Status:
COMPLETED
Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis
Lead Sponsor:
Syntara
Conditions:
Bronchiectasis
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
No gold standard therapy exists for clearing mucus from the airways of patients with bronchiectasis. While rhDNase has a proven place in the treatment of cystic fibrosis (CF), it failed to improve For...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Have given written informed consent to participate in this study in accordance with local regulations
- Have documented evidence of confirmed diagnosis of (non-cystic fibrosis) bronchiectasis by computed tomography (CT), High resolution computed tomography (HRCT) or bronchogram
- Be aged 18 - 85 years inclusive, male and female
- Have FEV1 (Forced expiratory volume in one second) ≥ 40% and ≤85% predicted\* and ≥1.0L (\*according to NHANES III predicted tables) measured at Visit 0A (V0A)
- Clinician documented history of at least 2 pulmonary exacerbations, each requiring antibiotic therapy, in the last 12 months prior to Visit 0A (V0A) and a total of at least 4 in the last 2 years prior to Visit 0A
- Have a total SGRQ (St George's respiratory questionnaire) score of ≥30 at Visit 0B (V0B)
- Have a production of ≥10g of sputum at Visit 0B Have reported chronic sputum production of ≥1 tablespoon (15mL) per day on the majority of days in the 3 months prior to Visit 0A
- Be able to perform all the techniques necessary to measure lung function
- Have FEV1 ≥40% predicted\* and ≥1.0L (\*according to NHANES III 1999 predicted tables) measured at V0B (Baseline result prior to MTT (Mannitol Tolerance Test) administration)
- Exclusion Criteria
- Be investigators, site personnel directly affiliated with this study, or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
- Have bronchiectasis as a consequence of cystic fibrosis or focal endobronchial lesion or otherwise curable causes (e.g. foreign body aspiration)
- Be considered "terminally ill" or listed for transplantation
- Be using hypertonic saline in the 14 days prior to commencing Visit 0B or thereafter at any time during the study
- Have previously used inhaled mannitol (Bronchitol) for more than a day
- Have had a significant episode of hemoptysis (\>60 mL) in the previous 6 months
- Have had rescue antibiotics in the 4 weeks prior to V0B (chronic background antibiotic therapy accepted)
- Have smoked within the last 3 months and must not smoke during their participation in the study
- Have had a myocardial infarction in the three months prior to Visit 0A
- Have had a cerebral vascular accident in the three months prior to Visit 0A
- Have had major ocular surgery in the three months prior to Visit 0A
- Have had major abdominal, chest or brain surgery in the three months prior to Visit 0A
- Have a known cerebral, aortic or abdominal aneurysm
- Have actively treated Mycobacterium tuberculosis
- Have actively treated or unstable nontuberculous mycobacterial (NTM)infection or be under consideration for NTM treatment in the next 12 months
- Have unstable Allergic bronchopulmonary aspergillosis (ABPA) requiring steroid therapy (≤5mg dose oral steroids in stable ABPA accepted)
- Have end stage interstitial lung disease
- Have active malignancy including melanoma (other skin carcinomas exempted). Remissions from any malignancy ≥2 years also exempted
- Be breast feeding or pregnant, or plan to become pregnant while in the study
- Be using an unreliable form of contraception (female subjects at risk of pregnancy only)
- Be participating in another investigational drug study, parallel to, or within 4 weeks of Visit 0A
- Have a known intolerance to mannitol or β2-agonists
- Have uncontrolled hypertension - e.g. for adults: systolic blood pressure (BP) \> 190 and or diastolic BP \> 100
- Subject has a condition or is 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
- Have previously been screen failed for the study (exceptions - see section 3.3.2 Eligibility Criteria - Rescreening)
Exclusion
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
485 Patients enrolled
Trial Details
Trial ID
NCT00669331
Start Date
November 1 2009
End Date
January 1 2014
Last Update
April 29 2016
Active Locations (83)
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1
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
2
University of Connecticut Health Center, Pulmonary Division
Farmington, Connecticut, United States, 06030-1321
3
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
4
University of Miami
Miami, Florida, United States, 33136