Persistent AsthmaPhase 4NCT01845025
Study of Safety of Foradil in Patients With Persistent Asthma
A Phase 4 study testing Formoterol 12 mcg, Fluticasone propionate 100 mcg and Fluticasone propionate 250 mcg in people with Persistent Asthma, run by Novartis Pharmaceuticals at 27 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Persistent Asthma
- What is being tested?
- Formoterol 12 mcg, Fluticasone propionate 100 mcg and Fluticasone propionate 250 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 827 participants
- Where
- 27 sitesUnited States
- Study dates
- May 2013to May 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 14Show fewer
- 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).
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Novartis Investigative Site
Avondale, Arizona, 85323
Novartis Investigative Site
Baltimore, Maryland, 21287
Novartis Investigative Site
Bradenton, Florida, 34209
Novartis Investigative Site
Cleveland, Ohio, 44106-5000
Novartis Investigative Site
Conyers, Georgia, 30012
Novartis Investigative Site
Covington, Louisiana, 70433
Novartis Investigative Site
Dallas, Texas, 75235
Novartis Investigative Site
East Greenwich, Rhode Island, 02818
Novartis Investigative Site
Elizabeth City, North Carolina, 27909
Novartis Investigative Site
Gaithersburg, Maryland, 20878
Novartis Investigative Site
Louisville, Kentucky, 40214
Novartis Investigative Site
Louisville, Kentucky, 40220
Novartis Investigative Site
Memphis, Tennessee, 38118
Novartis Investigative Site
Mequon, Wisconsin, 53092
Novartis Investigative Site
Miami, Florida, 33126
Novartis Investigative Site
Miami, Florida, 33134
Novartis Investigative Site
Milwaukee, Wisconsin, 53172
Novartis Investigative Site
Mt. Pleasant, South Carolina, 29464
Novartis Investigative Site
North Hollywood, California, 91606
Novartis Investigative Site
North Massapequa, New York, 11758
Novartis Investigative Site
Oaks, Pennsylvania, 19456
Novartis Investigative Site
Picayune, Mississippi, 39466
Novartis Investigative Site
St Louis, Missouri, 63117
Novartis Investigative Site
St Louis, Missouri, 63128
Novartis Investigative Site
St. George, Utah, 84790
Novartis Investigative Site
Stone Mountain, Georgia, 30083
Novartis Investigative Site
Winston-Salem, North Carolina, 27103
About this study
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.
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.
Read the 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 patients with persistent asthma. The primary objective of the study was 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.
- Conditions
- Persistent Asthma
- Being tested
- Formoterol 12 mcg, Fluticasone propionate 100 mcg, Fluticasone propionate 250 mcg, Fluticasone propionate 500 mcg, Placebo
- Keywords
- Asthma, formoterol fumarate, Foradil, inhaled corticosteroid, fluticasone propionate, safety
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formoterol 12 mcgDrug
Also called FOR258
Formoterol 12 mcg one inhalation twice daily, via dry powder inhaler
Fluticasone propionate 100 mcgDrug
Fluticasone propionate 100 mcg one inhalation twice daily via dry powder inhaler
Fluticasone propionate 250 mcgDrug
Fluticasone propionate 250 mcg one inhalation twice daily via dry powder inhaler
Fluticasone propionate 500 mcgDrug
Fluticasone propionate 500 mcg, one inhalation twice daily via dry powder inhaler
PlaceboDrug
Placebo to match formoterol one inhalation twice daily via dry powder inhaler
| Study group | Role | What they receive |
|---|---|---|
| FOM 12 mcg + FP | Experimental | Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation Receives: 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 Receives: Drug: Fluticasone propionate 100 mcg; Drug: Fluticasone propionate 250 mcg; Drug: Fluticasone propionate 500 mcg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 weeks
Secondary outcomes (8)
Number of Asthma Exacerbations at 26 Weeks
Number of asthma exacerbations events
Measured: 26 weeks
Percentage of Days of School/Work Missed at 26 Weeks
The percentage of days of school/work missed during the treatment period (26 weeks). Overall percentage of school days missed for each student patient or of work days missed is calculated by total number of days missed divided by total days of treatment.
Measured: 26 weeks
Percentage of Days With Limited Ability to Perform Normal Daily Activities at 26 Weeks
The percentage of days with limited ability to perform normal daily activities during the treatment period (26 weeks). Percentage is calculated as total number of days when the patient had limited ability to perform normal daily activities divided by total days of treatment.
Measured: 26 weeks
Percentage of Days With Nighttime Awakenings at 26 Weeks
Percentage of days with nighttime awakenings during the treatment period (26 weeks)
Measured: 26 weeks
Percentage of Days With no Rescue Medication Use at 26 Weeks
Percentage of rescue free days is calculated as total number of days with no rescue medication was taken divided by total days of treatment.
