COPDPhase 2NCT01043601
Efficacy and Safety of Two Doses of Formoterol Fumarate MDI (PT005) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), Compared to Foradil® Aerolizer® as an Active Control
A Phase 2 study testing Inhaled PT005 and Formoterol Fumarate 12 µg (Foradil Aerolizer) in people with COPD, run by Pearl Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of inhaled formoterol fumarate (7.2 and 9.6 µg ex-actuator) compared to placebo and Foradil Aerolizer in patients with moderate to very 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
- COPD
- What is being tested?
- Inhaled PT005 and Formoterol Fumarate 12 µg (Foradil Aerolizer)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Apr 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
- Fluency in written and spoken English
- 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
- A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values
- Competent at using the inhalation device
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
Show all 22Show fewer
- Hospitalized due to poorly controlled COPD within 12 weeks of Screening
- Poorly controlled COPD, defined as the occurrence of acute worsening of COPD requiring corticosteroids or antibiotics or acute worsening of COPD requiring treatment prescribed by a physician within 6 weeks of screening or between screening and visit 2
- Lower respiratory tract infection requiring antibiotics within 6 weeks of screening
- Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG or uncontrolled hypertension)
- Positive Hepatitis B surface antigen or Hepatitis C antibody
- Cancer that has not been in complete remission for at least 5 years
- History of hypersensitivity to any beta2-agonists or any study drug component
- History of severe milk protein allergy
- Known or suspected history of alcohol or drug abuse
- Medically unable to withhold short acting bronchodilators for 8-hours
- Use of prohibited medications prior to screening and during the study as specified in the protocol
- Receiving long-term-oxygen or nocturnal oxygen therapy for >12 hours a day
- Participation in acute phase of pulmonary rehabilitation within 4 weeks of screening or will enter acute phase of pulmonary rehabilitation program during study
- Unable to comply with study procedures
- Prior participation in a Pearl PT005 study
- Requires use of a spacer due to poor hand-to-breath coordination
Trial locations and contacts
1 site in 1 country.
United States1 site
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
About this study
Official title: A Phase IIb, Multi-center, Randomized, Double-blind, Placebo-controlled, Multi-dose, Four-period, Cross-over Study of Two Doses of Formoterol Fumarate MDI (PT005; 7.2 and 9.6 µg Ex-actuator), Administered Twice Daily for 1 Week in Patients With Moderate to Very Severe COPD, Compared to Open Label Marketed Formoterol Fumarate Inhalation Powder (Foradil® Aerolizer®, 12 µg) as an Active Control
The purpose of this study is to evaluate the safety and efficacy of inhaled formoterol fumarate (7.2 and 9.6 µg ex-actuator) compared to placebo and Foradil Aerolizer in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
- Conditions
- COPD
- Being tested
- Inhaled PT005, Inhaled Placebo, Formoterol Fumarate 12 µg (Foradil Aerolizer)
- 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.
Inhaled PT005Drug
inhaled, twice daily for 1 week duration
Inhaled PlaceboDrug
inhaled, twice daily for 1 week duration
Formoterol Fumarate 12 µg (Foradil Aerolizer)Drug
inhaled, twice daily for 1 week duration
| Study group | Role | What they receive |
|---|---|---|
| Inhaled PT005 7.2 µg | Experimental | Not described Receives: Drug: Inhaled PT005 |
| Inhaled PT005 9.6 µg | Experimental | Not described Receives: Drug: Inhaled PT005 |
| Inhaled Placebo | Placebo comparator | Not described Receives: Drug: Inhaled Placebo |
| Formoterol Fumarate 12 µg (Foradil Aerolizer) | Active comparator | Not described Receives: Drug: Formoterol Fumarate 12 µg (Foradil Aerolizer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours [AUC(0-12)] from test day baseline across the two doses of inhaled PT005 compared with placebo.
Measured: Day 7
Secondary outcomes (2)
Lung Function Measures on Day 7 as measured by spirometry.
Measured: Day 7
Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events of special interest
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Why it stopped: Similar data obtained in another study \[see NCT01085045\], therefore study not implemented.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Charles Fogarty, MD, Principal investigator, Spartanburg Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043601
- Sponsor's protocol ID
- PT0051002
- Status last verified
- Jul 2014
- First submitted
- 5 Jan 2010
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Multi-center, Randomized, Double-blind, Placebo-controlled, Multi-dose, Four-period, Cross-over Study of Two Doses of Formoterol Fumarate MDI (PT005; 7.2 and 9.6 µg Ex-actuator), Administered Twice Daily for 1 Week in Patients With Moderate to Very Severe COPD, Compared to Open Label Marketed Formoterol Fumarate Inhalation Powder (Foradil® Aerolizer®, 12 µg) as an Active Control
- ClinicalTrials.gov ID
- NCT01043601
- Acronym / sponsor ID
- PT0051002
- Conditions
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Similar data obtained in another study \[see NCT01085045\], therefore study not implemented.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 7 Jan 2010 (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 formoterol fumarate (7.2 and 9.6 µg ex-actuator) compared to placebo and Foradil Aerolizer in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Inhaled PT005 7.2 µg | Experimental | Drug: Inhaled PT005 |
| Inhaled PT005 9.6 µg | Experimental | Drug: Inhaled PT005 |
| Inhaled Placebo | Placebo comparator | Drug: Inhaled Placebo |
| Formoterol Fumarate 12 µg (Foradil Aerolizer) | Active comparator | Drug: Formoterol Fumarate 12 µg (Foradil Aerolizer) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed written informed consent
- 40 - 80 years of age
- Fluency in written and spoken English
- 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 (22 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 |
|---|---|---|
| Inhaled PT005inhaled, twice daily for 1 week duration | Drug | Inhaled PT005 7.2 µg, Inhaled PT005 9.6 µg |
| Inhaled Placeboinhaled, twice daily for 1 week duration | Drug | Inhaled Placebo |
| Formoterol Fumarate 12 µg (Foradil Aerolizer)inhaled, twice daily for 1 week duration | Drug | Formoterol Fumarate 12 µg (Foradil Aerolizer) |
Primary outcome
Change in forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours [AUC(0-12)] from test day baseline across the two doses of inhaled PT005 compared with placebo.
Time frame: Day 7
2 secondary outcomes
Lung Function Measures on Day 7 as measured by spirometry.
Time frame: Day 7
Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events of special interest
Time frame: Day 7
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
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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.
Charles Fogarty, MD principal investigator
Spartanburg Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhaled PT005 and Formoterol Fumarate 12 µg (Foradil Aerolizer) in people with COPD, run by Pearl Therapeutics, Inc. at 1 site 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 8 inclusion and 22 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: withdrawn, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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 forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours [AUC(0-12)] from test day baseline across the two doses of inhaled PT005 compared with placebo. (time frame: Day 7). 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 11 Jul 2014.