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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01085045




Registration number
NCT01085045
Ethics application status
Date submitted
9/03/2010
Date registered
11/03/2010
Date last updated
26/04/2017

Titles & IDs
Public title
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (7 Days), Four-Period, Eight-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Two Doses of PT003, Two Doses of PT005 and One Dose of PT001 in Patients With Moderate to Very Severe COPD, Compared With Foradil® Aerolizer® (12 µg, Open-Label) and Spiriva® Handihaler® (18 µg, Open-Label) as Active Controls
Secondary ID [1] 0 0
PT0031002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - PT003 MDI
Treatment: Drugs - PT005 MDI
Treatment: Drugs - Placebo MDI
Treatment: Drugs - Tiotropium bromide 18 µg (Spiriva Handihaler®)
Treatment: Drugs - Formoterol Fumarate 12 µg (Foradil® Aerolizer®)
Treatment: Drugs - PT001 MDI

Experimental: Inhaled PT003 (Dose 1) - PT003 MDI Dose 1

Experimental: Inhaled PT003 (Dose 2) - PT003 MDI Dose 2

Experimental: Inhaled PT005 (Dose 1) - PT005 MDI Dose 1

Experimental: Inhaled PT005 (Dose 2) - PT005 MDI Dose 2

Placebo comparator: Inhaled Placebo - Placebo MDI

Active comparator: Tiotropium bromide 18 µg (Spiriva Handihaler®) - Tiotropium Bromide inhalation powder

Active comparator: Formoterol Fumarate 12 µg (Foradil® Aerolizer®) - Formoterol fumarate inhalation powder 12 µg

Experimental: Inhaled PT001 (Dose 1) - PT001 MDI Dose 1


Treatment: Drugs: PT003 MDI
Inhaled PT003 MDI administered as two puffs BID for 7 days

Treatment: Drugs: PT005 MDI
Inhaled PT005 MDI administered as two puffs BID for 7 days

Treatment: Drugs: Placebo MDI
Inhaled placebo administered as two puffs BID for 7 days

Treatment: Drugs: Tiotropium bromide 18 µg (Spiriva Handihaler®)
Inhaled tiotropium bromide 18 µg (Spiriva Handihaler®) administered QD for 7 days

Treatment: Drugs: Formoterol Fumarate 12 µg (Foradil® Aerolizer®)
Inhaled formoterol fumarate 12 µg (Foradil® Aerolizer®) administered BID for 7 days

Treatment: Drugs: PT001 MDI
Inhaled PT001 MDI administered as two puffs BID for 7 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
FEV1 AUC 0-12 on Day 7
Timepoint [1] 0 0
"Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7
Secondary outcome [1] 0 0
Peak Change From BL in FEV1 on Day 1
Timepoint [1] 0 0
Day 1
Secondary outcome [2] 0 0
Peak Change From BL in FEV1 on Day 7
Timepoint [2] 0 0
Day 7
Secondary outcome [3] 0 0
Peak Change From BL in Inspiratory Capacity on Day 1
Timepoint [3] 0 0
Day 1
Secondary outcome [4] 0 0
Peak Change From BL IC on Day 7
Timepoint [4] 0 0
Day 7
Secondary outcome [5] 0 0
Time to Onset of Action >=10% Improvement in FEV1 on Day 1
Timepoint [5] 0 0
Day 1
Secondary outcome [6] 0 0
Percentage of Patients Achieving >=12% Improvement in FEV1 on Day 1
Timepoint [6] 0 0
Day 1
Secondary outcome [7] 0 0
Change in Morning Pre-dose FEV1 on Day 7
Timepoint [7] 0 0
Day 7
Secondary outcome [8] 0 0
12 hr Post-dose Trough FEV1 on Day 7
Timepoint [8] 0 0
Day 7
Secondary outcome [9] 0 0
Change From BL in Mean Morning Pre-dose Daily Peak Flow Rate on Day 7
Timepoint [9] 0 0
Day 7
Secondary outcome [10] 0 0
Change From BL in Mean Morning Post-dose Daily Peak Flow Rate on Day 7
Timepoint [10] 0 0
Day 7
Secondary outcome [11] 0 0
Change From BL in Mean Evening Pre-dose Daily Peak Flow Rate on Day 7
Timepoint [11] 0 0
Day 7
Secondary outcome [12] 0 0
Change From BL in Mean Evening Post-dose Daily Peak Flow Rate on Day 7
Timepoint [12] 0 0
Day 7

Eligibility
Key inclusion criteria
* 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
* 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
Minimum age
40 Years
Maximum age
80 Years
Sex
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 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 protocol defined inclusion/exclusion criteria may apply

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 analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
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
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2010
Sample size
Target
Accrual to date
Final
118
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Austrials - Caringbah
Recruitment hospital [2] 0 0
Woolcock - Glebe
Recruitment hospital [3] 0 0
Austrials - Hornsby
Recruitment hospital [4] 0 0
Austrials - Auchenflower
Recruitment hospital [5] 0 0
Q-Pharm - Herston
Recruitment hospital [6] 0 0
Respiratory Research Foundation - Burnside War Memorial Hospital - Adelaide
Recruitment hospital [7] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [8] 0 0
Lung Institute of WA - Nedlands
Recruitment postcode(s) [1] 0 0
2229 - Caringbah
Recruitment postcode(s) [2] 0 0
2037 - Glebe
Recruitment postcode(s) [3] 0 0
2077 - Hornsby
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
4006 - Herston
Recruitment postcode(s) [6] 0 0
- Adelaide
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
6006 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Oregon
Country [4] 0 0
United States of America
State/province [4] 0 0
South Carolina
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland
Country [6] 0 0
New Zealand
State/province [6] 0 0
Waikato
Country [7] 0 0
New Zealand
State/province [7] 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, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.
Trial website
https://clinicaltrials.gov/study/NCT01085045
Trial related presentations / publications
Reisner C, Fabbri LM, Kerwin EM, Fogarty C, Spangenthal S, Rabe KF, Ferguson GT, Martinez FJ, Donohue JF, Darken P, St Rose E, Orevillo C, Strom S, Fischer T, Golden M, Dwivedi S. A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease. Respir Res. 2017 Jan 6;18(1):8. doi: 10.1186/s12931-016-0491-8. Erratum In: Respir Res. 2017 Aug 21;18(1):158. doi: 10.1186/s12931-017-0638-2.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01085045