Chronic Obstructive Pulmonary DiseasePhase 1/2NCT00871182
Study to Evaluate the Safety and Efficacy of Inhaled PT001 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 1/2 study testing Inhaled PT001 and Tiotropium Handihaler in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 6 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of inhaled PT001 compared to placebo and tiotropium in patients with mild to moderate chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Inhaled PT001 and Tiotropium Handihaler
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2009to Sep 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- 40 - 75 years of age
- Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
- COPD diagnosis
- Current/former smokers with at least a 10 pack-year history of cigarette smoking
- Patients with established clinical history of COPD and severity defined as a post-ipratropium FEV1/FVC ratio of ≤0.70 and FEV1 ≥50 and ≤85% of predicted normal at Screening
- Must demonstrate reversibility to ipratropium demonstrated by a >200 mL improvement over baseline and/or >12% and >150 mL improvement over baseline
- Patients willing to stay at study site for at least 24 hours on each test day
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 32Show fewer
- Hospitalized due to poorly controlled COPD within 24 weeks of Screening
- Unable to perform acceptable spirometry
- 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
- Symptomatic prostatic hypertrophy or bladder neck obstruction
- Known narrow-angle glaucoma
- 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 anticholinergics
- History of severe milk protein allergy
- Known or suspected history of alcohol or drug abuse
- Medically unable to withhold short acting bronchodilators for 6-hours
- Use of the medications below in specified time interval prior to Screening: 3 months: depot corticosteroids, intra-articular corticosteroids; 6 weeks: oral corticosteroids, antibiotics administered for a COPD exacerbation; and 1 month: P-glycoprotein inhibitors, CYP450 3A4 inhibitors, ICS >1000 μg/day of fluticasone propionate or equivalent
- The following COPD medications need to be stopped and switched to appropriate replacement therapies: tiotropium, oral beta2 agonists, LABAs, combination corticosteroid/LABAs, theophylline, leukotriene inhibitors,cromoglycate and nedocromil
- 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
- Will enter acute phase of pulmonary rehabilitation program during study
- Unable to comply with study procedures
- Affiliated with Investigator site
- Questionable validity of consent
- Use of investigational study drug/participation in clinical study in the last 30 days or 5 half lives prior to Screening, whichever is longer
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cincinnati VAMC
Cincinnati, Ohio, 45220
National Jewish Health
Denver, Colorado, 80206
Elite Research Institute
Miami, Florida, 33169
Pulmonary and Critical Care Medicine
Omaha, Nebraska, 68198
Pivotal Research Centers
Peoria, Arizona, 85381
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
About this study
Official title: A Randomized, Double-blind, Single Dose, Four-period, Six-treatment, Placebo-controlled, Balanced, Incomplete Block, Cross-over, Study of Four Doses of Inhaled PT001 in Patients With Mild to Moderate COPD, Compared to Open Label Tiotropium
The purpose of this study is to evaluate the safety and efficacy of inhaled PT001 compared to placebo and tiotropium in patients with mild to moderate chronic obstructive pulmonary disease (COPD).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Inhaled PT001, Inhaled Placebo, Tiotropium Handihaler
- Keywords
- COPD, obstructive lung diseases, Tiotropium
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled PT001Drug
single dose, inhaled
Inhaled PlaceboDrug
single dose, inhaled
Tiotropium HandihalerDrug
Also called Spiriva
single dose, tiotropium 18 mcg administered via the Handihaler
| Study group | Role | What they receive |
|---|---|---|
| PT001 18 mcg | Experimental | Inhaled PT001 18 mcg Receives: Drug: Inhaled PT001 |
| PT001 36 mcg | Experimental | Inhaled PT001 36 mcg Receives: Drug: Inhaled PT001 |
| PT001 72 mcg | Experimental | Inhaled PT001 72 mcg Receives: Drug: Inhaled PT001 |
| PT001 144 mcg | Experimental | Inhaled PT001 144 mcg Receives: Drug: Inhaled PT001 |
| Inhaled Placebo | Placebo comparator | Inhaled Placebo Receives: Drug: Inhaled Placebo |
| Tiotropium Handihaler | Active comparator | Tiotropium 18 mcg administered via Handihaler Receives: Drug: Tiotropium Handihaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak improvement in forced expiratory volume in one second (FEV1)
Day 1 serial FEV1 measured over 24 hours
Measured: Day 1
Secondary outcomes (6)
Time to onset of action (>10% improvement in FEV1 from baseline)
Day 1 serial FEV1 measured over 24 hours
Measured: Day 1
Time to peak FEV1
Day 1 serial FEV1 measured over 24 hours
Measured: Day 1
FEV1 area under the curve (AUC) from 0 to 24 hours
Day 1 serial FEV1 measured over 24 hours
Measured: Day 1
FEV1 AUC from 0 to 12 hours
Day 1 serial FEV1 measured over 24 hours
Measured: Day 1
Trough FEV1 at 12 and 24 hours
Day 1 serial FEV1 measured over 24 hours
Measured: Day 1
Peak Improvement in inspiratory capacity (IC)
Day 1 serial IC measured over 24 hours
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionSep 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Colin Reisner, M.D., Study director, Pearl Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871182
- Sponsor's protocol ID
- PT0010801
- Status last verified
- Jun 2013
- First submitted
- 26 Mar 2009
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rennard S, Fogarty C, Reisner C, Fernandez C, Fischer T, Golden M, Rose ES, Darken P, Tardie G, Orevillo C. Randomized study of the safety, pharmacokinetics, and bronchodilatory efficacy of a proprietary glycopyrronium metered-dose inhaler in study patients with chronic obstructive pulmonary disease. BMC Pulm Med. 2014 Jul 16;14:118. doi: 10.1186/1471-2466-14-118.
