Study of Safety of Foradil in Patients With Persistent Asthma

Persistent Asthma Clinical Trial

Official title:

A 26 Week, Randomized, Active-controlled Safety Study of Double-blind Formoterol Fumarate in Free Combination With an Inhaled Corticosteroid Versus an Inhaled Corticosteroid in Adolescent and Adult Patients With Persistent Asthma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845025
• Other study ID #: CFOR258D2416
• Status: Completed
• Phase: Phase 4
• First received: April 22, 2013
• Last updated: September 28, 2016
• Start date: May 2013
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in adolescents and adults (12 years of age and older) taking inhaled formoterol fumarate/fluticasone propionate combination is the same as those taking inhaled fluticasone propionate alone.

Description:

This is 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 patients with persistent asthma. The primary objective of the study is to demonstrate that the addition of formoterol fumarate to fluticasone propionate is non-inferior to fluticasone propionate alone in terms of the risk of composite serious asthma related events (asthma-related hospitalization, asthma-related intubation, and asthma-related death). The individual components of the composite primary endpoint (i.e., asthma-related hospitalization, asthma-related intubation and asthma-related death) will be assessed as a secondary safety endpoints.

The efficacy assessment is the secondary objective.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 827
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Written informed consent, and assent if applicable, must be obtained before any assessment is performed.

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:

1. History of life-threatening asthma episode that required intubation and/or was associated with hypercapnia requiring non-invasive ventilatory support.

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) ß-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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Persistent Asthma

Intervention

Drug:
• Formoterol
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 formoterol one inhalation twice daily via dry powder inhaler

