An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol (FF/VI) 200/25 Microgram (mcg) , FF/VI 100/25 mcg, and FF 100 mcg in Adults and Adolescents With Persistent Asthma.
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 1/26/2018 |
Start Date: | September 20, 2012 |
End Date: | October 15, 2013 |
A Randomized, Double-Blind, Parallel Group, Multicenter Study of Fluticasone Furoate/Vilanterol 200/25 mcg Inhalation Powder, Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, and Fluticasone Furoate 100 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents
This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study
with three active comparators in subjects with moderate to severe persistent asthma. The
study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks, and
a follow up contact period of one week. The total duration of the study is 17 weeks. 990
subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg
once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF
100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects will
be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for acute
asthma symptoms throughout the entire study. Subjects will attend four on-treatment visits at
Weeks 2, 4, 8, and 12 (Visits 4 through 7).
with three active comparators in subjects with moderate to severe persistent asthma. The
study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks, and
a follow up contact period of one week. The total duration of the study is 17 weeks. 990
subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg
once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF
100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects will
be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for acute
asthma symptoms throughout the entire study. Subjects will attend four on-treatment visits at
Weeks 2, 4, 8, and 12 (Visits 4 through 7).
Inclusion Criteria:
- Subjects must give their signed and dated (written) informed consent to participate.
Written informed consent must be obtained if a subject's current medication is changed
as a result of study participation
- Outpatient >=12 years of age at Visit 1 who have had a diagnosis of asthma, as defined
by the National Institutes of Health. Countries with local restrictions prohibiting
enrolment of adolescents will only enroll subjects >=18 years of age
- Male or an eligible female. Eligible female is defined as having non-childbearing
potential or having childbearing potential and using an acceptable method of birth
control consistently and correctly.
- Best pre-bronchodilator FEV1 of 40% to 80% of their predicted normal value.
- Demonstrate >=12% and >=200 mL reversibility of FEV1 within 10 to 40 minutes following
4 inhalations of albuterol/salbutamol inhalation aerosol (or an equivalent nebulized
treatment with albuterol/salbutamol solution) or have documented reversibility testing
within the 6 months prior to Visit 1 meeting this measure of reversibility. A spacer
device may be used for testing, if required.
- If subject have received ICS for at least 12 weeks prior to Visit 1 and their
treatment during the 4 weeks immediately prior to Visit 1 consisted of either of the
two regimens (a or b).a.) A stable mid-dose or high-dose of ICS alone (e.g., >=FP 250
mcg twice daily) or b.) A stable dose of a mid-dose ICS/LABA combination (e.g.,
FP/Salmeterol [SALM] 250/50 mcg twice daily) or an equivalent combination via separate
inhalers.
- Use of ICS/LABA are not permitted with LABA on the day of Visit 1.
- Must be able to replace current SABA treatment with albuterol/salbutamol aerosol
inhaler at Visit 1 for use as needed, during the study. Subjects must be able to
withhold albuterol/salbutamol for at least 6 hours prior to study visits
Exclusion Criteria:
- History of life-threatening asthma, defined as an asthma episode that required
intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic
seizures within the last 5 years.
- Upper or lower respiratory tract, sinus, or middle ear that is: not resolved within 4
weeks of Visit 1 and led to a change in asthma management or, in the opinion of the
investigator, expected to affect the subject's asthma status or the subject's ability
to participate in the study.
- Any asthma exacerbation that required oral corticosteroids within the 12 weeks prior
to Visit 1 or, resulted in an overnight hospitalization requiring additional treatment
for asthma within 6 months prior to Visit 1.
- A subject must not have current evidence of atelectasis (segmental or larger),
bronchopulmonary dysplasia, chronic obstructive pulmonary disease, Or any evidence of
concurrent respiratory disease other than asthma
- A subject must not have any clinically significant, uncontrolled condition or disease
state that, in the opinion of the investigator, would put the safety of the subject at
risk through study participation or would confound the interpretation of the efficacy
results if the condition/disease exacerbated during the study
- Chronic stable hepatitis B or C are acceptable provided their screening alanine
transaminase (ALT) is <2x upper limit of normal (ULN) and the y otherwise meet the
entry criteria. Chronic co-infection with both hepatitis B and hepatitis C are not
eligible
- Clinical visual evidence of candidiasis at Visit 1
- Use of any investigational drug within 30 days prior to Visit 1 or within five
half-lives (t½), whichever is longer of the two.
- Allergies to drug or milk protein: any adverse reaction, to any beta2-agonist,
sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy
or known or suspected sensitivity to the constituents of the NDPI, or history of
severe milk protein allergy
- Administration of medication that would significantly affect the course of asthma, or
interact with study drug
- Use of immunosuppressive medications during the study.
- Use of potent CYP3A4 inhibitor within 4 weeks of Visit 1.
- A subject or his/her parent or legal guardian has any infirmity, disability, disease,
or resides in a geographical location which seems likely, in the opinion of the
Investigator, to impair compliance with any aspect of this study protocol, including
visit schedule, and completion of the daily diaries.
- Current smoker or has a smoking history of 10 pack-years (20 cigarettes/day for 10
years). A subject may not have used inhaled tobacco products within the past 3 months
(i.e., cigarettes, cigars, or pipe tobacco).
- If subject is an immediate family member of the participating investigator,
sub-investigator, study coordinator, or employee of the participating investigator.
- Subject previously randomized to treatment with FF/VI or FF in another Phase III study
- Subjects working on night shift a week prior to Visit 1 or during the study period.
- Adolescents who are wards of the state or government
We found this trial at
37
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