AsthmaPhase 2NCT02105012
Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma
A Phase 2 study testing BD MDI 320 µg, BD MDI 160 µg and BD MDI 80 µg in people with Asthma, run by Pearl Therapeutics, Inc. at 41 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- BD MDI 320 µg, BD MDI 160 µg and BD MDI 80 µg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 41 sitesUnited States
- Study dates
- 1 Apr 2014to 4 Sep 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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 < 85% of predicted normal value
- Reversibility: Increase in FEV1 of ≥ 12% and ≥ 200 mL over the pre-albuterol FEV1 within 30 - 60 minutes after the inhalation of 4 puffs of Ventolin hydrofluoroalkane (HFA)
- Asthma Symptom Criteria: Have required albuterol use on at least two of the last seven days and have an Asthma Control Questionnaire (ACQ) total score ≥ 1.5 prior to Randomization
Who cannot join
- Life-Threatening Asthma: A subject must not have life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within the 12 months prior to screening
- Worsening of Asthma: A subject must not have experienced a worsening of asthma which involved an emergency department visit, hospitalization or use of oral/parenteral corticosteroids within 6 weeks of screening
- Intermittent, Seasonal, or Exercise-Induced Asthma Alone: Subjects with only intermittent, seasonal or exercise-induced asthma are excluded from participation in this study
- Concurrent Respiratory Disease
- Pregnant women or nursing mothers
- A current diagnosis of Chronic Obstructive Pulmonary Disease (COPD
Show all 13Show fewer
- Current smokers or subjects with a > 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)
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Pearl Therapeutics Study Site
Athens, Alabama
Pearl Therapeutics Study Site
Birmingham, Alabama
Pearl Therapeutics Study Site
Blue Island, Illinois
Pearl Therapeutics Study Site
Charlotte, North Carolina
Pearl Therapeutics Study Site
Cincinnati, Ohio
Pearl Therapeutics Study Site
Clearwater, Florida
Pearl Therapeutics Study Site
Clermont, Florida
Pearl Therapeutics Study Site
Columbus, Ohio
Pearl Therapeutics Study Site
Dayton, Ohio
Pearl Therapeutics Study Site
El Paso, Texas
Pearl Therapeutics Study Site
Everett, Washington
Pearl Therapeutics Study Site
Foley, Alabama
Pearl Therapeutics Study Site
Greenville, South Carolina
Pearl Therapeutics Study Site
Hazelwood, Missouri
Pearl Therapeutics Study Site
Houston, Texas
Pearl Therapeutics Study Site
Lake Oswego, Oregon
Pearl Therapeutics Study Site
Los Angeles, California
Pearl Therapeutics
Los Angeles, California
Pearl Therapeutics Study Site
Medford, Oregon
Pearl Therapeutics Study Site
Miami, Florida
Pearl Therapeutics Study Site
Middleburg Heights, Ohio
Pearl Therapeutics Study Site
North Dartmouth, Massachusetts
Pearl Therapeutics Study Site
Oklahoma City, Oklahoma
Pearl Therapeutics Study Site
Oregon, Ohio
Pearl Therapeutics Study Site
Orlando, Florida
Pearl Therapeutics Study Site
Ormond Beach, Florida
Pearl Therapeutics Study Site
Plano, Texas
Pearl Therapeutics Study Site
Rapid City, South Dakota
Pearl Therapeutics Study Site
Rolling Hills Estates, California
Pearl Therapeutics Study Site
Saint Cloud, Florida
Pearl Therapeutics Study Site
San Antonio, Texas
Pearl Therapeutics Study Site
San Diego, California
Pearl Therapeutics Study Site
Sebring, Florida
Pearl Therapeutics Study Site
Skillman, New Jersey
Pearl Therapeutics Study Site
Spartanburg, South Carolina
Pearl Therapeutics Study Site
Stockton, California
Pearl Therapeutics Study Site
Sylvania, Ohio
Pearl Therapeutics Study Site
Tampa, Florida
Pearl Therapeutics Study Site
Toledo, Ohio
Pearl Therapeutics Study Site
Tullahoma, Tennessee
Pearl Therapeutics Study Site
Winston-Salem, North Carolina
About this study
Official title: Randomized, Double-Blind, Chronic Dosing (4 Weeks), Four-Period, Five-Treatment, Incomplete Block, Cross-Over, Multi-Center 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
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.
Read the detailed description
This is a randomized, double-blind, chronic dosing (4 weeks), four-period, five-treatment, incomplete block, cross-over, multicenter 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.
- Conditions
- Asthma
- Being tested
- BD MDI 320 µg, BD MDI 160 µg, BD MDI 80 µg, BD MDI 40 µg, Placebo MDI
- Keywords
- Mild, moderate persistent, Adult
- Medical subject headings
- Asthma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD MDI 320 µgDrug
Also called PT008
Budesonide Inhalation Aerosol administered as 2 inhalations BID
BD MDI 160 µgDrug
Also called PT008
Budesonide Inhalation Aerosol administered as 2 inhalations BID
BD MDI 80 µgDrug
Also called PT008
Budesonide Inhalation Aerosol administered as 2 inhalations BID
BD MDI 40 µgDrug
Also called PT008
Budesonide Inhalation Aerosol administered as 2 inhalations BID
Placebo MDIDrug
Placebo MDI administered as 2 inhalations BID
| Study group | Role | What they receive |
|---|---|---|
| BD MDI 320 µg | Experimental | Budesonide metered dose inhaler (BD MDI) 320 µg (PT008) administered as 2 inhalations BID Receives: Drug: BD MDI 320 µg |
| BD MDI 160 µg | Experimental | BD MDI 160 µg (PT008) administered as 2 inhalations BID Receives: Drug: BD MDI 160 µg |
| BD MDI 80 µg | Experimental | BD MDI 80 µg (PT008) administered as 2 inhalations BID Receives: Drug: BD MDI 80 µg |
| BD MDI 40 µg | Experimental | BD MDI 40 µg (PT008) administered as 2 inhalations BID Receives: Drug: BD MDI 40 µg |
| Placebo MDI | Placebo comparator | Placebo MDI administered as 2 inhalations BID Receives: Drug: Placebo MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period
Change from baseline in morning pre-dose trough Forced Expiratory Volume in 1 second (FEV1) at the end of the Treatment Period.