PubMed 25027304
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single Dose, Four-period, Six-treatment, Placebo-controlled, Balanced, Incomplete Block, Cross-over, Study of Four Doses of Inhaled PT001 in Patients With Mild to Moderate COPD, Compared to Open Label Tiotropium
- ClinicalTrials.gov ID
- NCT00871182
- Acronym / sponsor ID
- PT0010801
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, obstructive lung diseases, Tiotropium
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 30 Mar 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 PT001 compared to placebo and tiotropium in patients with mild to moderate 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 |
|---|---|---|
| PT001 18 mcg | Experimental | Drug: Inhaled PT001Inhaled PT001 18 mcg |
| PT001 36 mcg | Experimental | Drug: Inhaled PT001Inhaled PT001 36 mcg |
| PT001 72 mcg | Experimental | Drug: Inhaled PT001Inhaled PT001 72 mcg |
| PT001 144 mcg | Experimental | Drug: Inhaled PT001Inhaled PT001 144 mcg |
| Inhaled Placebo | Placebo comparator | Drug: Inhaled PlaceboInhaled Placebo |
| Tiotropium Handihaler | Active comparator | Drug: Tiotropium HandihalerTiotropium 18 mcg administered via Handihaler |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed written informed consent
- 40 - 75 years of age
- Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
- COPD diagnosis
- Current/former smokers with at least a 10 pack-year history of cigarette smoking
Key exclusion criteria (32 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 PT001single dose, inhaled | Drug | PT001 144 mcg, PT001 18 mcg, PT001 36 mcg, PT001 72 mcg |
| Inhaled Placebosingle dose, inhaled | Drug | Inhaled Placebo |
| Tiotropium HandihalerAlso: Spirivasingle dose, tiotropium 18 mcg administered via the Handihaler | Drug | Tiotropium Handihaler |
Primary outcome
Peak improvement in forced expiratory volume in one second (FEV1)
Time frame: Day 1
Day 1 serial FEV1 measured over 24 hours
6 secondary outcomes
Time to onset of action (>10% improvement in FEV1 from baseline)
Time frame: Day 1
Time to peak FEV1
Time frame: Day 1
FEV1 area under the curve (AUC) from 0 to 24 hours
Time frame: Day 1
FEV1 AUC from 0 to 12 hours
Time frame: Day 1
Trough FEV1 at 12 and 24 hours
Time frame: Day 1
Peak Improvement in inspiratory capacity (IC)
Time frame: Day 1
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 21 Jun 2013.
- Derived from this study: PubMed 25027304Rennard S, Fogarty C, Reisner C, Fernandez C, Fischer T, Golden M, Rose ES, Darken P, Tardie G, Orevillo C. Randomized study of the safety, pharmacokinetics, and bronchodilatory efficacy of a proprietary glycopyrronium metered-dose inhaler in study patients with chronic obstructive pulmonary disease. BMC Pulm Med. 2014 Jul 16;14:118. doi: 10.1186/1471-2466-14-118.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Inhaled PT001 and Tiotropium Handihaler in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 6 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 8 inclusion and 32 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 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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?
Peak improvement in forced expiratory volume in one second (FEV1) (time frame: Day 1). 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 NCT00871182, 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 21 Jun 2013.