A Single-dose, Randomised, Crossover, Placebo-controlled Study Assessing Two Fixed-dose Combinations of Inhaled Long-acting Beta-agonist and Corticosteroid
2 other identifiers
interventional
30
2 countries
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 asthma
Started Nov 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 20, 2014
CompletedFirst Posted
Study publicly available on registry
March 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMay 22, 2014
March 1, 2014
6 months
March 20, 2014
May 21, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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)
12 Hours
Secondary Outcomes (1)
Adverse events
7-9 weeks
Study Arms (3)
LAS40468
EXPERIMENTALSingle dose, administered via Genuair® dry powder inhaler (DPI)
Salmeterol/fluticasone propionate
ACTIVE COMPARATORSingle dose, Seretide® (salmeterol fluticasone propionate) administered via Accuhaler™
Placebo
PLACEBO COMPARATORSingle dose administered via Genuair® or Accuhaler™ dry powder inhaler (DPI)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Almirall, S.A.lead
Study Sites (2)
Almirall Investigational Site #1
Berlin, 14050, Germany
Almirall Investigational Site #2
Harrow, HA1 3UJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2014
First Posted
March 21, 2014
Study Start
November 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
May 22, 2014
Record last verified: 2014-03