Last updated: 11/04/2018 05:40:48
A Multiple Use Tolerability study of a Breathe Right Nasal Strip Prototype
GSK study ID
B3560692
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Multiple Use Tolerability study of a Breathe Right Nasal Strip Prototype
Trial description: This study evaluated the safety & tolerability of two Breathe Right nasal strip prototypes. Prototypes were produced as an improvement to the currently marketed product.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Dermal response score of the application site of the nasal strip
Timeframe: Baseline through 7 days
Secondary outcomes:
Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip
Timeframe: 7 days
Interventions:
Device: Marketed Nasal Strip
Device: Prototype Nasal Dilator
Enrollment:
80
Observational study model:
Not applicable
Primary completion date:
2009-30-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects
Product
Breathe Right
Collaborators
Not applicable
Study date(s)
November 2009 to November 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Inclusion Criteria:
- Healthy subjects
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria:
- Healthy subjects
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
2009-30-11
Actual study completion date
2009-30-11
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
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