The effect on bacteria of breathing in (through an inhaler) a drug which reduces swelling (a steroid) in severe COPD (chronic obstructive pulmonary disease) patients with associated widening of the air tubes (bronchiectasis)

Not Applicable

• Conditions: Chronic obstructive pulmonary disease (COPD) with widening of the air tubes (bronchiectasis); Respiratory; Chronic Obstructive Pulmonary Disease (COPD) with associated bronchiectasis

• Registration Number: ISRCTN15449782
• Lead Sponsor: The University of Edinburgh & Lothian Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-25
• Last Update Posted: 22 April 2024
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Subjects eligible for enrolment in the study must meet all of the following criteria:
1. Informed Consent: A signed and dated written informed consent prior to study participation.
2. Type of subject: Outpatient.
3. Age: Subjects 40 years of age or older at screening visit.
4. Gender: Male or female subjects.
5. COPD Diagnosis: An established clinical history of COPD as documented in medical notes in accordance with the definition by the American Thoracic Society/European Respiratory Society. COPD-Bronchiectasiscoexistence: smoking history of greater than 10 pack year, with a post bronchodilator FEV1/FVC ratio <0.7 with coexistent bronchiectasis on a high-resolution CT Chest (increased broncho-arterial ratio in two or more lobes of the lung). CT scans would have been done prior to recruitment as a part of usual clinical pathway.
5.1 Two or more exacerbations in the last 1-year (requiring antibiotics and/steroids) or one or more hospitalisation in accordance with GOLD D (2017) classification (high risk more symptom COPD patients) but clinically stable during screening period.
5.2 Clinically stable is defined as not requiring antibiotics and or steroid 4 weeks prior to study entry. This will be checked during the randomisation visit from patient history and documented by the research nurses.
6. Smoking history: Current or former cigarette smokers (cigarettes or rolled tobacco) with a history of cigarette smoking of >10 pack-years at screening (visit 1) [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)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history.

Exclusion Criteria

1. Pregnancy: Women who are pregnant or breast feeding or are planning on becoming pregnant during the study.
2. Asthma: Subjects with a current/ concurrent diagnosis of asthma.
3. a1-antitrypsin deficiency: Subjects with known a1-antitrypsin deficiency as the underlying cause of COPD.
4. Other respiratory disorders: Subjects with active tuberculosis, active lung cancer, sarcoidosis, lung fibrosis, pulmonary hypertension, or other interstitial lung diseases.
5. Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening.
6. Risk Factors for Pneumonia: immune suppression (e.g. HIV, Lupus) or other risk factors for pneumonia, when patients are on long standing immunosuppressive drugs or have neuromuscular conditions affecting control of the upper airway, such as Parkinson’s disease, Motor Neuron Disease or Myasthenia Gravis.
7. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable). In addition, any subject that experiences pneumonia and/or moderate or severe COPD exacerbation during the washout period will be excluded.
8. Other Respiratory tract infections that have not resolved at least 7 days prior to screening including COVID19 infections
9. Other diseases/abnormalities: Subjects with historical or current evidence of any of the following clinically significant abnormalities that are uncontrolled:
9.1. cardiovascular
9.2. neurological
9.3. psychiatric (including documented psychiatric reactions or hypersensitivity to oral steroids)
9.4. renal
9.5. hepatic
9.6. immunological
9.7. gastrointestinal
9.8. urogenital (e.g. significant prostatic hyperplasia/bladder outflow obstruction)
9.9. nervous system
9.10. musculoskeletal (including known significant osteoporosis)
9.11. skin
9.12. sensory
9.13. endocrine (including uncontrolled Type 1 or 2 diabetes or thyroid disease)
9.14. ocular (e.g. significant narrow angle glaucoma)
9.15. haematological
10. Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, oesophageal or gastric varices or persistent jaundice.
11. Unstable or life-threatening cardiac disease
12. Abnormal and clinically significant 12-Lead ECG finding
13. Other Contraindications: A history of allergy or hypersensitivity to any oral steroid or corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, uncontrolled symptomatic prostatic hypertrophy or bladder neck obstruction that, in the opinion of the Investigator contraindicates study participation.
14. Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, prostrate carcinoma, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5year waiting period if the subject has been considered cured by treatment.
15. Oxygen therapy: Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3L/min (Oxygen use up to 3L/min flow is not exclusionary.)
16. Medication prior to spirometry: Subjects who are medically unable to withhold their salbutamol for the 4-hour period required prior to spirometry testing at each study visit.
17. Pulmonary rehabilitation: Subjects who have participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified