ACTRN12607000379415TerminatedPhase 4
In bronchiectatic patients susceptible to airway narrowing after inhaling dry powder mannitol is a single dose of sodium cromoglycate or eformoterol more effective than placebo in preventing airway narrowing
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 25
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Prevention
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (—)
- Sex
- All
Inclusion Criteria
- •Subjects must: 1) Have given written informed consent to participate in this study, 2) Have symptomatic (i.e. daily production of sputum) non-cystic fibrosis (CF) bronchiectasis, confirmed by high resolution computed tomography (HRCT), 3) Be a non smoker, 5) Be able to perform reproducible spirometry, 4) Have an FEV1 1.2 Litres, 5) Be in a stable clinical condition at the time of, and for a period of 14 days prior to, recruitment into the study, 6) Have a positive response to inhaled mannitol, as measured by a fall in FEV1 of 15% after < 315mg of mannitol on Visit 1
Exclusion Criteria
- •Subjects must not: 1) Have bronchiectasis as a consequence of cystic fibrosis or focal endobronchial lesion, 2) Be considered terminally ill” or listed for lung transplantation, 3) Have had a significant episode of haemoptysis (>60 mL) in the previous six months, 4) Have had an exacerbation for which they have been prescribed intravenous antibiotics in the 4 weeks prior to study entry, 5) Have a smoking history of >20 pack years or have smoked more than one cigarette a week within the previous three months, 6) Have had a myocardial infarction in the three months prior to enrolment, 7) Have had a cerebral vascular accident in the three months prior to enrolment, 8) Have had major ocular surgery in the three months prior to enrolment, 9) Have had major abdominal, chest or brain surgery in the three months prior to enrolment, 10) Have a known cerebral, aortic or abdominal aneurysm, 11) Have active tuberculosis, 12) Have active malignancy including melanoma (other skin carcinomas and remissions exempted), 13) Be breast feeding or pregnant, or plan to become pregnant while in the study, 14) Be using an unreliable form of contraception (female subjects at risk of pregnancy only), 15) Be participating in another investigative drug study, parallel to, or within 4 weeks of study entry, 16) Have a known intolerance to mannitol or ß-agonists, 17) Have uncontrolled hypertension – systolic BP > 190 and/or diastolic BP > 100, 18) Have resting oximetry of less than 90%, 19) Have a condition or be in a situation which in the Investigator’s opinion may put the subject at significant risk, may confound results or may interfere significantly with the patient’s participation in the study.
Investigators
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