At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 208 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Placebo 0 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 3-month Safety Evaluation Extension to the 12-week E004-C Study in Asthma Patients (A Double Blinded, Placebo-controlled, Parallel, 3-month Safety Study in Adolescent and Adult Patients With Asthma)
In Brief
A Phase 3 clinical trial evaluating Placebo, Primatene Mist, and 1 other intervention for Asthma. Completed, enrolled 208 participants across 27 sites.
Detailed Summary
E004-C2 is a continuation of E004-C for safety evaluations with additional 3 months to be able to assess the 6-month safety profile for E004 (epinephrine inhalation) versus placebo in a double-blinded manner.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
First PostedNov 2011
Primary CompletionApr 2012
Study CompletionJul 2012
TodayJul 2026
First PostedNov 22, 2011
Enrollment StartNov 1, 2011
Primary CompletionApr 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.6 years ago
Interventions
Placebodrug
0 mcg/inhalation, 2 inhalations QID
Primatene Mistdrug
220 mcg/inhalation, 2 inhalations QID
Epinephrine inhalationdrug
125 mcg/inhalation, 2 inhalations QID