Study of Safety of Foradil in Patients With Persistent Asthma

NCT01845025 | Terminated Phase 4 Results DMC

• 2 other identifiers: CFOR258D24162012-004854-27
• Study Type: interventional
• Target: 827
• Locations: 1 country
• Sites: 27

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 adults (12 years of age and older) taking inhaled formoterol fumarate/fluticasone propionate combination was the same as those taking inhaled fluticasone propionate alone.

Conditions

Persistent Asthma

Keywords

Asthma; formoterol fumarate; Foradil; inhaled corticosteroid; fluticasone propionate; safety

Outcome Measures

Primary Outcomes (1)

• Number of First Occurrence(s) of Any Composite Endpoint Including Asthma-related Hospitalizations, Intubations and Deaths During the Study at 26 Weeks

  The primary safety endpoint was the number of first occurrence(s) of any composite endpoint. The composite events include asthma-related deaths, asthma-related intubations and asthma-related hospitalizations. The number of events includes all adjudication confirmed events, one patient could experience multiple events during the course of study; Event rate = 100 \* n patients with any events / total N patients in treatment group.

  26 weeks

Secondary Outcomes (8)

• Number of Asthma Exacerbations at 26 Weeks

  26 weeks

• Percentage of Days of School/Work Missed at 26 Weeks

  26 weeks

• Percentage of Days With Limited Ability to Perform Normal Daily Activities at 26 Weeks

  26 weeks

• Percentage of Days With Nighttime Awakenings at 26 Weeks

  26 weeks

• Percentage of Days With no Rescue Medication Use at 26 Weeks

  26 weeks

Study Arms (2)

FOM 12 mcg + FP

EXPERIMENTAL

Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation

Drug: Formoterol 12 mcg; Drug: Fluticasone propionate 100 mcg; Drug: Fluticasone propionate 250 mcg; Drug: Fluticasone propionate 500 mcg

fluticasone propionate (FP)

ACTIVE COMPARATOR

fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation

Drug: Fluticasone propionate 100 mcg; Drug: Fluticasone propionate 250 mcg; Drug: Fluticasone propionate 500 mcg; Drug: Placebo

Interventions

Formoterol 12 mcg DRUG

Formoterol 12 mcg one inhalation twice daily, via dry powder inhaler

Also known as: FOR258

FOM 12 mcg + FP

Fluticasone propionate 100 mcg DRUG

Fluticasone propionate 100 mcg one inhalation twice daily via dry powder inhaler

FOM 12 mcg + FP; fluticasone propionate (FP)

Fluticasone propionate 250 mcg DRUG

Fluticasone propionate 250 mcg one inhalation twice daily via dry powder inhaler

FOM 12 mcg + FP; fluticasone propionate (FP)

Fluticasone propionate 500 mcg DRUG

Fluticasone propionate 500 mcg, one inhalation twice daily via dry powder inhaler

FOM 12 mcg + FP; fluticasone propionate (FP)

Placebo DRUG

Placebo to match formoterol one inhalation twice daily via dry powder inhaler

fluticasone propionate (FP)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (27)

Novartis Investigative Site

Avondale, Arizona, 85323, United States

Location

Novartis Investigative Site

North Hollywood, California, 91606, United States

Location

Novartis Investigative Site

Bradenton, Florida, 34209, United States

Location

Novartis Investigative Site

Miami, Florida, 33126, United States

Location

Novartis Investigative Site

Miami, Florida, 33134, United States

Location

Novartis Investigative Site

Conyers, Georgia, 30012, United States

Location

Novartis Investigative Site

Stone Mountain, Georgia, 30083, United States

Location

Novartis Investigative Site

Louisville, Kentucky, 40214, United States

Location

Novartis Investigative Site

Louisville, Kentucky, 40220, United States

Location

Novartis Investigative Site

Covington, Louisiana, 70433, United States

Location

Novartis Investigative Site

Baltimore, Maryland, 21287, United States

Location

Novartis Investigative Site

Gaithersburg, Maryland, 20878, United States

Location

Novartis Investigative Site

Picayune, Mississippi, 39466, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63117, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63128, United States

Location

Novartis Investigative Site

North Massapequa, New York, 11758, United States

Location

Novartis Investigative Site

Elizabeth City, North Carolina, 27909, United States

Location

Novartis Investigative Site

Winston-Salem, North Carolina, 27103, United States

Location

Novartis Investigative Site

Cleveland, Ohio, 44106-5000, United States

Location

Novartis Investigative Site

Oaks, Pennsylvania, 19456, United States

Location

Novartis Investigative Site

East Greenwich, Rhode Island, 02818, United States

Location

Novartis Investigative Site

Mt. Pleasant, South Carolina, 29464, United States

Location

Novartis Investigative Site

Memphis, Tennessee, 38118, United States

Location

Novartis Investigative Site

Dallas, Texas, 75235, United States

Location

Novartis Investigative Site

St. George, Utah, 84790, United States

Location

Novartis Investigative Site

Mequon, Wisconsin, 53092, United States

Location

Novartis Investigative Site

Milwaukee, Wisconsin, 53172, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Formoterol Fumarate; Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Chrsitopher Compton

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: May 3, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 21, 2017
• Results First Posted: March 21, 2017

Record last verified: 2017-01

Locations

US (27)