Phase IV O2 Consumption study in COPD patients.

Study identifier:D589CC00014

ClinicalTrials.gov identifier:NCT02533505

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 4, Randomized, Double-blind, Multicenter, Placebo-Controlled Two Way Cross-Over Study to Evaluate Changes in Oxygen Consumption and Cardiac Function in COPD Patients with Resting Hyperinflation After Administration of Symbicort pMDI 160/4.5 μg.

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 4

Healthy volunteers

Study drug

Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg Inhalation aerosol, Matching Placebo pMDI 160/4.5 μg

Sex

All

Actual Enrollment

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 25 Aug 2015

Primary Completion Date: 12 Aug 2016

Study Completion Date: 12 Aug 2016

Study design

Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2018 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1. Signing of the informed consent form (ICF) prior to any study specific procedures, including withholding of medications.
2. Male or female, aged 40 to 80 years, inclusive, at Screening (Visit 1).
3. Has a clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014 guidelines with a post bronchodilator FEV1/FVC <0.7 at Screening (Visit 1).
4. Has a post-bronchodilator FEV1 ≤65% of predicted value at Screening (Visit 1). National Health and Nutrition Examination Survey (NHANES) predicted normal standards will be used for all subjects.
5. Has an increase in IC of >10% after the administration of 1 inhalation of open-label Symbicort pMDI administered with a spacer at Screening (Visit 1).
6. Has a cigarette smoking history of more than 10 pack-years (number of cigarettes smoked per day × number of years smoked)/20).
7. Be able to understand and comply with study requirements, as judged by the Investigator.

Exclusion Criteria

1. Subject is an employee or relative of an employee involved in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
2. Previous enrollment or randomization in this study.
3. Participation in another clinical study with an investigational product (IP) during the last 30 days prior to Screening (Visit 1).
4. Subjects who are unable to discontinue their regular chronic COPD medications (including LAMAs and/or LABA/ICS) and/or who are unable or unwilling to comply with study requirements.
5. Subjects who are taking uLABAs (indacaterol, vilanterol) or uLABA-containing products.
6. Subjects who are taking PDE-4 inhibitors (roflumilast).
7. Subjects who are taking oral corticosteroids on a chronic, regular basis.
8. Subjects using daytime oxygen therapy.
9. Subjects who are currently pregnant (confirmed with positive pregnancy test) or breast feeding.
10. History of respiratory tract infection (including the upper respiratory tract) and/or pulmonary exacerbation within 6 weeks prior to Screening (Visit 1).
11. Pulmonary resection or lung volume reduction surgery within 12 months prior to Screening (Visit 1), or history of lung transplantation, or, in the Investigator’s opinion, the subject may need thoracotomy or other lung surgery during the study.
12. History or current diagnosis of asthma and/or alpha 1 anti-trypsin deficiency.
13. Known active tuberculosis.
14. History of interstitial lung or massive pulmonary thromboembolic disease.
15. History of bronchiectasis secondary to respiratory diseases other than COPD (eg, cystic fibrosis, Kartagener’s syndrome, etc).
16. Any clinically significant disease or disorder (eg, cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, psychiatric, major physical impairment) which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, may influence the results of the study, or may affect the subject’s ability to participate in the study.
17. Recent (within 12 months prior to Screening [Visit 1]) history of myocardial infarction, recent history of heart failure (New York Heart Association [NYHA] class III and IV, pulmonary edema, and/or cardiac arrhythmia.
18. Previous or current history of lung cancer.
19. History of cancer (within 5 years prior to Visit 1), except for non-metastatic, non melanoma skin cancer.
20. Subjects who cannot perform spirometry manuevers or tolerate body plethysmography.
21. Subjects with known hypersensitivity to Symbicort, its monocomponents (budesonide or formoterol), or its excipients.

Location

Research Site

Charlotte, NC, United States, 28207

Location

Research Site

Spartanburg, SC, United States, 29303

Location

Research Site

Hartford, CT, United States, 06105

Location

Research Site

Boston, MA, United States, 02115

Location

Research Site

Philadelphia, PA, United States, 19140

Arms	Assigned Interventions
Active Comparator: Symbicort pressurized Metered Dose Inhaler (pMDI) Symbicort pressurized Metered Dose Inhaler (pMDI)	Drug: Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg Inhalation aerosol Subjects will receive a single dose (2 inhalations) of Symbicort pMDI 160/4.5 μg (2 inhalations; total dosage 320/9.0 μg) or placebo (with a spacer) in a cross-over design (a total of 2 doses of Symbicort and 2 doses of placebo over the duration of the study), and assessments will be made before and after dosing at specified timepoints
Placebo Comparator: Placebo of reference drug Placebo of reference drug	Drug: Matching Placebo pMDI 160/4.5 μg Placebo will be given according at the same dose and schedule as the active comparator – cross-over design.

Arms

Assigned Interventions

Active Comparator: Symbicort pressurized Metered Dose Inhaler (pMDI)
Symbicort pressurized Metered Dose Inhaler (pMDI)

Drug: Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg Inhalation aerosol
Subjects will receive a single dose (2 inhalations) of Symbicort pMDI 160/4.5 μg (2 inhalations; total dosage 320/9.0 μg) or placebo (with a spacer) in a cross-over design (a total of 2 doses of Symbicort and 2 doses of placebo over the duration of the study), and assessments will be made before and after dosing at specified timepoints

Placebo Comparator: Placebo of reference drug
Placebo of reference drug

Drug: Matching Placebo pMDI 160/4.5 μg
Placebo will be given according at the same dose and schedule as the active comparator – cross-over design.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Trial Results Summaries