A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Multicentre Study to assess efficacy and safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and Fluticasone Propionate FP)/Salmeterol Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents.
- Conditions
- Persistent Asthma in Adults and Adolescents.MedDRA version: 12.1Level: LLTClassification code 10003553Term: Asthma
- Registration Number
- EUCTR2010-019589-10-NL
- Lead Sponsor
- GlaxoSmithKline Research & Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1564
1. Informed consent: Subjects must give their signed and dated written informed
consent to participate
2. Type of Subject: Outsubjects 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) 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.
To be eligible for entry into the study, females of childbearing potential must commit
to consistent and correct use of an acceptable method of birth control, 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 oestrogen/progestin or progestin only)
• Any intrauterine device (IUD) with a documented failure rate of less than 1%
per year
• Double barrier method–spermacide plus a mechanical barrier (e.g.,
spermacide plus a male condom or a spermacide and female diaphragm).
• Oestrogenic vaginal ring
• Percutaneous contraceptive patches
• Females of childbearing potential who are not sexually active must commit to
complete abstinence from intercourse throughout the clinical study and for a
period after the study 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 6 or early withdrawal. In addition, a urine pregnancy test will
be performed on all females of childbearing potential at Visit 2
(Randomisation). Subjects will be given a home urine pregnancy kit for use
during the follow-up period.
4. Severity of Disease: A best evening pre-bronchodilator FEV1 of =40%- and =85%
of the predicted normal value. Predicted values will be based upon NHANES III
[Hankinson, 1999]. 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 [Hankinson, 2010]. Otherwise, the
Caucasian equations will be used.
5. Reversibility of Disease: Demonstrated a =12% and =200ml reversibility of FEV1
within 10-40-minutes following 2-4 inhalations of salbutamol/albuterol inhalation
aerosol or equivalent dose of nebulised salbutamol/albuterol at the Screening Visit.
6. Current Anti-Asthma Therapy: Subjects must have been using an inhaled
corticosteroid for at least 12 weeks prior to Visit 1 and be maintained on a medium
dose (e.g. FP 250 mcg twice daily) for at least 4 weeks prior to Visit 1view protocol for further information.
7. Short-Acting Beta2-Agonists: All subjects must be able to replace their current
short-acting beta2-agonists with salbutamol/albuterol inhaler at Visit 1 for use as
needed for the duration of the study. Subjects must be able to withhold
salbutamol/albuterol for at least 6 hours prior to lung function assessments.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Numbe
1. History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures within the last 5 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 prior to 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 hospitalisation requiring additional treatment for asthma within 12 weeks 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 subjects 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 view page 18 of the protocol for futher 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 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 novel dry powder inhaler or
ACCUHALER™/DISKUS™ (i.e., lactose or magnesium stearate).
• 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, such as: anticonvulsants (barbiturates, hydantoins, carbamazepine); polycyclic antidepressants; beta-adrenergic blocking agents; phenothiazines and monoamine oxidase (MAO) inhibitors.
• 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.
11. Tobacco Use: Current smoker or with a sm
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method