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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01576718




Registration number
NCT01576718
Ethics application status
Date submitted
10/04/2012
Date registered
12/04/2012
Date last updated
8/05/2018

Titles & IDs
Public title
A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications
Scientific title
A 12-Week Dose-ranging Study to Evaluate the Efficacy and Safety of Fp Spiromax® (Fluticasone Propionate Inhalation Powder) Administered Twice Daily Compared With Placebo in Adolescent and Adult Subjects With Severe Persistent Asthma Uncontrolled on High Dose Inhaled Corticosteroid Therapy
Secondary ID [1] 0 0
2010-023601-35
Secondary ID [2] 0 0
FpS-AS-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fp MDPI
Other interventions - Placebo MDPI
Treatment: Drugs - Flovent Diskus
Treatment: Drugs - albuterol/salbutamol

Experimental: Fp MDPI 50 mcg - Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.

Experimental: Fp MDPI 100 mcg - Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.

Experimental: Fp MDPI 200 mcg - Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.

Experimental: Fp MDPI 400 mcg - Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.

Placebo Comparator: Placebo MDPI - Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.

Active Comparator: Flovent Diskus 250mcg - Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.


Treatment: Drugs: Fp MDPI
Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.
During the treatment period, participants were randomized to 50, 100, 200 or 400 mcg of Fp one inhalation twice a day for a total daily dose of 100, 200, 400 or 800 mcg. Study drug was administered in the morning and in the evening.

Other interventions: Placebo MDPI
Placebo multidose dry powder inhaler (MDPI) in the morning and evening. Placebo MDPI was provided in devices identical in appearance to Fp MDPI.

Treatment: Drugs: Flovent Diskus
Flovent Diskus contains the active ingredient fluticasone propionate (Fp). Flovent Diskus 250 mcg was used twice a day, once in the morning and evening, for a total daily dose of 500 mcg of Fp. This therapy was not blinded as the inhaler device was different than the MDPI used in the other treatment arms.

Treatment: Drugs: albuterol/salbutamol
A short-acting ß2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period
Timepoint [1] 0 0
Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12
Secondary outcome [1] 0 0
Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period
Timepoint [1] 0 0
Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12
Secondary outcome [2] 0 0
Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period
Timepoint [2] 0 0
Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12
Secondary outcome [3] 0 0
The Kaplan-Meier Estimate Of The Probability Of Remaining In The Study At Week 12
Timepoint [3] 0 0
Day 1 to Week 12
Secondary outcome [4] 0 0
Change From Baseline In The Percentage Of Rescue-Free 24-Hour Periods
Timepoint [4] 0 0
Baseline (Day -6 to Day 1 predose), Treatment (Day 1 to Week 12)
Secondary outcome [5] 0 0
Area Under The Plasma Concentration-Time Curve From Time Zero To The Time Of The Last Measurable Concentration (AUC0-t)
Timepoint [5] 0 0
Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose
Secondary outcome [6] 0 0
Maximum Observed Plasma Concentration (Cmax)
Timepoint [6] 0 0
Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose
Secondary outcome [7] 0 0
Time Of Maximum Observed Plasma Concentration (Tmax)
Timepoint [7] 0 0
Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose
Secondary outcome [8] 0 0
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
Timepoint [8] 0 0
Day 1 to Week 12
Secondary outcome [9] 0 0
Patients With Positive Swab Test Results for Oral Candidiasis
Timepoint [9] 0 0
Screening (Days -21 to -14), Randomization (Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12
Secondary outcome [10] 0 0
24-Hour Urinary Cortisol Excretion at Baseline, Week 12 and Endpoint
Timepoint [10] 0 0
Baseline (Day 1), Week 12, Endpoint

Eligibility
Key inclusion criteria
1. Written informed consent/assent signed and dated by the subject and/or parent /legal
guardian before conducting any study related procedure.

2. Male or female 12 years and older, as of the Screening Visit. Male or female 18 years
and older, as of the Screening Visit, in countries where local regulations or the
regulatory status of study medication permit enrollment of adults only.

3. General good health, and free of any concomitant conditions or treatment that could
interfere with study conduct, influence the interpretation of study
observations/results, or put the subject at increased risk during the study.

4. Asthma Diagnosis: Asthma as defined by the National Institutes of Health (NIH).

5. Severity of Disease:

• A best forced expiratory volume in one second (FEV1) of 40%-85% of the predicted
normal value during the Screening Visit. NHANES III predicted values will be used for
subjects aged =12 years and adjustments to predicted values will be made for African
American subjects. ATS/ERS 2005 criteria for acceptability, reproducibility, and end
of test must be met for spirometry

6. Reversibility of Disease: Demonstrated a =12% reversibility of FEV1 within 30 minutes
following 2 inhalations of albuterol/salbutamol inhalation aerosol (if required,
spacers are permitted for reversibility testing only) at the Screening Visit. If a
subject fails to demonstrate an increase in FEV1 =12% then the subject is not eligible
for the study and will not be allowed to re-screen. Reversibility values of 11.50 -
11.99 will be rounded to 12. Documented historical reversibility of = 12 % within 3
months of the Screening Visit will be accepted.