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Akron	Ohio
United States	Novartis Investigative Site	Albany	Georgia
United States	Novartis Investigative Site	Amarillo	Texas
United States	Novartis Investigative Site	Arlington	Texas
United States	Novartis Investigative Site	Arlington	Virginia
United States	Novartis Investigative Site	Avondale	Arizona
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Beaumont	Texas
United States	Novartis Investigative Site	Bellingham	Washington
United States	Novartis Investigative Site	Belzoni	Mississippi
United States	Novartis Investigative Site	Blackwood	New Jersey
United States	Novartis Investigative Site	Bowling Green	Kentucky
United States	Novartis Investigative Site	Bradenton	Florida
United States	Novartis Investigative Site	Bridgeport	Connecticut
United States	Novartis Investigative Site	Bristol	Tennessee
United States	Novartis Investigative Site	Brookfield	Wisconsin
United States	Novartis Investigative Site	Burke	Virginia
United States	Novartis Investigative Site	Centennial	Colorado
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Clearwater	Florida
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Colorado Springs	Colorado
United States	Novartis Investigative Site	Columbia	Maryland
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Conyers	Georgia
United States	Novartis Investigative Site	Cordova	Tennessee
United States	Novartis Investigative Site	Covington	Louisiana
United States	Novartis Investigative Site	Crowley	Louisiana
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	East Greenwich	Rhode Island
United States	Novartis Investigative Site	East Providence	Rhode Island
United States	Novartis Investigative Site	Elizabeth City	North Carolina
United States	Novartis Investigative Site	Elkhorn	Nebraska
United States	Novartis Investigative Site	Erie	Pennsylvania
United States	Novartis Investigative Site	Eugene	Oregon
United States	Novartis Investigative Site	Evanston	Illinois
United States	Novartis Investigative Site	Everett	Washington
United States	Novartis Investigative Site	Fair Oaks	California
United States	Novartis Investigative Site	Fort Lauderdale	Florida
United States	Novartis Investigative Site	Fredericksburg	Virginia
United States	Novartis Investigative Site	Gaithersburg	Maryland
United States	Novartis Investigative Site	Gastonia	North Carolina
United States	Novartis Investigative Site	Germantown	Tennessee
United States	Novartis Investigative Site	Glendale	Arizona
United States	Novartis Investigative Site	Glendale	Arizona
United States	Novartis Investigative Site	Gonzales	Texas
United States	Novartis Investigative Site	Gresham	Oregon
United States	Novartis Investigative Site	Hartford	Connecticut
United States	Novartis Investigative Site	Hawaiian Gardens	California
United States	Novartis Investigative Site	Hialeah	Florida
United States	Novartis Investigative Site	Huntersville	North Carolina
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Jefferson Hills	Pennsylvania
United States	Novartis Investigative Site	Knoxville	Tennessee
United States	Novartis Investigative Site	Lampasas	Texas
United States	Novartis Investigative Site	Long Beach	California
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Madera	California
United States	Novartis Investigative Site	Manassas	Virginia
United States	Novartis Investigative Site	Marion	Ohio
United States	Novartis Investigative Site	Maumee	Ohio
United States	Novartis Investigative Site	Memphis	Tennessee
United States	Novartis Investigative Site	Memphis	Tennessee
United States	Novartis Investigative Site	Memphis	Tennessee
United States	Novartis Investigative Site	Memphis	Tennessee
United States	Novartis Investigative Site	Memphis	Tennessee
United States	Novartis Investigative Site	Mequon	Wisconsin
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Milwaukee	Wisconsin
United States	Novartis Investigative Site	Milwaukee	Wisconsin
United States	Novartis Investigative Site	Mount Pleasant	South Carolina
United States	Novartis Investigative Site	New Orleans	Louisiana
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	North Charleston	South Carolina
United States	Novartis Investigative Site	North Hollywood	California
United States	Novartis Investigative Site	North Massapequa	New York
United States	Novartis Investigative Site	North Miami Beach	Florida
United States	Novartis Investigative Site	Northfield	New Jersey
United States	Novartis Investigative Site	Oaks	Pennsylvania
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Opelousas	Louisiana
United States	Novartis Investigative Site	Orlando	Florida
United States	Novartis Investigative Site	Palmdale	California
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Picayune	Mississippi
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Port Orange	Florida
United States	Novartis Investigative Site	Rochester	New York
United States	Novartis Investigative Site	Rochester	Minnesota
United States	Novartis Investigative Site	Saint George	Utah
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	Scottsdale	Arizona
United States	Novartis Investigative Site	Shelby	North Carolina
United States	Novartis Investigative Site	Simpsonville	South Carolina
United States	Novartis Investigative Site	Skokie	Illinois
United States	Novartis Investigative Site	Stamford	Connecticut
United States	Novartis Investigative Site	Stone Mountain	Georgia
United States	Novartis Investigative Site	Sunset	Louisiana
United States	Novartis Investigative Site	Tamarac	Florida
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	Tulsa	Oklahoma
United States	Novartis Investigative Site	Tyler	Texas
United States	Novartis Investigative Site	Varnville	South Carolina
United States	Novartis Investigative Site	Warwick	Rhode Island
United States	Novartis Investigative Site	Waukesha	Wisconsin
United States	Novartis Investigative Site	Wichita	Kansas
United States	Novartis Investigative Site	Wilmington	North Carolina
United States	Novartis Investigative Site	Winston Salem	North Carolina
United States	Novartis Investigative Site	Woodbridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined serious asthma related events	Combined number of asthma-related hospitalization, asthma-related intubation, and asthma-related death.	26 weeks	Yes
Secondary	Asthma-related hospitalization	Number of asthma-related hospitalizations.	26 weeks	Yes
Secondary	Asthma-related intubation	Number of asthma-related intubation events	26 weeks	Yes
Secondary	Asthma-related deaths	Number of asthma-related deaths	26 weeks	Yes
Secondary	Rescue medication use	Frequency of rescue medication use during study period	26 weeks	No
Secondary	Symptom and rescue-free days	Number of symptom and rescue-free days per patient	26 weeks	No
Secondary	Nighttime awakenings	Number of nighttime awakenings per patient	26 weeks	No
Secondary	Asthma control Questionnaire (ACQ - 6) score	Change in Asthma control Questionnaire (ACQ - 6) score from baseline	baseline and 26 weks	No