Last updated: 11/07/2018 18:53:29
A Four-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multi-Center Study of Ventolin HFA MDI delivered TID with facemask and valved holding chamber (Aerochamber Plus) in subjects birth to <24 months in age with symptoms of bronchospasm (i.e. wheeze, cough, dyspnea or chest tightness) consistent with obstructive airways disease.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Four-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multi-Center Study of Ventolin HFA MDI delivered TID with facemask and valved holding chamber (Aerochamber Plus) in subjects birth to <24 months in age with symptoms of bronchospasm (i.e. wheeze, cough, dyspnea or chest tightness) consistent with obstructive airways disease.
Trial description: A Four-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multi-Center Study of Ventolin HFA MDI delivered TID with facemask and valved holding chamber (Aerochamber Plus) in subjects birth to <24 months in age with symptoms of bronchospasm (i.e. wheeze, cough, dyspnea or chest tightness) consistent with obstructive airways disease.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Angela Davis, William Lincourt, Roopa Trivedi, et.al. Safety of Ventolin HFA MDI in Children Birth-<24 Months Old with Symptoms of Bronchospasm Presented at the Annual Meeting of American Academy of Allergy, Asthma and Immunology March 3-7, 2006 Miami Beach, FL
Medical condition
Asthma
Product
salbutamol
Collaborators
Not applicable
Study date(s)
July 2004 to February 2005
Type
Not applicable
Phase
2/3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-15-02
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
Not applicable
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