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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00880490




Registration number
NCT00880490
Ethics application status
Date submitted
9/04/2009
Date registered
10/04/2009
Date last updated
11/10/2010

Titles & IDs
Public title
Study to Evaluate the Safety and Efficacy of Inhaled PT005 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Scientific 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
Secondary ID [1] 0 0
PT0050801
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Chronic Obstructive Pulmonary Disease 0 0
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Inhaled PT005
Treatment: Drugs - Inhaled PT005
Treatment: Drugs - Inhaled PT005
Treatment: Drugs - Inhaled placebo
Treatment: Drugs - Formoterol Fumarate 12 mcg (Foradil Aerolizer)
Treatment: Drugs - Inhaled PT005
Treatment: Drugs - Inhaled PT005
Treatment: Drugs - Inhaled PT005
Treatment: Drugs - Inhaled placebo
Treatment: Drugs - Formoterol Fumarate 12 mcg (Foradil Aerolizer)
Treatment: Drugs - Inhaled PT005
Treatment: Drugs - Inhaled PT005
Treatment: Drugs - Inhaled PT005
Treatment: Drugs - Inhaled placebo
Treatment: Drugs - Formoterol Fumarate 12 mcg (Foradil Aerolizer)

Experimental: 1 - Inhaled PT005 2.4 mcg

Experimental: 2 - Inhaled PT005 4.8 mcg

Experimental: 3 - Inhaled PT005 9.6 mcg

Placebo Comparator: 4 - Inhaled Placebo

Active Comparator: 5 - Formoterol Fumarate 12 mcg (Foradil Aerolizer)

Experimental: 1 - Inhaled PT005 2.4 mcg

Experimental: 2 - Inhaled PT005 4.8 mcg

Experimental: 3 - Inhaled PT005 9.6 mcg

Placebo Comparator: 4 - Inhaled Placebo

Active Comparator: 5 - Formoterol Fumarate 12 mcg (Foradil Aerolizer)

Experimental: 1 - Inhaled PT005 2.4 mcg

Experimental: 2 - Inhaled PT005 4.8 mcg

Experimental: 3 - Inhaled PT005 9.6 mcg

Placebo Comparator: 4 - Inhaled Placebo

Active Comparator: 5 - Formoterol Fumarate 12 mcg (Foradil Aerolizer)


Treatment: Drugs: Inhaled PT005
single dose, inhaled

Treatment: Drugs: Inhaled PT005
single dose, inhaled

Treatment: Drugs: Inhaled PT005
single dose, inhaled

Treatment: Drugs: Inhaled placebo
single dose, inhaled

Treatment: Drugs: Formoterol Fumarate 12 mcg (Foradil Aerolizer)
single dose, Formoterol Fumarate 12 mcg administered via the Aerolizer

Treatment: Drugs: Inhaled PT005
single dose, inhaled

Treatment: Drugs: Inhaled PT005
single dose, inhaled

Treatment: Drugs: Inhaled PT005
single dose, inhaled

Treatment: Drugs: Inhaled placebo
single dose, inhaled

Treatment: Drugs: Formoterol Fumarate 12 mcg (Foradil Aerolizer)
single dose, Formoterol Fumarate 12 mcg administered via the Aerolizer

Treatment: Drugs: Inhaled PT005
single dose, inhaled

Treatment: Drugs: Inhaled PT005
single dose, inhaled

Treatment: Drugs: Inhaled PT005
single dose, inhaled

Treatment: Drugs: Inhaled placebo
single dose, inhaled

Treatment: Drugs: Formoterol Fumarate 12 mcg (Foradil Aerolizer)
single dose, Formoterol Fumarate 12 mcg administered via the Aerolizer

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Serial FEV1 measured over 12 hours
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Serial FEV1 measured over 12 hours
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
Serial FEV1 measured over 12 hours
Secondary outcome [1] 0 0
Time to onset of action (>10% improvement in FEV1 from baseline)
Timepoint [1] 0 0
Serial FEV1 measured over 12 hours
Secondary outcome [2] 0 0
Peak FEV1
Timepoint [2] 0 0
Serial FEV1 measured over 12 hours
Secondary outcome [3] 0 0
Trough FEV1
Timepoint [3] 0 0
Serial FEV1 measured over 12 hours
Secondary outcome [4] 0 0
Peak inspiratory capacity (IC)
Timepoint [4] 0 0
Serial IC measured over 12 hours
Secondary outcome [5] 0 0
Peak expiratory flow rate (PEFR)
Timepoint [5] 0 0
Serial PEFR measured over 12 hours
Secondary outcome [6] 0 0
Forced vital capacity (FVC)
Timepoint [6] 0 0
Serial FVC measured over 12 hours
Secondary outcome [7] 0 0
Time to onset of action (>10% improvement in FEV1 from baseline)
Timepoint [7] 0 0
Serial FEV1 measured over 12 hours
Secondary outcome [8] 0 0
Peak FEV1
Timepoint [8] 0 0
Serial FEV1 measured over 12 hours
Secondary outcome [9] 0 0
Trough FEV1
Timepoint [9] 0 0
Serial FEV1 measured over 12 hours
Secondary outcome [10] 0 0
Peak inspiratory capacity (IC)
Timepoint [10] 0 0
Serial IC measured over 12 hours
Secondary outcome [11] 0 0
Peak expiratory flow rate (PEFR)
Timepoint [11] 0 0
Serial PEFR measured over 12 hours
Secondary outcome [12] 0 0
Forced vital capacity (FVC)
Timepoint [12] 0 0
Serial FVC measured over 12 hours
Secondary outcome [13] 0 0
Time to onset of action (>10% improvement in FEV1 from baseline)
Timepoint [13] 0 0
Serial FEV1 measured over 12 hours
Secondary outcome [14] 0 0
Peak FEV1
Timepoint [14] 0 0
Serial FEV1 measured over 12 hours
Secondary outcome [15] 0 0
Trough FEV1
Timepoint [15] 0 0
Serial FEV1 measured over 12 hours
Secondary outcome [16] 0 0
Peak inspiratory capacity (IC)
Timepoint [16] 0 0
Serial IC measured over 12 hours
Secondary outcome [17] 0 0
Peak expiratory flow rate (PEFR)
Timepoint [17] 0 0
Serial PEFR measured over 12 hours
Secondary outcome [18] 0 0
Forced vital capacity (FVC)
Timepoint [18] 0 0
Serial FVC measured over 12 hours

Eligibility
Key inclusion criteria
- 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

- 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
Minimum age
40 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research - Glebe
Recruitment hospital [2] 0 0
Australian Clinical Research Organisation - Auchenflower
Recruitment hospital [3] 0 0
Mater Hospital - South Brisbane
Recruitment postcode(s) [1] 0 0
2037 - Glebe
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pearl Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/show/NCT00880490
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Colin Reisner, M.D.
Address 0 0
Pearl Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications