MedTrace Logo

Inhalation of Corticosteroids in Smoking and Non-smoking Asthmatics.

NCT01400906 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-08-13

Study results available
· View outcomes & findings →

Summary

People with asthma suffer from breathlessness because the small tubes (bronchioles) that carry air in and out of the lungs become inflamed and narrow. Steroids reduce the inflammation, and are commonly used to control asthma, but they do not work well in some asthmatics, particularly those who smoke.

This study is done to find out more about why smokers with asthma do not benefit from steroid treatment. In this study, the effect of Flixotide (fluticasone propionate), a steroid widely used to treat asthma, is tested in smokers and non-smokers with mild asthma.

16 smokers and 16 non-smokers, aged 18-55 years will be enrolled in this study.

Subjects will take each of the following treatments:

* 100 micrograms Flixotide twice daily for 7 days;
* 500 micrograms Flixotide twice daily for 7 days; and
* placebo (dummy medicine) twice daily for 7 days.

Study design: subjects will have a screening visit (over 2 days), and will take part in 3 treatment periods (which are separated by interval of at least 14 days); a follow-up visit is scheduled 7 days after the last intake of study treatment.

The order in which order the subjects will take the treatments is defined at random. Total study duration: about 11 weeks.

To test the effects of Flixotide, the subject's responses to :

* an inhaled allergen test
* a PC20 methacholine test
* blood, urine and sputum PD markers will be analysed.

This study will take place in 2 centres: 1 in the United Kingdom and 1 in Belgium. The units will recruit participants by advertising (newspaper, radio, and websites), word of mouth, from volunteer databases, and via the centres' websites.

Conditions

Interventions

DRUG

100 micrograms Fluticasone propionate

100 micrograms micronized drug blended with lactose in dry powder inhalator

DRUG

500 micrograms Fluticasone propionate

500 micrograms micronized drug blended with lactose in dry powder inhalator

DRUG

lactose powder

lactose powder in dry powder device : placebo comparator

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-20
Primary Completion
2012-12-01
Completion
2012-12-12

Countries

  • Belgium
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01400906 on ClinicalTrials.gov