Chronic Obstructive Pulmonary DiseasePhase 2NCT01349868
PT005 MDI Dose Ranging Versus Foradil Aerolizer Study
A Phase 2 study testing PT005 MDI, Formoterol Fumarate 12 μg (Foradil® Aerolizer®) and Formoterol Fumarate 24 μg (Foradil® Aerolizer®) in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- PT005 MDI, Formoterol Fumarate 12 μg (Foradil® Aerolizer®) and Formoterol Fumarate 24 μg (Foradil® Aerolizer®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2011to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- 40 - 80 years of age
- Clinical history of COPD with airflow limitation that is not fully reversible
- Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
- Current/former smokers with at least a 10 pack-year history of cigarette smoking
- A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70
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- A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values
- Able to change COPD treatment as required by protocol
- Demonstratead reversibility to short acting beta agonist (Ventolin HFA) (> 12% and >150 mL improvement in baseline FEV1 approximately 30 minutes following administration of 4 puffs of Ventolin HFA or > 200 mL improvement in baseline FEV1 30 minutes following administration of 2 puffs of Ventolin HFA)
Who cannot join
- Women who are pregnant or lactating
- Primary diagnosis of asthma
- Alpha-1 antitrypsin deficiency as the cause of COPD
- Active pulmonary diseases
- Prior lung volume reduction surgery
- Abnormal chest X-ray (or CT scan) not due to the presence of COPD
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- Hospitalized due to poorly controlled COPD within 3 months of Screening
- Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
- Cancer that has not been in complete remission for at least 5 years
- Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives
- Other inclusion/exclusion criteria as defined by the protocol
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pearl Investigative Site
Clearwater, Florida
Pearl Investigative Site
Spartanburg, South Carolina
Pearl Investigative Site
Tampa, Florida
About this study
Official title: A Randomized, Double-Blind, Single Dose, Six-Treatment, Placebo-Controlled, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Three Doses of PT005, in Patients With Moderate to Severe COPD, Compared With Foradil® Aerolizer® (12 and 24 µg Open-Label) as Active Controls
The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- PT005 MDI, Formoterol Fumarate 12 μg (Foradil® Aerolizer®), Formoterol Fumarate 24 μg (Foradil® Aerolizer®), Placebo MDI
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT005 MDIDrug
PT005 MDI taken as two inhalations
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)Drug
Also called Foradil® Aerolizer®
Taken as 1 capsule. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
Formoterol Fumarate 24 μg (Foradil® Aerolizer®)Drug
Also called Foradil® Aerolizer®
Taken as 2 capsules. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
Placebo MDIOther
Matching placebo to PT005 MDI taken as two inhalations
| Study group | Role | What they receive |
|---|---|---|
| PT005 MDI (Dose 1) | Experimental | PT005 MDI (Dose 1) Receives: Drug: PT005 MDI |
| PT005 MDI (Dose 2) | Experimental | PT005 MDI (Dose 2) Receives: Drug: PT005 MDI |
| PT005 MDI (Dose 3) | Experimental | PT005 MDI (Dose 3) Receives: Drug: PT005 MDI |
| Placebo MDI | Placebo comparator | Placebo MDI Receives: Other: Placebo MDI |
| Formoterol Fumarate 12 μg (Foradil® Aerolizer®) | Active comparator | Formoterol fumarate inhalation powder 12 μg Receives: Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) |
| Formoterol Fumarate 24 μg (Foradil® Aerolizer®) | Active comparator | Formoterol fumarate inhalation powder 24 μg Receives: Drug: Formoterol Fumarate 24 μg (Foradil® Aerolizer®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1 AUC0-12 from test day baseline across the three doses of inhaled PT005 compared with placebo
The primary objective of this study is to demonstrate efficacy relative to placebo of PT005 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this study. To this end, each dose of PT005 MDI will be compared to placebo with respect to the primary efficacy endpoint, the change in FEV1 AUC0-12 from baseline.
