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BronchiectasisPhase 3NCT00669331

Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis

A Phase 3 study testing Inhaled mannitol in people with Bronchiectasis, run by Syntara at 83 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Forced expiratory volume in one second (FEV1) in a short-term non-CF bronchiectasis study and has been shown to be… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Bronchiectasis
What is being tested?
Inhaled mannitol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
485 participants
Where
83 sitesin 9 countries
Study dates
Nov 2009to Jan 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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)

Who cannot join

  • 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
Show all 25Show fewer
  • 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)

Trial locations and contacts

83 sites in 9 countries.

83 sites in 9 countries

United Kingdom24 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 22N

  • Belfast City Hospital

    Belfast, BT9 7AB

  • Birmingam Queen Elizabeth Hospital

    Birmingham, West Midlands, B15 2TH

  • Llandough Hospital

    Cardiff, Vale of Glamorgan, CF64 2XX

  • West Wales General Hospital

    Carmarthen, Carmarthenshire, SA31 2AF

  • Ashford & St Peters Hospital

    Chertsey, Surrey, KT16 0PZ

  • Castle Hill Hospital

    Cottingham, East Yorkshire, HU16 5JQ

  • Royal Derby Hospital

    Derby, Derbyshire, DE22 3NE

  • Royal Devon and Exeter Hospital

    Exeter, Devon, EX2 5DW

  • Churchill Hospital

    Headington, Oxfordshire, OX3 7LJ

  • Glenfield Hospital

    Leicester, Leicestershire, LE3 9QP

  • University Hospital Aintree

    Liverpool, L9 7AL

  • Royal Brompton Hospital

    London, SW3 6NP

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • North Tyneside General Hospital

    North Shields, NE29 8NH

  • Nottingham City Hospital

    Nottingham, Nottinghamshire, NG5 1PB

  • Sheffield Northern General Hospital

    Sheffield, South Yorkshire, S5 7AU

  • Royal Shrewsbury Hospital

    Shrewsbury, Shropshire, SY3 8XQ

  • Southampton General Hospital

    Southampton, SO16 6YD

  • Stafford Hospital

    Stafford, Staffordshire, ST16 3SA

  • University Hospital of North Tees

    Stockton, Teeside, TS19 8PE

  • Torbay Hospital

    Torquay, Devon, TQ2 7AA

  • Wolverhampton New Cross Hospital

    Wolverhampton, West Midlands, WV10 0QP

  • Wrexham Maelor Hospital

    Wrexham, LL13 7TD

Other trials in United Kingdom

United States19 sites

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • The University of Chicago Hospitals

    Chicago, Illinois, 60637

  • National Jewish Medical and Research Center

    Denver, Colorado, 80206

  • University of Connecticut Health Center, Pulmonary Division

    Farmington, Connecticut, 06030-1321

  • University of Miami

    Miami, Florida, 33136

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Research Associates of New York

    New York, New York, 10028

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • The Oregon Clinic, PC/Pulmonary Division

    Portland, Oregon, 97220

  • Pulmonary Associates of Richmond, Inc

    Richmond, Virginia, 23225

  • Allergy and Critical Care Medicine Pulmonary Clinical Research Unit

    Rochester, Minnesota, 55905

  • Alamo Clinical Research Associates

    San Antonio, Texas, 78212

  • Chest Medicine Clinical Services, LLC

    Skokie, Illinois, 60076

  • South Carolina Pharmaceutical Research

    Spartanburg, South Carolina, 29303

  • Pulmonary and Allergy Associates

    Summit, New Jersey, 07901

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Florida Pulmonary Research

    Winter Park, Florida, 32789

Other trials in United States

Argentina14 sites

  • Hospital Interzonal General de Agudos "Dr Jose Penna"

    Bahia Bianca, Provinica de Buenos Aires, B8001DDU

  • Instituto Argentino de Investigación Neurológica

    Buenos Aires, Buenos Aires F.D., C1015ABR

  • Centro Médico Dra. De Salvo

    Buenos Aires, CP1426ABO

  • Atención Integral en Reumatología (AIR)

