Phase 2
N=147
Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02105012 ↗Enrolled (actual)
147
Serious AEs
0.4%
Results posted
Jun 2017
Primary outcome: Primary: Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period — -0.002; -0.001; -0.034; -0.031 Liters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BD MDI 320 µg (Drug); BD MDI 160 µg (Drug); BD MDI 80 µg (Drug); BD MDI 40 µg (Drug); Placebo MDI (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pearl Therapeutics, Inc.
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period |
-0.002; -0.001; -0.034; -0.031; -0.116 | — |
| SECONDARY Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR) |
-5.802; -7.461; -9.992; -5.653; -29.933 | — |
| SECONDARY Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR) |
-7.345; -11.791; -14.403; -1.896; -32.807 | — |
| SECONDARY Change From Baseline in Mean Number of Puffs of Rescue Ventolin HFA |
-0.140; -0.268; -0.312; -0.095; 0.606 | — |
| SECONDARY Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score |
-0.575; -0.565; -0.515; -0.407; -0.100 | — |
Summary
Study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent asthma.
Eligibility Criteria
Inclusion Criteria
- ≥ 18 - 65 years of age
- Diagnosis of mild to moderate persistent asthma, diagnosed at least 6 months prior to screening
- Currently receiving treatment with a low to medium dose of an inhaled corticosteroid (ICS) OR a combination of controller medications for at least 4 weeks preceding screening
- Pre-albuterol FEV1 of > 60% and 10 pack year history of cigarettes, cigars, or pipe smoking
- Respiratory tract infection within 6 weeks prior to Visit 1
- Subjects with documented myocardial infarction within a year from screening visit
- Clinically significant abnormal ECG
- Abnormal liver function tests defined as aspartate aminotransferase (AST), alanine aminotransferace (ALT), alkaline phosphatase or total bilirubin ≥ 1.5 times upper limit of normal on repeat testing
- Subjects who have cancer that has not been in complete remission for at least 5 years
- Drug Allergy: Subjects who have a history of hypersensitivity to any component of the metered-dose inhaler (MDI)
Data sourced from ClinicalTrials.gov (NCT02105012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.