Recruiting
Phase 2

Symbicort & Advair

Sponsor:

University of British Columbia

Code:

NCT02833480

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Fluticasone group

Budesonide group

Formoterol group

Study Details

Brief summary:

This study will evaluate the effects of budesonide (using Symbicort which is budesonide and formoterol) and fluticasone (using Advair which is fluticasone and salmeterol) on the airway microorganisms of patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). This is a randomized, parallel group, two-centered clinical trial study to evaluate the effects of a 12 week treatment with Symbicort 400 mcg BID and Advair 250 mcg BID (via Diskus) on airway microbiota in patients with moderate-to-severe COPD. The control arm of this study will be Oxeze 12 ug BID.

Conditions

Chronic Obstructive Pulmonary Disease

Study ID

NCT02833480

Start date

Feb, 2015

Status verified date

Mar, 2020

Completion date

Jun, 2021

Anticipated

Primary completion date

Jan, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures.
  • History of moderate to very severe COPD with a post-bronchodilator forced expiratory volume/forced vital capacity (FEV1/FVC) <0.70 and a post-bronchodilator FEV1>20% and ≤80% of predicted normal value at screening.
  • Current smoker or ex-smoker with a tobacco history of ≥10 pack-years (1 pack year= 20 cigarettes smoked per day for 1 year).

Exclusion Criteria:

  • Clinically important pulmonary disease other than COPD (e.g. active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, and primary ciliary dyskinesia) and/ or radiological findings suggestive of a respiratory disease other than COPD that is contributing to the subject's respiratory symptoms.
  • Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:

1. Affect the safety of the subject throughout the study
2. Influence the findings of the study or their interpretation
3. Impede the subject's ability to complete the entire duration of study Subjects who have epilepsy must be on a stable dose of medication for 30 days prior to Visit 4.
  • Unstable ischemic heart disease, or uncontrolled arrhythmia, cardiomyopathy, heart failure, and renal failure, or uncontrolled hypertension as defined by the Investigator, or any other relevant cardiovascular disorder as judged by the Investigator
  • Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 8 weeks prior to enrolment (Visit 1), based on last dose of steroids or last date of hospitalization whatever occurred later.
  • Acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 2 weeks prior to enrolment (Visit 1).
  • Pneumonia within 8 weeks prior to enrolment (Visit 1), based on the last day of antibiotic treatment or hospitalization date, whatever occurred later.
  • Pregnant, breastfeeding, or lactating women.
  • Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which, in the opinion of the Investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to complete entire duration of the study.
  • Use of immunosuppressive medication, including rectal corticosteroids, high potency topical corticosteroids and systemic steroids within 28 days prior to randomization.
  • Receipt of blood products within 30 days prior to enrollment (Visit 1).
  • Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1.
  • History of alcohol or drug abuse within the past year, which may compromise the study data interpretation as judged by Investigator or Study Physician.
  • Subjects who in the opinion of the investigator or qualified designee have evidence of active tuberculosis (TB), either treated or untreated.
  • Scheduled in-patient hospitalization or surgical procedure during the course of the study.
  • Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA, http://www.ginasthma.org/) guidelines or other accepted guidelines. Subjects with a past medical history of asthma (e.g. childhood or adolescence) may be included.
  • The male partner of someone who may become pregnant during the course of the study

Study Design

Enrollment

69 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fluticasone group

Advair (fluticasone) 250 mcg to be administered twice daily via Diskus for 12 weeks

experimental: Budesonide group

Symbicort (budesonide) 400 mcg to be administered twice daily via Turbuhaler for 12 weeks

active comparator: Formoterol group

Oxeze (formoterol) 12 microg to be administered twice daily via Turbuhaler for 12 weeks

Interventions

Fluticasone group

Budesonide group

Formoterol group

Primary outcome measure

  • Change in total bacterial population in the bronchoalveolar lavage fluid [ Time Frame: 12 weeks ]
  • Change in bacterial diversity using Shannon Index based on 16S sequencing. [ Time Frame: 12 weeks ]

Central Contacts and Locations

Locations

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z1Y6

Contacts

Principal Investigator:

Don Sin, MD

BC Cancer Agency

Recruiting

Vancouver, British Columbia, Canada

Contacts

Principal Investigator:

Stephen Lam, MD

More Information

Sponsor

University of British Columbia

Last update posted

Mar 30, 2020

Last verified

Mar, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2020-03-30.