| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10003553 |
| E.1.2 | Term | Asthma |
| E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
To evaluate the efficacy and safety of fluticasone furoate 100mcg administered once
daily in the evening in adolescent and adult subjects 12 years of age and older with
persistent bronchial asthma over a 24 week treatment period. |
|
| E.2.2 | Secondary objectives of the trial |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Informed consent: Subjects must give their signed and dated written informed consent to participate
2. Type of Subject: Outpatients 12 years of age or older at Visit 1 (or ≥18 years of age if local regulations or the regulatory status of study medication permit enrolment of adults only; in Germany: ≥18 years of age) with a diagnosis of asthma as defined by the National Institutes of Health [NIH, 2007] at least 12 weeks prior to Visit 1.
3. Gender: Male or Eligible Female, defined as non-childbearing potential or
childbearing potential using an acceptable method of birth control consistently and
correctly, as defined by the following:
• Male partner who is sterile prior to the female subject’s entry into the study and
is the sole sexual partner for that female subject
• Implants of levonorgestrel, etonogestrel
• Injectable progestogen
• Oral contraceptive (either combined estrogen/progestin or progestin only)
• Any intrauterine device (IUD) with a documented failure rate of less than 1%
per year
• Double barrier method – spermicide plus a mechanical barrier (e.g., spermicide
plus a male condom or a spermicide and female diaphragm).
• Estrogenic vaginal ring
• Percutaneous contraceptive patches
• Females of childbearing potential who are not sexually active must commit to
complete abstinence from intercourse throughout the clinical trial and for a
period after the trial to account for elimination of the drug (minimum of six
days)
• Female subjects should not be enrolled if they are pregnant, lactating or plan to
become pregnant during the time of study participation. A serum pregnancy test
is required for females of childbearing potential at the initial screening visit
(Visit 1) and Visit 9 or Early Withdrawal. In addition a urine pregnancy test
will be performed on all females of childbearing potential at Visits 2 and 6 and a
take-home test will be performed at Visit 10 (Follow up Visit/Contact).
4. Severity of Disease: A best pre-bronchodilator FEV1 of 40%-90% of the predicted
normal value at the Visit 1 screening visit. Predicted values will be based upon
NHANES III [Hankinson, 2010]. If a subject is recorded as having Hispanic or
Latino ethnicity, then the Mexican-American equations will be used (irrespective of
race). If a subject is recorded as being of African-American/African heritage race,
then the African-American equations will be used. If a subject is recorded as being of
Asian race, then the Asian adjustment will be used. Otherwise, the Caucasian
equations will be used.
5. Reversibility of Disease: Demonstrated ≥12% and ≥200mL evening reversibility of
FEV1 within 10-40 minutes following 2-4 inhalations of albuterol/salbutamol
inhalation aerosol (or equivalent nebulized treatment with albuterol/salbutamol
solution) at screening (Visit 1).
6. Current Anti-Asthma Therapy: Subjects must be taking a stable doses of ICS for at least 4
weeks prior to Visit 1.
See Table 1 Page 18 of the protocol for examples of doses of commonly prescribed ICS medication.
7. Short-Acting Beta2-Agonists (SABAs): All subjects must be able to replace their current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit1 for use as
needed for the duration of the study. Subjects must be able to withhold
albuterol/salbutamol for at least 6 hours prior to study visits.
|
|
| E.4 | Principal exclusion criteria |
1. History of Life-threatening asthma: Defined for this protocol as an asthma episode
that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 10 years.
2. Respiratory Infection: Culture-documented or suspected bacterial or viral infection
of the 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, is expected to affect the subject’s asthma status or the subject’s
ability to participate in the study.
3. Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids or
that resulted in overnight hospitalization requiring additional treatment for asthma
within 6 months prior to Visit 1.
4. Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease,
bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive
pulmonary disease, or other respiratory abnormalities other than asthma.
5. Other Concurrent Diseases/Abnormalities: 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 patient at risk through study participation or
would confound the interpretation of the efficacy results if the condition/disease
exacerbated during the study. View protocol for further information.
6. Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she
has clinical visual evidence of candidiasis at Visit 1.
7. Investigational Medications: A subject must not have used any investigational
drug within 30 days prior to Visit 1 or within five half-lives (t½) of the prior
investigational study (whichever is the longer of the two).
8. Allergies:
• Drug Allergy: Any adverse reaction including immediate or delayed
hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal,
inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to
the constituents of the new powder inhaler (i.e., lactose).
• Milk Protein Allergy: History of severe milk protein allergy.
9. Concomitant Medication:
• Administration of prescription or over the counter medication that would
significantly affect the course of asthma, or interact with study drug.
• Immunosuppressive Medications: A subject must not be using or require use
of immunosuppressive medications during the study.
• Note: Immunotherapy for the treatment of allergies is allowed during the study
provided it was initiated 4 weeks prior to Visit 1 and subjects remain in the
maintenance phase for the duration of the study.
• Cytochrome P450 3A4 (CYP3A4) inhibitors: Subjects who have received a
potent CYP3A4 inhibitor within 4 weeks of Visit 1(e.g., ritonavir, ketoconazole,
itraconzole).
10. Compliance: A subject will not be eligible if he/she or his/her parent or legal
guardian has any infirmity, disability, disease, or 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.
11. Tobacco Use: Current smoker or a smoking history of 10 pack years (e.g., 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).
12. Affiliation with Investigator’s Site: A subject will not be eligible for this study if
he/she is an immediate family member of the participating Investigator,
sub-Investigator, study coordinator, or employee of the participating Investigator.
13. Previous Participation: A subject may not have previously been treated with fluticasone furoate or fluticasone furoate/vilanterol in a FF or FF/VI Phase II or III study (including but not limited to
FFA200001, FFA106783, FFA109684, FFA109685, FFA109687, FFA112202, HZA106827, HZA106829, HZA106837, HZA106839, HZA106851,
HZA113091).
14. Night shift workers: No subject is permitted to perform night shift work for 1 week prior to Visit 1 until completion of the study treatment period.
For further information please view pages 20-21 of the protocol.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Efficacy Endpoints:
Change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1
at the end of the 24 week treatment period. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Yes |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
|
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 27 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 1 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 1 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
Print