    Buenos Aires, CP1426

  • Hospital Privado - Centro Medico de Cordoba

    Córdoba, Córdoba Province, X5016KEH

  • Centro Privado de Medicina Respiratoria

    Entre Ríos, Paraná Entre Ríos, E3100BHK

  • Hospital Zonal Especializado en Agudos y Cronicos "Dr Antonio A. Cetrangolo

    Florida Partido de Vicente López, Buenos Aires, B1602DOH

  • Corporacion medica de General San Martin

    Matheu, San Martin Provincia de Buenos Aires, B1650CSQ

  • Insares

    Mendoza, Mendoza Province, M5500CCG

  • Centro Respiratorio Quilmes

    Quilmes, Buenos Aires, B1878FNR

  • Clinica del Torax

    Rosario, Santa Fe Province, S2000DBS

  • Instituto Cardiovascular de Rosario

    Rosario, Santa Fe Province, S2000DSR

  • Sanatorio Parque

    Rosario, Santa Fe Province, S2000KZD

  • Investigaciones en Patologias Respiratorias

    San Miguel de Tucumán, Tucumán Province, T4000IAR

Other trials in Argentina

Australia10 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Repatriation General Hospital

    Daws Park, South Australia, 5041

  • St Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Western Hospital

    Footscray, Victoria, 3011

  • The Rooms of Dr C Steinfort

    Geelong, Victoria, 3220

  • Woolcock Institute of Medical Research

    Glebe, New South Wales, 2037

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Royal Melbourne Hospital

    Melbourne, Victoria, 3050

  • The Queen Elizabeth Hospital

    Woodville, South Australia, 5011

Other trials in Australia

Germany4 sites

  • Lungen und Bronchialheikunde

    Bonn, North Rhine-Westphalia, 53123

  • IKF Pneumologie GmbH and Co KG

    Frankfurt am Main, Hesse, 60596

  • Medizinische Hochschule Hannover Klinik für Pneumologie

    Hanover, Lower Saxony, 30625

  • Pneumologisch Studienzentrum

    Leipzig, Saxony, 4357

Other trials in Germany

Belgium3 sites

  • ULB Hopital Erasme - Department of Pneumology

    Brussels, Brussels Capital, B-1070

  • Cliniques Universitaires St. Luc (UCL) - Department of Pulmonology

    Brussels, Brussels Capital, B-1200

  • UZ Leuven (University Hospital Leuven) - Depatment of Pulmonary Medicine

    Leuven, Leuven, B-3000

Other trials in Belgium

Chile3 sites

  • Pontificia Universidad Catolica de Chile

    Santiago, Santiago Metropolitan

  • Universidad de Chile

    Santiago, Santiago Metropolitan

  • Hospital Regional de Talca

    Talca, Talca, 1990

Other trials in Chile

Netherlands3 sites

  • Medisch Centrum Alkmaar - Department of Pulmonary Medicine

    Alkmaar, Alkmaar AM, 1800

  • Atrium MC -Department of Pulmonary Diseases

    Heerlen, Heerlen, 6419

  • Medisch Centrum Leeuwarden (MCL) - Department of Pulmonology

    Leeuwarden, Leeuwarden AD, 8934

Other trials in Netherlands

New Zealand3 sites

  • Middlemore Hospital

    Auckland, Auckland, 1640

  • Green Lane Clinical Centre

    Greenlane, Auckland, 1051

  • Waikato Hospital

    Hamilton, 3240

Other trials in New Zealand

About this study

Official title: : A Phase III Multicenter, Randomized, Parallel Group, Controlled, Double Blind Study to Investigate the Safety and Efficacy of Inhaled Mannitol Over 12 Months in the Treatment of Bronchiectasis.

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 Forced expiratory volume in one second (FEV1) in a short-term non-CF bronchiectasis study and has been shown to be detrimental after 6 months therapy in non CF bronchiectasis, moreover it has no proven effect on mucociliary clearance. Hypertonic saline has been shown to have a comparable mode of action to inhaled mannitol, but has yet to be examined as a long term treatment option in bronchiectasis.

The purpose of this study is to examine the efficacy and safety of 52 weeks treatment with inhaled mannitol in subjects with non-cystic fibrosis bronchiectasis. Previous studies with inhaled mannitol have demonstrated improvement in mucociliary clearance; mucus rehydration; improvement in quality of life and respiratory symptoms in patients with bronchiectasis and pulmonary function in cystic fibrosis. The results of this current study in combination with a recently completed 3 month study seek to confirm these early findings and to extend the evidence to support its use as a mucoactive therapy in subjects with bronchiectasis.

