The prevention of airway narrowing following dry powder mannitol inhalation in susceptible bronchiectatic patients

Phase 4

• Conditions: Prevention of airway narrowing in bronchiectatic patients following inhalation of dry powder mannitol; Respiratory - Asthma

• Registration Number: ACTRN12607000379415
• Lead Sponsor: Sydney South West Area Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The dose of mannitol required to induce a 15% fall in forced expired volume in one second (FEV1)[At Visit 1, and for Visits 2-4: 15 minutes after the administration of placebo, sodium cromoglycate or eformoterol];The response dose ratio (final percentage fall in FEV1 divided by the dose of mannitol administered)[At Visit 1, and for Visits 2-4: 15 minutes after the administration of placebo, sodium cromoglycate or eformoterol]

Secondary Outcome Measures

Name	Time	Method
Arterial blood oxygen saturation as estimated by pulse oximetry[At Visits 1-4, measured pre- and post-mannitol challenge and following recovery after the administration of salbutamol, if required.];Evidence of atopy as determined by skin prick testing using common airborne allergens[At Visit 1]