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Clinical Trials/EUCTR2011-001644-29-SK
EUCTR2011-001644-29-SK
Active, not recruiting
Not Applicable

SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects with Asthma. - AUSTRI

GlaxoSmithKline Research & Development Limited0 sites11,664 target enrollmentStarted: April 12, 2012Last updated:
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DrugsFlixotide Accuhaler 100 microgramsSeretide 100 AccuhalerFlixotide Accuhaler 250 microgramsSeretide 250 AccuhalerFlixotide Accuhaler 500 microgramsSeretide 500 Accuhaler

Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
11,664
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •French subjects: In France, a subject will be eligible for inclusion in this study only if
  • •either affiliated to or a beneficiary of a social security category.
  • •1\. Informed Consent:
  • •The subject and/or the subject’s legal guardian (if applicable) must provide
  • •written informed assent/consent to take part in the study.
  • •Subjects and/or their legal guardians (if applicable) understand that they must
  • •comply with study treatment and study assessments including recording of daily
  • •information regarding their asthma status and attend scheduled study visits, and
  • •be accessible by telephone.
  • •2\. Subject: 12 years of age and older.

Exclusion Criteria

  • •1\. History of Life\-Threatening Asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non\-invasive ventilatory support.
  • •2\. Concurrent Respiratory Disease: Subjects with current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other respiratory abnormalities other than asthma.
  • •3\. Chronic Obstructive Pulmonary Disease: chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.
  • •4\. Tobacco Use.
  • •5\. Exercise\-induced Asthma: Subjects with exercise induced asthma (as the only asthma\-related diagnosis) not requiring daily asthma control medicine.
  • •6\. Respiratory Infection: Culture\-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved at randomization.
  • •7\. Unstable Asthma Status: Subjects must not meet the following unstable asthma severity criteria within 7\-days prior to randomization:
  • •Asthma symptoms that persisted throughout the day on 2 consecutive days
  • •Nighttime awakening due to asthma \=3 times
  • •Albuterol/salbutamol (or equivalent) use for the acute worsening of asthma

Investigators

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A 6-month study to assess the safety and benefit of inhaled fluticasone propionate/salmeterol combination compared with inhaled fluticasone propionate in the treatment of adolescents (12 years and over) and adults with asthma.AsthmaMedDRA version: 18.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
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EUCTR2011-001644-29-ITGLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.11,664