Study of FlutiForm® Versus Fluticasone Plus Formoterol in Adult Subjects With Severe Asthma
Information source: Mundipharma Research Limited
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma, Bronchial
Intervention: Flutiform 250/10 micrograms (Drug); Flutiform 50/5 micrograms (Drug); Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms (Drug); Flixotide pMDI 250 micrograms (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Mundipharma Research Limited
Summary
The study compares the efficacy and safety of FlutiForm® vs Flixotide® plus Foradil® in the
treatment of severe persisent asthma in adult subjects.
Clinical Details
Official title: A Double Blind, Double Dummy, Randomised, Multicentre, Four Arm Parallel Group Study to Assess the Efficacy and Safety of FlutiForm® pMDI 250/10µg (2 Puffs Bid) vs Fluticasone pMDI 250µg (2 Puffs Bid) Plus Formoterol pMDI 12µg (2 Puffs Bid) Administered Concurrently in Adult Subjects With Severe Persistent, Reversible Asthma.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Comparison of FEV1 (Forced expiratory volume in the first second) values.
Secondary outcome: Other lung function parameters, asthma symptom scores, sleep disturbance due to asthma, rescue medication use, AQLQ, safety assessments.
Detailed description:
This is a study involving a 2 week run-in phase followed by an 8 week double blind treatment
phase. During the run-in phase, subjects receive Flixotide®. In the treatment phase subjects
will be randomised to one of the four treatment groups and will receive either high dose
FlutiForm® and Foradil® plus Flixotide® placebo or low dose FlutiForm® plus Foradil® and
Flixotide® placebo or Foradil® plus Flixotide® and FlutiForm® placebo or Flixotide® and
FlutiForm® plus Foradil® placebo. Efficacy will be assessed by lung function tests, asthma
symptoms, sleep disturbance due to asthma and rescue medication use. Safety will be assessed
by adverse events, lab tests, ECGs and vital signs.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion criteria:
1. Male or female subjects at least 18 years old.
2. Females less than one year post-menopausal must have a negative urine pregnancy test
recorded at the screening visit prior to the first dose of study medication, be
non-lactating, and willing to use adequate and highly effective methods of
contraception throughout the study. A highly effective method of birth control is
defined as those which result in a low failure rate (i. e., less than 1% per year)
when used consistently and correctly such as sterilisation, implants, injectables,
combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual
abstinence or vasectomised partner.
3. Known history of severe persistent, reversible asthma for ≥ 6 months prior to the
Screening Visit characterised by treatment with ICS at a dose of ≥ 500µg fluticasone
or equivalent.
4. Demonstrated a FEV1 of ≥ 40% to ≤ 80% for predicted normal values (Quanjer et al.,
1993) during the Screening Visit (Visit 1) and Randomisation Visit (Visit 3)
following appropriate withholding of asthma medications (if applicable).
- No β2-agonist use on day of screening.
- No use of inhaled combination asthma therapy on day of screening.
- Inhaled corticosteroids are allowed on day of screening.
5. Documented reversibility of ≥ 15% in FEV1 in the screening phase.
6. Demonstrated satisfactory technique in the use of the study medication.
7. Willing and able to enter information in the electronic diary and attend all study
visits.
8. Willing and able to substitute study medication for their pre study prescribed asthma
medication for the duration of the study.
9. Written informed consent obtained.
Inclusion criteria required following run-in:
10. Subject has used rescue medication for at least 3 days AND had at least one night
with sleep disturbance (i. e., sleep disturbance score of ≥ 1) OR at least 3 days with
asthma symptoms (i. e., a symptom score of ≥ 1) during the last 7 days of the run-in
period.
Exclusion criteria:
1. Near fatal or life-threatening (including intubation) asthma within the past year.
2. Hospitalisation or an emergency visit for asthma within the 4 weeks before the
screening visit.
3. Known history of systemic (injectable or oral) corticosteroid medication within 1
month of the Screening Visit.
4. Known history of omalizumab use within the past 6 months.
5. Current evidence or known history of any clinically significant disease or
abnormality including uncontrolled coronary artery disease, congestive heart failure,
myocardial infarction, or cardiac dysrhythmia. 'Clinically significant' is defined as
any disease that, in the opinion of the Investigator, would put the subject at risk
through study participation, or which would affect the outcome of the study.
6. In the investigator's opinion a clinically significant upper or lower respiratory
infection within 4 weeks prior to the Screening Visit.
7. Significant, non-reversible, active pulmonary disease (e. g., chronic obstructive
pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis).
8. Known Human Immunodeficiency Virus (HIV)-positive status.
9. Subject has a smoking history equivalent to "10 pack years" (i. e., at least 1 pack of
20 cigarettes /day for 10 years or 10 packs/day for 1 year, etc.).
10. Current smoking history within 12 months prior to the Screening Visit.
11. Current evidence or known history of alcohol and/or substance abuse within 12 months
prior to the Screening Visit.
12. Subject has taken B-blocking agents, tricyclic antidepressants, monoamine oxidase
inhibitors, astemizole (Hismanal), quinidine type antiarrhythmics, or potent CYP 3A4
inhibitors such as ketoconazole within the past week.
13. Current use of medications other than those allowed in the protocol that will have an
effect on bronchospasm and/or pulmonary function.
14. Current evidence or known history of hypersensitivity or idiosyncratic reaction to
test medications or components.
15. Subject has recieved an investigational drug within 30 days of the Screening Visit
(12 weeks if an oral or injectable steroid).
16. Subject is currently participating in a clinical study.
Locations and Contacts
Siofok, Hungary
Additional Information
Results available on website
Starting date: September 2008
Last updated: August 9, 2012
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