A Single-dose, Randomised, Crossover, Placebo-controlled Study Assessing Two Fixed-dose Combinations of Inhaled Long-acting Beta-agonist and Corticosteroid

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)

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Salmeterol/fluticasone propionate; Drug: LAS40468

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • Almirall Investigational Site #1
• United Kingdom
  • Harrow, United Kingdom, HA1 3UJ
    • Almirall Investigational Site #2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LAS40468; Single dose, administered via Genuair® dry powder inhaler (DPI)	Drug: LAS40468
Active Comparator: Salmeterol/fluticasone propionate; Single dose, Seretide® (salmeterol fluticasone propionate) administered via Accuhaler™	Drug: Salmeterol/fluticasone propionate; Other Names: Seretide®
Placebo Comparator: Placebo; Single dose administered via Genuair® or Accuhaler™ dry powder inhaler (DPI)	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	An adverse event (AE) is any untoward medical occurrence in a clinical trial subject (regardless of the administration of the IMP and the causal relationship to it). An AE can therefore be any unfavourable and unintended medical occurrence during subject's participation in the trial, including deterioration of a pre-existing medical, an ECG abnormality, a blood pressure abnormal value or an abnormal finding in the physical examination. A Serious AE is any AE that: results in death, is life-threatening, requires hospitalisation or prolongs existing hospitalisation, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is any other medically important event that may jeopardise the subject or may require intervention to prevent one of the other above outcomes. Any suspected transmission via a medicinal product of an infectious agent is also considered a serious AE.	7-9 weeks

Collaborators and Investigators

• Sponsor: Almirall, S.A.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (Estimate): March 21, 2014

Study Record Updates

• Last Update Posted (Estimate): May 22, 2014
• Last Update Submitted That Met QC Criteria: May 21, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Fluticasone; Xhance; Salmeterol Xinafoate
• Other Study ID Numbers: M-40468-10; 2013-002939-25 (EudraCT Number)