EUCTR2013-005365-39-GB
Active, Not Recruiting
Phase 1
A guideline approach to therapy step-down utilising Flutiform®: change and step-down (FFLU-X study) - Flutiform® Change and Step-Down Study (FFLU-X study) v.1.0
Research in Real-Life Ltd0 sites224 target enrollmentFebruary 5, 2014
ConditionsAsthmaMedDRA version: 16.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 16.1Level: PTClassification code 10038683Term: Respiratory disorderSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- Research in Real-Life Ltd
- Enrollment
- 224
- Status
- Active, Not Recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •To be included in phase 1 of the study, all of the criteria below need to be met:
- •1\) Able and willing to provide written informed consent and to comply with the study protocol
- •2\) Current diagnosis of asthma (as evidenced by appropriate diagnostic code)
- •3\) Step 4 of the BTS guidelines
- •4\) Received at least 4 inhalers of Seretide® 250 Evohaler® 2 puffs twice daily in the last 6 months (corresponds to \=66% compliance)
- •5\) No asthma exacerbation\* in last 3 months
- •6\) \=2 exacerbations\* in last 12 months
- •7\) No critical errors in device use after training (during baseline visit)
- •8\) Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after discontinuation of study drug. Acceptable methods of contraception include intrauterine device (IUD) known to have a failure rate of less than 1% per year, steroidal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, abstinence, and partner vasectomy.
- •\* Exacerbation defined as acute course of oral steroids, emergency room attendance and/or hospitalisation for asthma
Exclusion Criteria
- •1\) Chronic respiratory disease other than asthma
- •2\) Uncontrolled asthma (according to the Global Initiative for Asthma (GINA) criteria)
- •3\) Participation in a clinical study within the past year
- •4\) Hypersensitivity to Flutiform®, its component Formoterol or its excipients
- •5\) Pregnancy
Outcomes
Primary Outcomes
Not specified
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