Measured: 1 Day
Secondary outcomes (2)
Characterize the dose-response curve of PT005 MDI
The secondary objective of the study is to characterize the dose-response curve of PT005 MDI, to conduct a non-inferiority assessment comparing PT005 MDI within the range of doses evaluated in this study to open-label Foradil Aerolizer 12 µg, and to select the most appropriate dose of PT005 MDI to carry forward into Phase III clinical studies
Measured: 1 Day
Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349868
- Sponsor's protocol ID
- PT005003
- Status last verified
- Sep 2012
- First submitted
- 5 May 2011
- Last updated
- 12 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Single Dose, Six-Treatment, Placebo-Controlled, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Three Doses of PT005, in Patients With Moderate to Severe COPD, Compared With Foradil® Aerolizer® (12 and 24 µg Open-Label) as Active Controls
- ClinicalTrials.gov ID
- NCT01349868
- Acronym / sponsor ID
- PT005003
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 9 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PT005 MDI (Dose 1) | Experimental | Drug: PT005 MDIPT005 MDI (Dose 1) |
| PT005 MDI (Dose 2) | Experimental | Drug: PT005 MDIPT005 MDI (Dose 2) |
| PT005 MDI (Dose 3) | Experimental | Drug: PT005 MDIPT005 MDI (Dose 3) |
| Placebo MDI | Placebo comparator | Other: Placebo MDIPlacebo MDI |
| Formoterol Fumarate 12 μg (Foradil® Aerolizer®) | Active comparator | Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)Formoterol fumarate inhalation powder 12 μg |
| Formoterol Fumarate 24 μg (Foradil® Aerolizer®) | Active comparator | Drug: Formoterol Fumarate 24 μg (Foradil® Aerolizer®)Formoterol fumarate inhalation powder 24 μg |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed written informed consent
- 40 - 80 years of age
- Clinical history of COPD with airflow limitation that is not fully reversible
- Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
- Current/former smokers with at least a 10 pack-year history of cigarette smoking
Key exclusion criteria (11 listed)
- Women who are pregnant or lactating
- Primary diagnosis of asthma
- Alpha-1 antitrypsin deficiency as the cause of COPD
- Active pulmonary diseases
- Prior lung volume reduction surgery
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 |
|---|---|---|
| PT005 MDIPT005 MDI taken as two inhalations | Drug | PT005 MDI (Dose 1), PT005 MDI (Dose 2), PT005 MDI (Dose 3) |
| Formoterol Fumarate 12 μg (Foradil® Aerolizer®)Also: Foradil® Aerolizer®Taken as 1 capsule. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece | Drug | Formoterol Fumarate 12 μg (Foradil® Aerolizer®) |
| Formoterol Fumarate 24 μg (Foradil® Aerolizer®)Also: Foradil® Aerolizer®Taken as 2 capsules. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece | Drug | Formoterol Fumarate 24 μg (Foradil® Aerolizer®) |
| Placebo MDIMatching placebo to PT005 MDI taken as two inhalations | Other | Placebo MDI |
Primary outcome
Change in FEV1 AUC0-12 from test day baseline across the three doses of inhaled PT005 compared with placebo
Time frame: 1 Day
The primary objective of this study is to demonstrate efficacy relative to placebo of PT005 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this study. To this end, each dose of PT005 MDI will be compared to placebo with respect to the primary efficacy endpoint, the change in FEV1 AUC0-12 from baseline.
2 secondary outcomes
Characterize the dose-response curve of PT005 MDI
Time frame: 1 Day
Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 PT005 MDI, Formoterol Fumarate 12 μg (Foradil® Aerolizer®) and Formoterol Fumarate 24 μg (Foradil® Aerolizer®) in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 3 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 9 inclusion and 11 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 12 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in FEV1 AUC0-12 from test day baseline across the three doses of inhaled PT005 compared with placebo (time frame: 1 Day). 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 12 Sep 2012.