Clinical trial NCT02094274: A Single-dose, Randomised, Crossover, Placebo-controlled Study Assessing Two Fixed-dose Combinations of Inhaled Long-acting Beta-agonist and Corticosteroid
Official title: A Single-dose, Randomised, Crossover, Placebo-controlled, Double-dummy, Pharmacodynamic Clinical Trial Assessing Two Fixed Dose Combinations of Long-acting Beta-agonist (LABA) and Inhaled Corticosteroid (ICS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2014-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the the ability of a single dose of LAS40468 administered via Genuair® and a single dose of salmeterol/fluticasone propionate (Seretide®) administered via Accuhaler to produce bronchodilation (opening of the airways) and the safety and tolerability of the treatments

Detailed description: This is a Phase 1, randomised, double-blind, double-dummy, cross-over trial to assess the bronchodilation effect of a single dose of LAS40468 and a single dose of salmeterol/fluticasone propionate (Seretide®) administered to adult patients with stable asthma.

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.

Eligibility criteria: Inclusion Criteria:

* Adult males and non-pregnant, non-lactating females aged between 18 and 60 years (both inclusive)
* 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 clinically significant respiratory or pulmonary diseases other than asthma or history of thoracic surgery
* Patients with a Body Mass Index (BMI) \< 18 or \> 40kg/m2 (both inclusive)

Primary outcomes:
measure: Change from baseline (pre-dose at each period) in normalised forced expiratory volume in 1 second (FEV1) area under the curve (AUC) over the 12 hour period after IMP administration (AUC0-12)
timeFrame: 12 Hours
Secondary outcomes:
measure: Adverse events
timeFrame: 7-9 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Almirall Investigational Site #1
city: Harrow
country: United Kingdom
facility: Almirall Investigational Site #2
Study officials:
References: