Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Long-term inhaled dry powder mannitol improves lung function in CF

16.12.2011
Adding inhaled dry powder mannitol to standard therapy for cystic fibrosis produced sustained improvement in lung function for up to 52 weeks, according to a new study. Along with the treatment's efficacy and good safety profile, the convenience and ease of administration of mannitol treatment may improve adherence with therapy in these patients.

In the double-blind study, which was supported by Pharmaxis Limited, 318 patients were randomized to treatment with 400 mg bid inhaled mannitol or 50 mg bid inhaled mannitol (control group) for 26 weeks, followed by an additional 26 weeks of open-label active treatment.

A 50 mg dose was chosen as the control because it was felt it would not be clinically effective, based on an earlier dose escalation study. Mannitol was given on top of a background of typical concomitant therapy such as recombinant human deoxyribonuclease and inhaled antibiotics.

The findings were published online ahead of print publication in the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine.

"Patients in the treatment group showed a 106.5 mL mean improvement in forced expiratory volume in one second (FEV1), an 8.22 percent improvement from baseline, compared with a 52.4 mL improvement (4.47 percent) in the control group," said lead author Moira L. Aitken, MD, professor of pulmonary and critical care medicine at the University of Washington Medical Center. "Forced vital capacity increased 136.3 mL in the treatment group, compared with 65.0 mL in the control group. Treated patients also experienced fewer pulmonary exacerbations than controls."

The difference in absolute FEV1 between the study and control groups approached statistical significance (p=0.059), while the difference in relative change from baseline FEV1 between groups reached significance (p=0.029). Improvements in FEV1 were maintained in the treatment group during the 26-week open-label extension phase of the study. In the control group, mean FEV1 improved 84.0 mL (6.3 percent) from baseline during the open-label phase.

Patients in the treatment and control groups experienced similar rates of adverse events. Given a possible influence of mannitol on lung microbiology, qualitative sputum microbiology was performed for Staphylococcus aureus and Pseudomonas aeruginosa during the double-blind study period. No qualitative changes in microbiology results from baseline were observed in either group.

Compliance was good in both groups, with 85.2 percent of patients in the treatment group and 88.7 percent of controls using 60 percent or more of the drug dispensed.

Although the primary end point for the study, the difference in absolute FEV1 between the treatment and control groups, did not reach significance, this may have been due to use of a single baseline visit to establish baseline FEV1 values. When baseline FEV1 values were calculated as an average of FEV1 values over two baseline visits, as in prior clinical intervention studies, the overall increase in absolute FEV1 was significantly (p=0.0008) greater in the treatment group. The 50 mg dose of mannitol used in the control group may also have had some benefit, which limited the absolute difference between groups.

"In our patients with cystic fibrosis, treatment with inhaled mannitol resulted in sustained improvements in lung function over 12 months, with a favorable safety profile," concluded Dr. Aitken. "In addition, the dry-powder inhaler used to administer mannitol is small, portable, easy to use and doesn't require thorough cleaning and disinfection after each use, which may help patients better adhere to treatment. Our results support the use of inhaled mannitol for the daily management of cystic fibrosis."

About the American Journal of Respiratory Research and Critical Care Medicine:

With an impact factor of 10.191, the AJRRCM is a peer-reviewed journal published by the American Thoracic Society. It aims to publish the most innovative science and the highest quality reviews, practice guidelines and statements in the pulmonary, critical care and sleep-related fields.

Founded in 1905, the American Thoracic Society is the world's leading medical association dedicated to advancing pulmonary, critical care and sleep medicine. The Society's 15,000 members prevent and fight respiratory disease around the globe through research, education, patient care and advocacy.

Nathaniel Dunford | EurekAlert!
Further information:
http://www.thoracic.org

More articles from Health and Medicine:

nachricht Millions through license revenues
27.04.2017 | Rheinische Friedrich-Wilhelms-Universität Bonn

nachricht New High-Performance Center Translational Medical Engineering
26.04.2017 | Fraunhofer ITEM

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Making lightweight construction suitable for series production

More and more automobile companies are focusing on body parts made of carbon fiber reinforced plastics (CFRP). However, manufacturing and repair costs must be further reduced in order to make CFRP more economical in use. Together with the Volkswagen AG and five other partners in the project HolQueSt 3D, the Laser Zentrum Hannover e.V. (LZH) has developed laser processes for the automatic trimming, drilling and repair of three-dimensional components.

Automated manufacturing processes are the basis for ultimately establishing the series production of CFRP components. In the project HolQueSt 3D, the LZH has...

Im Focus: Wonder material? Novel nanotube structure strengthens thin films for flexible electronics

Reflecting the structure of composites found in nature and the ancient world, researchers at the University of Illinois at Urbana-Champaign have synthesized thin carbon nanotube (CNT) textiles that exhibit both high electrical conductivity and a level of toughness that is about fifty times higher than copper films, currently used in electronics.

"The structural robustness of thin metal films has significant importance for the reliable operation of smart skin and flexible electronics including...

Im Focus: Deep inside Galaxy M87

The nearby, giant radio galaxy M87 hosts a supermassive black hole (BH) and is well-known for its bright jet dominating the spectrum over ten orders of magnitude in frequency. Due to its proximity, jet prominence, and the large black hole mass, M87 is the best laboratory for investigating the formation, acceleration, and collimation of relativistic jets. A research team led by Silke Britzen from the Max Planck Institute for Radio Astronomy in Bonn, Germany, has found strong indication for turbulent processes connecting the accretion disk and the jet of that galaxy providing insights into the longstanding problem of the origin of astrophysical jets.

Supermassive black holes form some of the most enigmatic phenomena in astrophysics. Their enormous energy output is supposed to be generated by the...

Im Focus: A Quantum Low Pass for Photons

Physicists in Garching observe novel quantum effect that limits the number of emitted photons.

The probability to find a certain number of photons inside a laser pulse usually corresponds to a classical distribution of independent events, the so-called...

Im Focus: Microprocessors based on a layer of just three atoms

Microprocessors based on atomically thin materials hold the promise of the evolution of traditional processors as well as new applications in the field of flexible electronics. Now, a TU Wien research team led by Thomas Müller has made a breakthrough in this field as part of an ongoing research project.

Two-dimensional materials, or 2D materials for short, are extremely versatile, although – or often more precisely because – they are made up of just one or a...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Expert meeting “Health Business Connect” will connect international medical technology companies

20.04.2017 | Event News

Wenn der Computer das Gehirn austrickst

18.04.2017 | Event News

7th International Conference on Crystalline Silicon Photovoltaics in Freiburg on April 3-5, 2017

03.04.2017 | Event News

 
Latest News

Bare bones: Making bones transparent

27.04.2017 | Life Sciences

Study offers new theoretical approach to describing non-equilibrium phase transitions

27.04.2017 | Physics and Astronomy

From volcano's slope, NASA instrument looks sky high and to the future

27.04.2017 | Earth Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>