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NCT01641692 · ClinicalTrials.gov registry record · Phase 2
A 3-period Crossover Study With GSK573719 as Monotherapy in Adult Subjects With Asthma
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 350
- Enrollment target
NCT01641692 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 350 participants.
The verdict
NCT01641692, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 350 participants
- Enrollment target
Study Summary
This is a multi-national, randomized, double-blind, 3-period crossover, incomplete block design to evaluate 5 once-daily and 2 twice-daily doses of GSK573719 in combination with placebo. The study will explore the dose range of GSK573719 in asthmatic subjects who are currently using non-ICS controller medications. Subjects will participate in the study for up to a maximum of 14 weeks. At randomization subjects will be stratified by age to ensure adequate exposure to GSK573719 throughout the expected age range. The primary endpoint will be trough FEV1 obtained 24 hours after the last morning dose on Day 14 of each treatment sequence. A sub-group of subjects at selected sites (approximately 30% of the total population) will have additional serial assessments for spirometry, ECG and Holter, and pharmacokinetic sampling at the start and end of each treatment period. Safety assessments will include monitoring for adverse events, laboratory tests, asthma symptom assessments and twice daily PEF evaluation. Consenting subjects will have a blood sample taken for pharmacogenetic analysis.
Interventions
- DRUG GSK573719 Active treatment or Placebo
- PROCEDURE GSK573719 (Sub-group cohort)
- DRUG Salbutamol/Albuterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2012-05 |
| Est. Completion | 2013-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01641692
The ClinicalTrials.gov registry entry for NCT01641692 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which GSK573719 Active treatment or Placebo is the first listed.
NCT01641692 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01641692 about?
NCT01641692 is a clinical study titled "A 3-period Crossover Study With GSK573719 as Monotherapy in Adult Subjects With Asthma". This is a multi-national, randomized, double-blind, 3-period crossover, incomplete block design to evaluate 5 once-daily and 2 twice-daily doses of GSK573719 in combination with placebo. The study will explore the dose range of GSK573719 in asthmatic subjects who are currently using non-ICS controll...
What is the current status of trial NCT01641692?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 350 participants. The study started on 2012-05. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01641692?
The interventions under investigation include: GSK573719 Active treatment or Placebo (DRUG), GSK573719 (Sub-group cohort) (PROCEDURE), Salbutamol/Albuterol (DRUG).
Who is sponsoring clinical trial NCT01641692?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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