7. Current Asthma Therapy: Subjects will be required to be on a short acting ß2 agonist
and inhaled corticosteroid for a minimum of 8 weeks before the Screening Visit and
have been maintained on a stable dose of inhaled corticosteroids for four weeks prior
to the Screening Visit at one of the following doses:

- Fluticasone propionate HFA MDI = 880 mcg/day

- Fluticasone propionate DPI= 1000 mcg/day

- Beclomethasone dipropionate DPI = 2000 mcg/day

- Beclomethasone dipropionate HFA (QVAR)= 640 mcg/day

- Beclomethasone dipropionate HFA (Clenil Modulite)= 2000 mcg/day

- Budesonide DPI = 1600 mcg/day

- Budesonide MDI = 1600 mcg/day

- Flunisolide = 2000 mcg/day

- Triamcinolone acetonide = 2000 mcg /day

- Mometasone furoate DPI = 880 mcg/day

- Ciclesonide HFA MDI = 640 mcg/day

Exception 1: Based upon the investigator's judgment that there is no inherent harm in
changing the subject's current ICS/LABA therapy and the subject provides consent,
subjects on inhaled Fluticasone propionate/salmeterol DPI = 1000 mcg/day, or
Fluticasone propionate/salmeterol HFA = 880 mcg/day, or Fluticasone
propionate/Formoterol = 1000 mcg/day,or Beclomethasone dipropionate/Formoterol = 400
mcg/day, or Budesonide/formoterol HFA = 640 mcg/day, or Budesonide/formoterol DPI =
800 mcg/day, or Mometasone furoate/formoterol MDI = 800 mcg/day or subjects on a
qualifying ICS dose plus a long-acting ß2-agonists (LABA) administered via separate
inhalers, may be switched to a qualifying dose of fluticasone propionate provided the
subjects will not participate in the PK portion of the study.

Exception 2: Subjects on a qualifying dose of fluticasone propionate who wish to
participate in the PK portion of the study and who provide consent may have their
fluticasone propionate switched to a different qualifying ICS (non-fluticasone
propionate) at a pre-screening visit. The subject will be required to return to the
clinic to complete the Screening Visit following a 1-week washout period.

8. Short-Acting ß2-Agonists: All subjects must be able to replace their current
short-acting ß2-agonists with albuterol/salbutamol inhalation aerosol at the Screening
Visit for use as needed for the duration of the study. The use of spacer devices with
the metered dose inhaler (MDI) will not be allowed during the study with exception of
it's use during reversibility testing at the Screening Visit. Nebulized
albuterol/salbutamol will not be allowed at any time during the study. Subjects must
be able to withhold all inhaled short-acting ß2 sympathomimetic bronchodilators for at
least 6 hours prior to all study visits.

9. If female, is currently not pregnant, breast feeding, or attempting to become
pregnant, has a negative serum pregnancy test, and is of

- Non-childbearing potential, defined as:

- Before menarche, or

- 1 year post-menopausal, or

- Surgically sterile (tubal ligation, bilateral oophorectomy, or
hysterectomy), or

- Congenital sterility, or

- Diagnosed as infertile and not undergoing treatment to reverse infertility
or is of

- Child-bearing potential, willing to commit to using a consistent and acceptable
method of birth control as defined below for the duration of the study:

- Systemic contraception used for 1 month prior to screening, including birth
control pills, transdermal patch (Ortho Evra®), vaginal ring (NuvaRing®),
levonorgesterel (Norplant®), or injectable progesterone (Depo-Provera®), or

- Double barrier methods (condoms, cervical cap, diaphragm, and vaginal
contraceptive film with spermicide), or

- Intrauterine device (IUD) or

- Monogamous with a vasectomized male partner or is of

- Child-bearing potential and not sexually active, willing to commit to using a
consistent and acceptable method of birth control as defined above for the
duration of the study, in the event the subject becomes sexually active

10. Capable of understanding the requirements, risks, and benefits of study participation,
and, as judged by the investigator, capable of giving informed consent/assent and
being compliant with all study requirements (visits, record-keeping, etc).
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of life-threatening asthma that is defined for this protocol as an asthma
episode that required intubation and/or was associated with hypercapnea, respiratory
arrest or hypoxic seizures.

2. Culture-documented or suspected bacterial or viral infection of the upper or lower
respiratory tract, sinus, or middle ear that is not resolved within 2 weeks of the
Screening Visit. In addition, the subject must be excluded if such infection occurs
between the Screening Visit and the Randomization Visit.

3. Any asthma exacerbation requiring oral corticosteroids within 1 month of the Screening
Visit. A subject must not have had any hospitalization for asthma within 2 month prior
to the Screening Visit.