Read more

We hypothesize that mannitol will improve the overall health and hygiene of the lung through regular and effective clearing of the mucus load. As a consequence of the reduction in mucus load and inflammatory process, the frequency of bronchiectasis related pulmonary exacerbations and the need for exacerbation related antibiotic treatment should fall. Days in hospital and community health care costs are expected to change in line with improvements in respiratory health.

Finally, we plan to demonstrate that inhaled mannitol is safe and well tolerated over a 52 week period. We will test these hypotheses using 400 mg mannitol twice daily (BD) against control.

Conditions
Bronchiectasis
Being tested
Inhaled mannitol, Matched control
Keywords
randomized clinical trial, mannitol, mucoactive
Medical subject headings
Bronchiectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inhaled mannitolDrug

    400mg dose of Mannitol BD (twice a day) for 52 weeks

  • Matched controlDrug

    50mg dose of Mannitol BD (twice a day) for 52 weeks

Study groups in NCT00669331
Study groupRoleWhat they receive
MannitolExperimentalInhaled mannitol 400mg
Receives: Drug: Inhaled mannitol
ControlPlacebo comparatorMatched control - inhaled mannitol 50mg
Receives: Drug: Matched control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Graded Pulmonary Exacerbations

    A graded pulmonary exacerbation was defined as a worsening in signs and symptoms requiring a change in treatment (Center for Drug Evaluation and Research (CDER), 2007). Grade I was required 3 main signs and symptoms, Grade II 2 main signs and symptoms and Grade III 1 main and one or more minor signs and symptoms. Main signs and symptoms were increased cough, sputum volume or sputum purulence. Minor were upper respiratory tract infection, fever, increased wheezing, increased dyspnea, increase in respiratory rate, increase in cardiac frequency of >20%, and increased malaise, fatigue or lethargy. Rate is defined as the number of all GPE events observed in one treatment year

    Measured: 52 weeks

Secondary outcomes (14)

  1. Quality of Life as Measured by the St. Georges Respiratory Questionnaire (SGRQ) Total Score

    The SGRQ was collected at baseline, week 6, week 16, week 28, week 40 and week 52. Change in total score was calculated from baseline. Total scores are a weighted sum across all questions. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. Higher scores indicate lower quality of life. Outcome data table gives the raw mean total score at each visit.

    Measured: 52 weeks

  2. Antibiotic Use Prescribed for Treated Pulmonary Exacerbations

    Rate of antibiotic treated graded pulmonary exacerbations, using the same definition of a graded pulmonary exacerbation as the primary endpoint. A graded pulmonary exacerbation was considered to be anti-biotic treated if use of oral, IV or inhaled antibiotic use was recorded related to the GPE event.

    Measured: 52 weeks

  3. Time to First Graded Exacerbation

    Time to first graded exacerbation is defined as the duration (in months) from the randomisation date to the start of the first reported graded PE during the on-treatment period. Patients without reported graded PE event will be censored at the last participation.

    Measured: 52 weeks

  4. Duration of Graded Exacerbations

    Duration of graded exacerbations is defined as the number of days with graded PE within one treatment year. Mean days estimated via negative binomial model with treatment, region and baseline pulmonary exacerbation rate as predictors, with log of follow-up time as the offset variable

    Measured: 52 weeks

  5. Sputum Volume

    24 hour sputum weight, measured at baseline, week 6, week 16, week 28, week 40, week 52

    Measured: 52 weeks

  6. Daytime Sleepiness Scores

    Epworth Sleepiness Scale (ESS) score was calculated as the sum of scores for each of eight individual questions, such that a total score of zero represents no daytime sleepiness, and a total score of 24 represents the maximum degree of daytime sleepiness. Measured at baseline, 6 weeks, 16 weeks, 28 weeks, 40 weeks, 52 weeks

    Measured: 52 weeks

  7. Lung Function - Change in FEV1 (Forced Expiratory Volume in One Second)

    Measured: 52 weeks

  8. Lung Function - Change in FVC (Forced Vital Capacity)

    Measured: 52 weeks

  9. Lung Function - Change in FEV1/FVC

    FEV1 expressed as a ratio of FVC. Endpoint is expressed as a percentage ie FEV1/FVC*100

