12 months preceding randomization.
10. 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.
11. Use of anti-IgE (e.g., omalizumab) or any other monoclonal antibody, in the 6 months prior to randomization.
12. Use of (Beta) β-blockers within 1 day prior to first dose of study medication.
13. Use of ICS, LABA, ICS+LABA, LTRAs, leukotriene modifiers, anticholinergics, or theophylline must be discontinued prior to the first dose of investigational treatment.
14. Use of a potent CYP3A4 inhibitor within 4 weeks of randomization (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin).
12 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Chrsitopher Compton
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Avondale, Arizona, United States
Novartis Investigative Site
North Hollywood, California, United States
Novartis Investigative Site
Bradenton, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Conyers, Georgia, United States
Novartis Investigative Site
Stone Mountain, Georgia, United States
Novartis Investigative Site
Louisville, Kentucky, United States
Novartis Investigative Site
Louisville, Kentucky, United States
Novartis Investigative Site
Covington, Louisiana, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Gaithersburg, Maryland, United States
Novartis Investigative Site
Picayune, Mississippi, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
North Massapequa, New York, United States
Novartis Investigative Site
Elizabeth City, North Carolina, United States
Novartis Investigative Site
Winston-Salem, North Carolina, United States
Novartis Investigative Site
Cleveland, Ohio, United States
Novartis Investigative Site
Oaks, Pennsylvania, United States
Novartis Investigative Site
East Greenwich, Rhode Island, United States
Novartis Investigative Site
Mt. Pleasant, South Carolina, United States
Novartis Investigative Site
Memphis, Tennessee, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
St. George, Utah, United States
Novartis Investigative Site
Mequon, Wisconsin, United States
Novartis Investigative Site
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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2012-004854-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CFOR258D2416
Identifier Type: -
Identifier Source: org_study_id
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