Measured: 26 weeks
Percentage of Days With no Symptoms at 26 Weeks
Percentage of days with no symptoms during the treatment period (26 weeks). Percentage is calculated as total number of days with no symptoms divided by total days of treatment.
Measured: 26 weeks
Change From Baseline in Asthma Control Questionnaire (ACQ - 6) Total Score at Week 26
Change from baseline in Asthma control Questionnaire (ACQ - 6) total score at week 26. Results of the Asthma control questionnaire (ACQ-6); The average score of the six questions is calculated as the sum of scores divided by the number of questions that were answered at the time point, as long as there were at least 4 questions answered. The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a total score of 0 corresponds to no impairment and a total score of 6 corresponds to maximum impairment.
Measured: baseline and 26 weeks
Unplanned Healthcare Utilization at Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 26)
Unplanned healthcare utilization by visit (Telephone contact with study doctor (MD); Telephone contact with other physician (MD) or healthcare provider (HCP); Unscheduled or unplanned visit to study doctor (including home visits); Unscheduled or unplanned visit to other physician or healthcare provider (including home visits); Emergency department or hospital visit (< 24 hours); Hospital admission or Emergency department visit (> 24 hours).
Measured: Week 4, Week 12, and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Due to the action to withdraw the Foradil Aerolizer NDA in US; study was discontinued. This was a commercial reason and not due to any change in benefit-risk.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Persistent AsthmaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 827 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chrsitopher Compton, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845025
- Sponsor's protocol ID
- CFOR258D2416
- Other IDs
- 2012-004854-27
- Status last verified
- Jan 2017
- First submitted
- 22 Apr 2013
- Last updated
- 21 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01845025
- Acronym / sponsor ID
- CFOR258D2416
- Conditions
- Persistent Asthma
- Keywords
- Asthma, formoterol fumarate, Foradil, inhaled corticosteroid, fluticasone propionate, safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the action to withdraw the Foradil Aerolizer NDA in US; study was discontinued. This was a commercial reason and not due to any change in benefit-risk.
- Enrolment
- 827 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Posted 21 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 patients with persistent asthma. The primary objective of the study was 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOM 12 mcg + FP | Experimental | Drug: Formoterol 12 mcg, Drug: Fluticasone propionate 100 mcg, Drug: Fluticasone propionate 250 mcg, Drug: Fluticasone propionate 500 mcgFormoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation |
| fluticasone propionate (FP) | Active comparator | Drug: Fluticasone propionate 100 mcg, Drug: Fluticasone propionate 250 mcg, Drug: Fluticasone propionate 500 mcg, Drug: Placebofluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formoterol 12 mcgAlso: FOR258Formoterol 12 mcg one inhalation twice daily, via dry powder inhaler | Drug | FOM 12 mcg + FP |
| Fluticasone propionate 100 mcgFluticasone propionate 100 mcg one inhalation twice daily via dry powder inhaler | Drug | FOM 12 mcg + FP, fluticasone propionate (FP) |
| Fluticasone propionate 250 mcgFluticasone propionate 250 mcg one inhalation twice daily via dry powder inhaler | Drug | FOM 12 mcg + FP, fluticasone propionate (FP) |
| Fluticasone propionate 500 mcgFluticasone propionate 500 mcg, one inhalation twice daily via dry powder inhaler | Drug | FOM 12 mcg + FP, fluticasone propionate (FP) |
| PlaceboPlacebo to match formoterol one inhalation twice daily via dry powder inhaler | Drug | fluticasone propionate (FP) |
Primary outcome
Number of First Occurrence(s) of Any Composite Endpoint Including Asthma-related Hospitalizations, Intubations and Deaths During the Study at 26 Weeks
Time frame: 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.
8 secondary outcomes
Number of Asthma Exacerbations at 26 Weeks
Time frame: 26 weeks
Percentage of Days of School/Work Missed at 26 Weeks
Time frame: 26 weeks
Percentage of Days With Limited Ability to Perform Normal Daily Activities at 26 Weeks
Time frame: 26 weeks
Percentage of Days With Nighttime Awakenings at 26 Weeks
Time frame: 26 weeks
Percentage of Days With no Rescue Medication Use at 26 Weeks
Time frame: 26 weeks
Percentage of Days With no Symptoms at 26 Weeks
Time frame: 26 weeks
Change From Baseline in Asthma Control Questionnaire (ACQ - 6) Total Score at Week 26
Time frame: baseline and 26 weeks
Unplanned Healthcare Utilization at Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 26)
Time frame: Week 4, Week 12, and Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chrsitopher Compton study director
Novartis Pharmaceuticals
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Formoterol 12 mcg, Fluticasone propionate 100 mcg and Fluticasone propionate 250 mcg in people with Persistent Asthma, run by Novartis Pharmaceuticals at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of First Occurrence(s) of Any Composite Endpoint Including Asthma-related Hospitalizations, Intubations and Deaths During the Study at 26 Weeks (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.