    Measured: 52 weeks

  10. Lung Function - Change in FEF25-75 (Forced Expiratory Flow Rate Averaged Over 25th -75th Percentile of FVC)

    Measured: 52 weeks

  11. Safety Profile - Sputum Microbiology

    sputum microbiology assessed as the presence of abnormal flora in sputum sample taken at any post baseline visit

    Measured: 52 weeks

  12. Safety Profile - Clinical Chemistry

    Clinical chemistry was assessed as clinically significant abnormal liver function test and clinically significant abnormal urea/electrolyte test at any point post baseline.

    Measured: 52 weeks

  13. Safety Profile - Hematology

    hematology assessed as clinically significant abnormal FBC (Full Blood count) at any point post baseline.

    Measured: 52 weeks

  14. • (Exploratory) Number of Hospitalizations Due to Pulmonary Exacerbations

    Mean rate of hospitalisations (number/year) summarised and analysed to take account of differing follow-up times.

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2008 (estimated)
  2. Study startNov 2009
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
485 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00669331
Sponsor's protocol ID
DPM-B-305
Status last verified
Mar 2016
First submitted
28 Apr 2008
Last updated
29 Apr 2016
Data monitoring committee
Yes

Publications

  • Daviskas E, Anderson SD, Eberl S, Chan HK, Bautovich G. Inhalation of dry powder mannitol improves clearance of mucus in patients with bronchiectasis. Am J Respir Crit Care Med. 1999 Jun;159(6):1843-8. doi: 10.1164/ajrccm.159.6.9809074.

    PubMed 10351929

  • Daviskas E, Anderson SD, Eberl S, Young IH. Effect of increasing doses of mannitol on mucus clearance in patients with bronchiectasis. Eur Respir J. 2008 Apr;31(4):765-72. doi: 10.1183/09031936.00119707. Epub 2007 Dec 5.

    PubMed 18057051

  • Daviskas E, Anderson SD, Young IH. Inhaled mannitol changes the sputum properties in asthmatics with mucus hypersecretion. Respirology. 2007 Sep;12(5):683-91. doi: 10.1111/j.1440-1843.2007.01107.x.

    PubMed 17875056

  • Daviskas E, Anderson SD. Hyperosmolar agents and clearance of mucus in the diseased airway. J Aerosol Med. 2006 Spring;19(1):100-9. doi: 10.1089/jam.2006.19.100.

    PubMed 16551221

  • Daviskas E, Anderson SD, Gomes K, Briffa P, Cochrane B, Chan HK, Young IH, Rubin BK. Inhaled mannitol for the treatment of mucociliary dysfunction in patients with bronchiectasis: effect on lung function, health status and sputum. Respirology. 2005 Jan;10(1):46-56. doi: 10.1111/j.1440-1843.2005.00659.x.

    PubMed 15691238

  • Daviskas E, Robinson M, Anderson SD, Bye PT. Osmotic stimuli increase clearance of mucus in patients with mucociliary dysfunction. J Aerosol Med. 2002 Fall;15(3):331-41. doi: 10.1089/089426802760292681.

    PubMed 12396422

  • Daviskas E, Anderson SD, Eberl S, Chan HK, Young IH. The 24-h effect of mannitol on the clearance of mucus in patients with bronchiectasis. Chest. 2001 Feb;119(2):414-21. doi: 10.1378/chest.119.2.414.

    PubMed 11171717

  • Bilton D, Tino G, Barker AF, Chambers DC, De Soyza A, Dupont LJ, O'Dochartaigh C, van Haren EH, Vidal LO, Welte T, Fox HG, Wu J, Charlton B; B-305 Study Investigators. Inhaled mannitol for non-cystic fibrosis bronchiectasis: a randomised, controlled trial. Thorax. 2014 Dec;69(12):1073-9. doi: 10.1136/thoraxjnl-2014-205587. Epub 2014 Sep 21.

    PubMed 25246664

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inhaled mannitol in people with Bronchiectasis, run by Syntara at 83 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United Kingdom, United States, Argentina, Australia, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Graded Pulmonary Exacerbations (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00669331, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016.

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