A Single-dose, Randomised, Crossover, Placebo-controlled Study Assessing Two Fixed-dose Combinations of Inhaled Long-acting Beta-agonist and Corticosteroid
NCT ID: NCT02094274
Last Updated: 2014-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2013-11-30
2014-05-31
Brief Summary
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Detailed Description
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The study will consist of a screening visit and treatment periods of approximately 13 hours separated by washout periods of 7 to 14 days from the time of Investigational Medicinal product (IMP) administration.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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LAS40468
Single dose, administered via Genuair® dry powder inhaler (DPI)
LAS40468
Salmeterol/fluticasone propionate
Single dose, Seretide® (salmeterol fluticasone propionate) administered via Accuhaler™
Salmeterol/fluticasone propionate
Placebo
Single dose administered via Genuair® or Accuhaler™ dry powder inhaler (DPI)
Placebo
Interventions
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LAS40468
Salmeterol/fluticasone propionate
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with a confirmed 6-months' history of asthma at the time of enrolment into the trial
* Patients treated with short-acting beta-agonists or inhaled corticosteroids at a stable dose and regimen (up to the equivalent of 1600 μg/day of beclometasone dipropionate) for at least 4 weeks prior to screening
* Patients whose (pre-salbutamol) forced expiratory volume in 1 second (FEV1) at screening is \>60% of the predicted normal value after a washout of at least 6 hours for short-acting beta-agonists and 48 hours for long-acting beta-agonists, if applicable
* Patients with a FEV1 absolute increase of at least 250 mL over baseline value after inhalation of 4 puffs of 100 μg of salbutamol in one of two pulmonary function tests performed within 10-15 min
Exclusion Criteria
* Patients with a Body Mass Index (BMI) \< 18 or \> 40kg/m2 (both inclusive)
18 Years
60 Years
ALL
No
Sponsors
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Almirall, S.A.
INDUSTRY
Responsible Party
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Locations
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Almirall Investigational Site #1
Berlin, , Germany
Almirall Investigational Site #2
Harrow, , United Kingdom
Countries
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Other Identifiers
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2013-002939-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M-40468-10
Identifier Type: -
Identifier Source: org_study_id
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