A Study to Investigate the Differential Effects of Inhaled Symbicort and Advair on Lung Microbiota
DISARM
1 other identifier
interventional
69
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 chronic-obstructive-pulmonary-disease
Started Feb 2015
Longer than P75 for phase_2 chronic-obstructive-pulmonary-disease
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 26, 2016
CompletedFirst Posted
Study publicly available on registry
July 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedMarch 30, 2020
March 1, 2020
5.9 years
May 26, 2016
March 26, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Change in total bacterial population in the bronchoalveolar lavage fluid
12 weeks
Change in bacterial diversity using Shannon Index based on 16S sequencing.
12 weeks
Secondary Outcomes (9)
Change in bacterial membership using Beta-diversity
12 weeks
Characterization of bacteria Operational Taxonomic Unit
12 weeks
Change in total cell count in bronchoalveolar lavage fluid
12 weeks
Change in total neutrophil count in bronchoalveolar lavage fluid
12 weeks
Change in total lymphocyte count in bronchoalveolar lavage fluid
12 weeks
- +4 more secondary outcomes
Study Arms (3)
Fluticasone group
EXPERIMENTALAdvair (fluticasone) 250 mcg to be administered twice daily via Diskus for 12 weeks
Budesonide group
EXPERIMENTALSymbicort (budesonide) 400 mcg to be administered twice daily via Turbuhaler for 12 weeks
Formoterol group
ACTIVE COMPARATOROxeze (formoterol) 12 microg to be administered twice daily via Turbuhaler for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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:
- Affect the safety of the subject throughout the study
- Influence the findings of the study or their interpretation
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- AstraZenecacollaborator
Study Sites (2)
St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6, Canada
BC Cancer Agency
Vancouver, British Columbia, Canada
Related Publications (3)
Ho CG, Milne S, Li X, Yang CX, Leitao Filho FS, Cheung CY, Yang JSW, Hernandez Cordero AI, Yang CWT, Shaipanich T, van Eeden SF, Leung JM, Lam S, Sin DD. Airway Eosinophilia on Bronchoalveolar Lavage and the Risk of Exacerbations in COPD. Biomedicines. 2022 Jun 15;10(6):1412. doi: 10.3390/biomedicines10061412.
PMID: 35740433DERIVEDAkata K, Leung JM, Yamasaki K, Leitao Filho FS, Yang J, Xi Yang C, Takiguchi H, Shaipanich T, Sahin B, Whalen BA, Yang CWT, Sin DD, van Eeden SF. Altered Polarization and Impaired Phagocytic Activity of Lung Macrophages in People With Human Immunodeficiency Virus and Chronic Obstructive Pulmonary Disease. J Infect Dis. 2022 Mar 2;225(5):862-867. doi: 10.1093/infdis/jiab506.
PMID: 34610114DERIVEDLeitao Filho FS, Takiguchi H, Akata K, Ra SW, Moon JY, Kim HK, Cho Y, Yamasaki K, Milne S, Yang J, Yang CWT, Li X, Nislow C, van Eeden SF, Shaipanich T, Lam S, Leung JM, Sin DD. Effects of Inhaled Corticosteroid/Long-Acting beta2-Agonist Combination on the Airway Microbiome of Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Clinical Trial (DISARM). Am J Respir Crit Care Med. 2021 Nov 15;204(10):1143-1152. doi: 10.1164/rccm.202102-0289OC.
PMID: 34464242DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Don Sin, MD
St. Paul's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
May 26, 2016
First Posted
July 14, 2016
Study Start
February 1, 2015
Primary Completion
January 1, 2021
Study Completion
June 1, 2021
Last Updated
March 30, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share