Efficacy and Safety of Flutiform® pMDI in Adult Patients With Mild to Moderate-severe Reversible … (NCT00476073) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Flutiform® pMDI in Adult Patients With Mild to Moderate-severe Reversible Asthma
United Kingdom228 participantsStarted 2007-04
Plain-language summary
Open, parallel group design. The study has a screening phase and a 12 week treatment phase. Subjects will be randomised to treatment in a 1:1 ration.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female patients at least 18 years or older (females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded within 72 hours 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 sterilization, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner).
* Known history of mild to moderate-severe reversible asthma for \> 6 months prior to the screening visit.
* Demonstrate a FEV1 of \>40% to \<80% for predicted normal values (EGKS normal values, 1983) during the screening phase following appropriate withholding of asthma medications (if applicable).
* No beta agonist use on day of screening.
* No use of combination asthma therapy on day of screening.
* Inhaled corticosteroids are allowed on day of screening.
* Documented reversibility of \> 15% in FEV1 in the screening phase.
* Demonstrate satisfactory technique in the use of the pressurized MDI.
* Willing and able to enter information in the electronic diary and attend all study visits.
* Willing and able to substitute study medication for their pre study prescribed asthma medication for the duration …
What they're measuring
1
FEV1, (Forced expiratory volume in the 1st second).