NA

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-056-15
• Date of registration: 04/07/2016
• Prospective Registration: No
• Primary sponsor: Pearl Therapeutics Inc.,
• Public title: NA
• Scientific title: A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF PT010 RELATIVE TO PT003 AND PT009 ON COPD EXACERBATIONS OVER A 52-WEEK TREATMENT PERIOD IN SUBJECTS WITH MODERATE TO VERY SEVERE COPD
• Date of first enrolment: 21/03/2016
• Target sample size: 240
• Recruitment status: Complete
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=056-15
• Study type: Interventional
• Study design: This is a randomized, double-blind, multi-center, parallel group study to assess the efficacy and safety of BGF MDI 320/14.4/9.6 μg and BGF MDI 160/14.4/9.6 μg relative to GFF MDI 14.4/9.6 μg and BFF MDI 320/9.6 μg over a 52-week treatment period in approximately 8,000 subjects with moderate to very severe COPD with an increased risk of experiencing a COPD exacerbation and that remain symptomatic on the COPD Assessment Test (CAT ≥ 10) on two or more inhaled maintenance treatments.; To be considered eligible for the study, subjects must have documented history of COPD exacerbations; subjects with a post-bronchodilator FEV1 < 50% of predicted normal must have ≥ 1 moderate or severe COPD exacerbation in the previous 12 months. Subjects with a post-bronchodilator FEV1 ≥ 50% of predicted normal must have a documented history of ≥ 2 moderate exacerbations or a documented history of ≥ 1 severe COPD exacerbation in the pre
• Phase: III

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Honduras, Hungary, Italy, Japan, Korea South, Mexico, Netherlands, New Zealand, Poland, Russian Federation, Serbia, Spain, Sweden, Taiwan, United States

Contacts

• Name: Elizabeth Lopez Rospigliosi
• Affiliation: SYNEOS HEALTH PERU S.R.L.

• Name: Elizabeth Lopez Rospigliosi
• Affiliation: SYNEOS HEALTH PERU S.R.L.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Give their signed written informed consent to participate.
2. Are at least 40 years of age and no older than 80 years at Visit 1.
3. A female is eligible to enter and participate in the study if she is of:
a. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal)
b. Childbearing potential, has a negative serum pregnancy test at Visit 1, and agrees to one of the following acceptable contraceptive methods used consistently and correctly as outlined below (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study – from Visit 1 (Screening) until 14 days after the Final Visit):
− Complete abstinence from intercourse (when it is preferred and usual lifestyle of the patient); or
− Implants of levonorgestrel inserted for at least 1 month prior to the study drug administration but not beyond the third successive year following insertion; or
− Injectable progestogen administered for at least 1 month prior to study drug administration; or
− Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study drug administration; or
− Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or
− An intrauterine device, inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or
− Estrogenic vaginal ring; or
− Percutaneous contraceptive patches.
Note: The acceptable contraceptive methods listed above are subject to locally approved contraceptive methods.
4. COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) [Celli, 2004] or by locally applicable guidelines, e.g., JRS Guidelines [JRS, 2013] characterized by:
− Progressive airflow limitation associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking.
5. Tobacco Use: Current or former smokers with a history of at least 10 pack-years of cigarette smoking. [Number of pack-years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years represent 10 pack-years)].
6. COPD Severity: Subjects with an established clinical history of COPD and severity defined as:

− At Visit 1, FEV1/FVC ratio must be <0.70 and FEV1 must be <65% predicted normal value calculated using NHANES III reference equations (Or reference norms applicable to other regions, e.g., for Japan, use JRS reference equations; [JRS, 2013]).
− At Visit 2, post-bronchodilator FEV1/FVC ratio of <0.70 and post-bronchodilator FEV1 must be ≥25% to <65% predicted normal value, calculated using NHANES III reference equations (Or reference norms applicable to other regions, e.g., for Japan, use JRS reference equations [JRS, 2013]).
− At Visit 4, the average of the -60 min and -30 min pre-dose FEV1 assessments must be <65% predicted normal value, calculated using NHANES III reference equations (Or reference norms applicable to other regions, e.g., for Japan, use JRS reference equations [JRS, 2013]).
&
Exclusion criteria:
1. Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject’s ability to participate in the study.
2. Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
3. Respiratory:
a. Asthma: Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
b. Alpha-1 Antitrypsin Deficiency: Subjects who have alpha-1 antitrypsin deficiency as the cause of COPD.
c. Other Respiratory Disorders: Subjects who have other active pulmonary disease such as active tuberculosis, lung cancer, significant bronchiectasis (high resolution CT evidence of bronchiectasis that causes repeated acute exacerbations), sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea (i.e., in the opinion of the Investigator severity of the disorder would impact the conduct of the study). Note: Allergic rhinitis is not exclusionary.
d. Lung Volume Reduction: Subjects who have undergone lung volume reduction surgery, lobectomy or bronchoscopic lung volume reduction (endobronchial blockers, airway bypass, endobronchial valves, thermal vapor ablation, biological sealants, and airway implants) within 1 year of Visit 1.
e. Hospitalization: Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
f. Poorly Controlled COPD: Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
Note: Subjects who are steroid dependent and maintained on an equivalent of 5 mg prednisone per day or 10 mg every other day for at least 3 months prior to Visit 1 are eligible for enrollment providing the dose of oral steroids remains stable during the Screening Period Visit 1 through Visit 4.
g. Lower Respiratory Tract Infection: Subjects who had lower respiratory tract infections that required antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
h. Other Respiratory tract infections that have not resolved at least 7 days prior to Screening
The other criteria for exclusion are described in the protocol


Age minimum: 40
Age maximum: 80
Gender: Both

Health Condition(s) or Problem(s) studied

-J44 Other chronic obstructive pulmonary disease
Other chronic obstructive pulmonary disease

Other chronic obstructive pulmonary disease

J44

Intervention(s)

Group name:x Type of group;1 N° of participants:0 Intervention(s) description:x

Source(s) of Monetary Support

ASTRAZENECA PERU S.A.

Ethics review

Status: Approved
Approval date: 20/07/2015
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 20/08/2015
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 18/11/2015
Contact:

[e-mail]

Hospital Cayetano Heredia

97254626

[e-mail]

Status: Approved
Approval date: 25/02/2016
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 26/02/2016
Contact:

[e-mail]

Hospital Nacional Guillermo Almenara Irigoyen - EsSalud

999436950

[e-mail]

Status: Approved
Approval date: 23/02/2017
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 02/05/2017
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Status: Approved
Approval date: 19/01/2018
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 20/03/2018
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Results

• Results available: Yes
• Date Completed: 22/07/2019