Note: An exacerbation of asthma is defined as any worsening of asthma requiring any
treatment other than rescue albuterol/salbutamol HFA MDI and/or the subject's regular
inhaled corticosteroid maintenance treatment. This includes requiring the use of
systemic corticosteroids and/or emergency room visit or hospitalization, a change in
the subject's regular inhaled corticosteroid maintenance treatment, or the addition of
other asthma medications.

4. Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal
cell carcinoma.

5. Historical or current evidence of a clinically significant disease including, but not
limited to: cardiovascular (e.g., congestive heart failure, known aortic aneurysm,
clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal,
hematological, neuropsychological, endocrine (e.g., uncontrolled diabetes mellitus,
uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome),
gastrointestinal (e.g., poorly-controlled peptic ulcer, GERD), or pulmonary (e.g.,
chronic bronchitis, emphysema, bronchiectasis with the need for treatment, cystic
fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease).
Significant is defined as any disease that, in the opinion of the investigator, would
put the safety of the subject at risk through participation, or which could affect the
efficacy or safety analysis if the disease/condition exacerbated during the study.

6. Have any of the following conditions that, in the judgment of the investigator, might
cause participation in this study to be detrimental to the subject, including, but not
limited to:

- Current malignancy excluding basal cell carcinoma; History of malignancy is
acceptable only if the subject has been in remission for one year prior to the
Screening Visit. (Remission is defined as no current evidence of malignancy and
no treatment for the malignancy in the 12 months prior to the Screening Visit)

- Current or untreated tuberculosis; History of tuberculosis is acceptable only if
a subject has received an approved prophylactic treatment regimen or an approved
active treatment regimen and has had no evidence of active disease for a minimum
of 2 years

- Uncontrolled hypertension (systolic BP =160 or diastolic BP >100)

- Stroke within 3 months prior to the Screening Visit

- Immunologic compromise

7. History of a positive test for HIV, hepatitis B or hepatitis C infection.

8. Untreated oral candidiasis at the Screening Visit. Subjects with clinical visual
evidence of oral candidiasis and who agree to receive treatment and comply with
appropriate medical monitoring may enter the study

9. History of any adverse reaction to any intranasal, inhaled or systemic corticosteroid
therapy. Known or suspected sensitivity to the constituents of the dry powder inhalers
(Spiromax or Diskus) used in the study (i.e., lactose).

10. History of severe allergy to milk protein.

11. Use of systemic, oral or depot corticosteroids within 4 weeks prior to the Screening
Visit

- Use of topical corticosteroids (=1% hydrocortisone cream) for dermatological
disease is permitted

- Use of intranasal corticosteroids or ocular corticosteroids at a stable dose for
at least 4 weeks prior to the Screening Visit and throughout the study is
permitted

12. Use of immunosuppressive medications within 4 weeks prior to the Screening Visit and
during the study.

13. Immunotherapy for the treatment of allergy at a stable maintenance dose for at least
90 days prior to the Screening Visit and which will remain at a stable dose without
escalation throughout the study is permitted.

14. Use of Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole,
itraconazole) within 4 weeks prior to the Screening Visit. Strong and moderate CYP3A4
inhibitors are prohibited and weak CYP3A4 are allowed.

15. History of alcohol or drug abuse within two years preceding the Screening Visit.

16. Current smoker or a smoking history of 10 pack years or more (a pack year is defined
as smoking 1 pack of cigarettes/day for 1 year). A subject may not have used tobacco
products within the past one year (e.g., cigarettes, cigars, chewing tobacco, or pipe
tobacco).

17. Study participation by clinical investigator site employees and/or their immediate
relatives.

18. Study participation by more than one subject from the same household at the same time.
However, after the study completion or discontinuation by one subject another subject
from the same household may be screened.

19. Participation in any investigational drug study within the 30 days (starting at the
final follow-up visit) preceding the Screening Visit or planned participation in
another investigational drug study at any time during this study.

20. Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for
in vitro fertilization during the study period or for 30 days following the subject's
last study related visit (for eligible subjects only - if applicable). Eligible female
subjects unwilling to employ appropriate contraceptive measures to ensure that
pregnancy will not occur during the study will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
889
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Teva Investigational Site 85570 - Bedford Park
Recruitment hospital [2] 0 0
Teva Investigational Site 85571 - Parkville
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Parkville
Recruitment outside Australia
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United States of America
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Alabama
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Bulgaria
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Burgas
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Canada
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Croatia
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Larissa
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Israel
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Israel
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Kfar Saba
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Israel
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Israel
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Watford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Teva Branded Pharmaceutical Products R&D, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to evaluate the dose response, efficacy and safety of
4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as
Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in
subjects 12 years of age and older with severe persistent asthma who are uncontrolled on high
dose ICS therapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01576718
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01576718