Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02495168 · ClinicalTrials.gov registry record · Phase 3
Randomized, Placebo-Controlled, Multidose, Study Comparing Generic Budesonide/Formoterol Fumarate Dihydrate to Symbicort® in Asthmatic Participants
A Phase 3 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,714
- Enrollment target
NCT02495168: Completed Phase 3 study, sponsored by Actavis.
NCT02495168 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 1,714 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (122% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02495168, a Phase 3 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,714 participants
- Enrollment target
Study Summary
This study has a randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week open placebo Run-in Period followed by a 6-week Treatment Period with placebo, test product (budesonide 80 microgram \[μg\]/formoterol fumarate dihydrate 4.5 μg), or reference product (Symbicort® inhalation aerosol).
Primary Outcome
FEV1 was measured using spirometry in accordance with the ATS/ERS consensus guidelines. Baseline-adjusted area under the serial FEV1-time curve was calculated from Time 0 to 12 hours on the first day of the Treatment Period (Day 1). FEV1 AUC0-12 was calculated from baseline-adjusted values using the linear trapezoidal method. The calculation assumed that at time of dosing (Time 0) the baseline adjusted FEV1 was also 0. The calculation proceeded over all available post-dose FEV1 assessments on Da
Interventions
- DRUG Placebo
- DRUG Generic Budesonide/Formoterol Fumarate Dihydrate
- DRUG Symbicort® (Budesonide/Formoterol Fumarate Dihydrate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,714 participants |
| Start Date | 2017-01-13 |
| Est. Completion | 2018-05-31 |
| Phase | Phase 3 |
What the finished NCT02495168 record still lists
NCT02495168 is an interventional study that assigns participants to a tested intervention. Its 1,714 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (122% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02495168 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02495168 about?
NCT02495168 is a clinical study titled "Randomized, Placebo-Controlled, Multidose, Study Comparing Generic Budesonide/Formoterol Fumarate Dihydrate to Symbicort® in Asthmatic Participants". This study has a randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week open placebo Run-in Period followed by a 6-week Treatment Period with placebo, test product (budesonide 80 microgram \[μg\]/formoterol fumarate dihydrate 4.5 μg), or reference product (Symbico...
What is the current status of trial NCT02495168?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,714 participants. The study started on 2017-01-13. Estimated completion is 2018-05-31.
What interventions are being tested in trial NCT02495168?
The interventions under investigation include: Placebo (DRUG), Generic Budesonide/Formoterol Fumarate Dihydrate (DRUG), Symbicort® (Budesonide/Formoterol Fumarate Dihydrate) (DRUG).
Who is sponsoring clinical trial NCT02495168?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02495168's enrollment target sits among peer trials
1,714 130th of 2000 higher than 1,870 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04291612 · 1,715 participants
Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease
- NCT05303636 · 1,710 participants · Phase 4
LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women
- NCT07304531 · 1,705 participants
First To Know Pregnancy Test - Clinical Evaluation Protocol
- NCT06898034 · 1,725 participants
Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI