Chronic Obstructive Pulmonary DiseasePhase 1/2NCT00880490
Study to Evaluate the Safety and Efficacy of Inhaled PT005 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 1/2 study testing Inhaled PT005 and Formoterol Fumarate 12 mcg (Foradil Aerolizer) in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 5 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 compared to placebo and Formoterol Fumarate (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?
- Inhaled PT005 and Formoterol Fumarate 12 mcg (Foradil Aerolizer)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Nov 2008to May 2009
- Phase
- Phase 1/2
- 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-salbutamol FEV1/FVC ratio of < or = 0.70
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- A measured post-salbutamol FEV1 > or = 40 and < or = 80% of predicted normal values
- Demonstrated reversibility to a short acting beta agonist by either >12% and >150 ml improvement in baseline FEV1, 30 minutes following administration of 4 puffs of salbutamol MDI or an absolute improvement of >200 ml in baseline FEV1, 30 minutes following administration of 4 puffs of salbutamol MDI.
- 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
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- Hospitalized due to poorly controlled COPD within 24 weeks of Screening
- Poorly controlled COPD in prior 6-weeks, defined as the occurrence of acute worsening of COPD requiring corticosteroids or antibiotics or acute worsening of COPD requiring treatment prescribed by a physician
- Clinically significant medical conditions
- Lower respiratory tract infection requiring antibiotics in past 6 weeks
- Clinically significant abnormal ECG
- Clinically significant 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 the medications below in specified time interval prior to Screening: 12-weeks: depot corticosteroids, intra-articular corticosteroids; 4 weeks: ICS >1000 μg/day of fluticasone propionate or equivalent, non-potassium sparing diuretics, P-glycoprotein inhibitors, CYP3A4 inhibitors; 1 week: tiotropium; 48 hours: oral beta agonists, long acting beta agonists, theophylline, zariflukast, montelukast, zileuton; 8 hours: ipratropium or ipratropium/salbutamol combination product, inhaled short acting beta agonists, xanthine containing foods
- Use of the following medications is prohibited: tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, beta-adrenergic antagonists, anticonvulsants (barbiturates,hydantoins, and carbamazepine and phenothiazines
- Receiving long-term-oxygen or nocturnal oxygen therapy for >12 hours a day
- Diagnosis of sleep apnea that is uncontrolled
- Participation in acute phase of pulmonary rehabilitation in prior 4 weeks or will enter acute phase of pulmonary rehabilitation program during study
- Unable to comply with study procedures
- Affiliated with Investigator site
- Questionable validity of consent
- A positive drug of abuse test at Screening lives prior to Screening, whichever is longer
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Australia3 sites
Australian Clinical Research Organisation
Auchenflower, Queensland, 4066
Woolcock Institute of Medical Research
Glebe, New South Wales, 2037
Mater Hospital
South Brisbane, Queensland, 4101
New Zealand2 sites
Primorus Clinical Trials
Christchurch, 8014
P3 Research
Wellington, 6035
About this study
Official title: A Randomized, Double-blind, Five-period, Placebo and Active-controlled,Cross-over, Multi-centre, Study Evaluating Single Administration of Three Doses of Inhaled PT005 in Patients With Moderate-to-Severe COPD, Compared to Open- Label Marketed Formoterol (FORADIL® AEROLIZER®) as an Active Control
The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 compared to placebo and Formoterol Fumarate (Foradil Aerolizer) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Inhaled PT005, Inhaled placebo, Formoterol Fumarate 12 mcg (Foradil Aerolizer)
- 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.
Inhaled PT005Drug
single dose, inhaled
Inhaled PT005Drug
single dose, inhaled
Inhaled PT005Drug
single dose, inhaled
Inhaled placeboDrug
single dose, inhaled
Formoterol Fumarate 12 mcg (Foradil Aerolizer)Drug
Also called Foradil Aerolizer
single dose, Formoterol Fumarate 12 mcg administered via the Aerolizer
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Inhaled PT005 2.4 mcg Receives: Drug: Inhaled PT005 |
| 2 | Experimental | Inhaled PT005 4.8 mcg Receives: Drug: Inhaled PT005 |
| 3 | Experimental | Inhaled PT005 9.6 mcg Receives: Drug: Inhaled PT005 |
| 4 | Placebo comparator | Inhaled Placebo Receives: Drug: Inhaled placebo |
| 5 | Active comparator | Formoterol Fumarate 12 mcg (Foradil Aerolizer) Receives: Drug: Formoterol Fumarate 12 mcg (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 three doses of inhaled PT005 compared with placebo.
Measured: Serial FEV1 measured over 12 hours
Secondary outcomes (6)
Time to onset of action (>10% improvement in FEV1 from baseline)
Measured: Serial FEV1 measured over 12 hours
Peak FEV1
Measured: Serial FEV1 measured over 12 hours
Trough FEV1
Measured: Serial FEV1 measured over 12 hours
Peak inspiratory capacity (IC)
Measured: Serial IC measured over 12 hours
Peak expiratory flow rate (PEFR)
Measured: Serial PEFR measured over 12 hours
Forced vital capacity (FVC)
Measured: Serial FVC measured over 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startNov 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Colin Reisner, M.D., Study director, Pearl Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880490
- Sponsor's protocol ID
- PT0050801
- Status last verified
- Oct 2010
- First submitted
- 9 Apr 2009
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Quinn D, Seale JP, Reisner C, Fischer T, Golden M, Fernandez C, Darken P, St Rose E, Thomas M, Tardie G, Orevillo C. A randomized study of formoterol fumarate in a porous particle metered-dose inhaler in patients with moderate-to-severe COPD. Respir Med. 2014 Sep;108(9):1327-35. doi: 10.1016/j.rmed.2014.06.009. Epub 2014 Jul 3.
PubMed 25060541
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Five-period, Placebo and Active-controlled,Cross-over, Multi-centre, Study Evaluating Single Administration of Three Doses of Inhaled PT005 in Patients With Moderate-to-Severe COPD, Compared to Open- Label Marketed Formoterol (FORADIL® AEROLIZER®) as an Active Control
- ClinicalTrials.gov ID
- NCT00880490
- Acronym / sponsor ID
- PT0050801
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 13 Apr 2009 (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 compared to placebo and Formoterol Fumarate (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
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Inhaled PT005Inhaled PT005 2.4 mcg |
| 2 | Experimental | Drug: Inhaled PT005Inhaled PT005 4.8 mcg |
| 3 | Experimental | Drug: Inhaled PT005Inhaled PT005 9.6 mcg |
| 4 | Placebo comparator | Drug: Inhaled placeboInhaled Placebo |
| 5 | Active comparator | Drug: Formoterol Fumarate 12 mcg (Foradil Aerolizer)Formoterol Fumarate 12 mcg (Foradil Aerolizer) |
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
- 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 (27 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 PT005single dose, inhaled | Drug | 1 |
| Inhaled PT005single dose, inhaled | Drug | 2 |
| Inhaled PT005single dose, inhaled | Drug | 3 |
| Inhaled placebosingle dose, inhaled | Drug | 4 |
| Formoterol Fumarate 12 mcg (Foradil Aerolizer)Also: Foradil Aerolizersingle dose, Formoterol Fumarate 12 mcg administered via the Aerolizer | Drug | 5 |
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 three doses of inhaled PT005 compared with placebo.
Time frame: Serial FEV1 measured over 12 hours
6 secondary outcomes
Time to onset of action (>10% improvement in FEV1 from baseline)
Time frame: Serial FEV1 measured over 12 hours
Peak FEV1
Time frame: Serial FEV1 measured over 12 hours
Trough FEV1
Time frame: Serial FEV1 measured over 12 hours
Peak inspiratory capacity (IC)
Time frame: Serial IC measured over 12 hours
Peak expiratory flow rate (PEFR)
Time frame: Serial PEFR measured over 12 hours
Forced vital capacity (FVC)
Time frame: Serial FVC measured over 12 hours
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 13 Oct 2010.
- Derived from this study: PubMed 25060541Quinn D, Seale JP, Reisner C, Fischer T, Golden M, Fernandez C, Darken P, St Rose E, Thomas M, Tardie G, Orevillo C. A randomized study of formoterol fumarate in a porous particle metered-dose inhaler in patients with moderate-to-severe COPD. Respir Med. 2014 Sep;108(9):1327-35. doi: 10.1016/j.rmed.2014.06.009. Epub 2014 Jul 3.
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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.
Colin Reisner, M.D. study director
Pearl Therapeutics, Inc.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Inhaled PT005 and Formoterol Fumarate 12 mcg (Foradil Aerolizer) in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 5 sites in 2 countries.
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 27 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 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, New Zealand. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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 three doses of inhaled PT005 compared with placebo. (time frame: Serial FEV1 measured over 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00880490, which also lists 1 linked publication.
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 13 Oct 2010.