Measured: Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)
Secondary outcomes (4)
Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
Measured: Baseline to Last 7 Days of Treatment Period
Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
Measured: Baseline to Last 7 Days of Treatment Period
Change From Baseline in Mean Number of Puffs of Rescue Ventolin HFA
Change from baseline in mean number of puffs of rescue Ventolin HFA
Measured: Baseline to Last 7 Days of Treatment
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score
The ACQ-5 measures 5 symptoms (woken at night by symptoms, wake in the morning with symptoms, limitation of daily activities, shortness of breath, and wheeze). The scale is 0-6, where 0=minimum and 6=maximum
Measured: Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study start1 Apr 2014
- Primary completion1 Sep 2015
- Study completion4 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Dorinsky, MD, FCCP, Study director, Pearl Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105012
- Sponsor's protocol ID
- PT008001
- Status last verified
- May 2017
- First submitted
- 2 Apr 2014
- Last updated
- 6 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Chronic Dosing (4 Weeks), Four-Period, Five-Treatment, Incomplete Block, Cross-Over, Multi-Center 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
- ClinicalTrials.gov ID
- NCT02105012
- Acronym / sponsor ID
- PT008001
- Conditions
- Asthma
- Keywords
- Mild, moderate persistent, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 1 Sep 2015 (actual)
- Study completion
- 4 Sep 2015 (actual)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Posted 6 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, double-blind, chronic dosing (4 weeks), four-period, five-treatment, incomplete block, cross-over, multicenter 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BD MDI 320 µg | Experimental | Drug: BD MDI 320 µgBudesonide metered dose inhaler (BD MDI) 320 µg (PT008) administered as 2 inhalations BID |
| BD MDI 160 µg | Experimental | Drug: BD MDI 160 µgBD MDI 160 µg (PT008) administered as 2 inhalations BID |
| BD MDI 80 µg | Experimental | Drug: BD MDI 80 µgBD MDI 80 µg (PT008) administered as 2 inhalations BID |
| BD MDI 40 µg | Experimental | Drug: BD MDI 40 µgBD MDI 40 µg (PT008) administered as 2 inhalations BID |
| Placebo MDI | Placebo comparator | Drug: Placebo MDIPlacebo MDI administered as 2 inhalations BID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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 < 85% of predicted normal value
- Reversibility: Increase in FEV1 of ≥ 12% and ≥ 200 mL over the pre-albuterol FEV1 within 30 - 60 minutes after the inhalation of 4 puffs of Ventolin hydrofluoroalkane (HFA)
Key exclusion criteria (13 listed)
- Life-Threatening Asthma: A subject must not have life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within the 12 months prior to screening
- Worsening of Asthma: A subject must not have experienced a worsening of asthma which involved an emergency department visit, hospitalization or use of oral/parenteral corticosteroids within 6 weeks of screening
- Intermittent, Seasonal, or Exercise-Induced Asthma Alone: Subjects with only intermittent, seasonal or exercise-induced asthma are excluded from participation in this study
- Concurrent Respiratory Disease
- Pregnant women or nursing mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BD MDI 320 µgAlso: PT008Budesonide Inhalation Aerosol administered as 2 inhalations BID | Drug | BD MDI 320 µg |
| BD MDI 160 µgAlso: PT008Budesonide Inhalation Aerosol administered as 2 inhalations BID | Drug | BD MDI 160 µg |
| BD MDI 80 µgAlso: PT008Budesonide Inhalation Aerosol administered as 2 inhalations BID | Drug | BD MDI 80 µg |
| BD MDI 40 µgAlso: PT008Budesonide Inhalation Aerosol administered as 2 inhalations BID | Drug | BD MDI 40 µg |
| Placebo MDIPlacebo MDI administered as 2 inhalations BID | Drug | Placebo MDI |
Primary outcome
Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period
Time frame: Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)
Change from baseline in morning pre-dose trough Forced Expiratory Volume in 1 second (FEV1) at the end of the Treatment Period.
4 secondary outcomes
Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
Time frame: Baseline to Last 7 Days of Treatment Period
Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
Time frame: Baseline to Last 7 Days of Treatment Period
Change From Baseline in Mean Number of Puffs of Rescue Ventolin HFA
Time frame: Baseline to Last 7 Days of Treatment
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score
Time frame: Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Dorinsky, MD, FCCP study director
Pearl Therapeutics, Inc.
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BD MDI 320 µg, BD MDI 160 µg and BD MDI 80 µg in people with Asthma, run by Pearl Therapeutics, Inc. at 41 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period (time frame: Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.