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Phase 4 N=51 Randomized Double-blind Treatment

Phase IV O2 Consumption Study in COPD Patients.

Chronic Obstructive Pulmonary Disease (COPD)

Enrolled (actual)
51
Serious AEs
1.0%
Results posted
Jul 2018
Primary outcome: Primary: Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Oxygen Consumption (VO2; Obtained Via a Metabolic Cart) — 11.366; 1.252 mL/min — p=0.007

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg Inhalation aerosol (Drug); Matching Placebo pMDI 160/4.5 μg (Drug)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
AstraZeneca
Primary completion
Aug 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Oxygen Consumption (VO2; Obtained Via a Metabolic Cart)
11.366; 1.252 0.007 sig
SECONDARY
Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Oxygen Pulse (Defined as VO2/Heart Rate [HR]; VO2 is Obtained Via a Metabolic Cart; Used as a Surrogate for Stroke Volume)
0.256; 0.168 0.111
SECONDARY
Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Gas Exchange Parameter HR
-2.481; -2.831 0.609
SECONDARY
Change From Pre-dose (Visit 2)to Post-dose (Visit 5) Assessment in Spirometry.
0.187; -0.004; 0.259; -0.052; 0.256; -0.024 <0.001 sig
SECONDARY
Change in Vt/Ti
26.533; 3.217 0.021 sig
SECONDARY
Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in the Modified Borg Scale for Dyspnea
-0.452; -0.248 0.106
SECONDARY
Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Gas Exchange Parameter VCO2
5.994; -4.251 0.011 sig
SECONDARY
Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Gas Exchange Parameter SaO2
0.422; 0.181 0.333
SECONDARY
Change in RR
-0.193; -0.430 0.484
SECONDARY
Change in Ti/Ttot
0.012; -0.004 0.113
SECONDARY
Change in Vt
71.904; 14.281 <0.001 sig
SECONDARY
Change in Ve
838.232; -23.924 <0.001 sig
SECONDARY
Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Spirometry.
0.017; -0.002 0.007 sig

Summary

A Phase IV study evaluating changes in oxygen consumption and cardiac function in Subjects with Chronic obstructive pulmonary disease (COPD) with resting hyperinflation after administration of Symbicort pMDI 160/4.5 μg.

Eligibility Criteria

Inclusion Criteria

  • Signing of the informed consent form (ICF) prior to any study specific procedures, including withholding of medications.
  • Male or female, aged 40 to 80 years, inclusive, at Screening (Visit 1).
  • 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 10% after the administration of 1 inhalation of open-label Symbicort pMDI administered with a spacer at Screening (Visit 1).
  • Has a cigarette smoking history of more than 10 pack-years (number of cigarettes smoked per day × number of years smoked)/20).
  • Be able to understand and comply with study requirements, as judged by the Investigator.

Exclusion Criteria

  • 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).
  • Previous enrollment or randomization in this study.
  • Participation in another clinical study with an investigational product (IP) during the last 30 days prior to Screening (Visit 1).
  • 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.
  • Subjects who are taking uLABAs (indacaterol, vilanterol) or uLABA-containing products.
  • Subjects who are taking PDE-4 inhibitors (roflumilast).
  • Subjects who are taking oral corticosteroids on a chronic, regular basis.
  • Subjects using daytime oxygen therapy.
  • Subjects who are currently pregnant (confirmed with positive pregnancy test) or breast feeding.
  • History of respiratory tract infection (including the upper respiratory tract) and/or pulmonary exacerbation within 6 weeks prior to Screening (Visit 1).
  • 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.
  • History or current diagnosis of asthma and/or alpha 1 anti-trypsin deficiency.
  • Known active tuberculosis.
  • History of interstitial lung or massive pulmonary thromboembolic disease.
  • History of bronchiectasis secondary to respiratory diseases other than COPD (eg, cystic fibrosis, Kartagener's syndrome, etc).
  • 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.
  • 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.
  • Previous or current history of lung cancer.
  • History of cancer (within 5 years prior to Visit 1), except for non-metastatic, non melanoma skin cancer.
  • Subjects who cannot perform spirometry manuevers or tolerate body plethysmography.
  • Subjects with known hypersensitivity to Symbicort, its monocomponents (budesonide or formoterol), or its excipients.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02533505). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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