Last updated: 11/02/2018 23:18:41
Influence Of Different Airflow Resistances On Drug Effect Of 50μg Salmeterol And 6 μg Formoterol
GSK study ID
101182
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Single-centre randomised open crossover study to examine the influence of different internal resistances of discus and turbohaler respectively on the effects of salmeterol and formoterol in asthmatic subjects
Trial description: Effect of inhaled drugs administered as dry powder is not only dependent on drug efficacy but also on technical properties of the inhalers. Different inhalers have different internal resistances and therefore it is expected that patients with limited airflow may have different exposure rates of drugs delivered from different devices
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: formoterol (TURBOHALER)
Drug: Salmeterol (DISKUS)
Enrollment:
77
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
salmeterol
Collaborators
Not applicable
Study date(s)
January 2004 to June 2005
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Asthma
- Reversibility >15% and 200 ml in total
- Smoking history >20 pack years
- Treatment with ICS >500μg Fluticasone or aquivalent in the last 4 weeks
Inclusion and exclusion criteria
Inclusion criteria:
- Asthma Reversibility >15% and 200 ml in total FEV1 <85% of normal
Exclusion criteria:
- Smoking history >20 pack years Treatment with ICS >500μg Fluticasone or aquivalent in the last 4 weeks Asthma exacerbation in the last 4 weeks
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-24-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website