The researchers found that the 2-year airflow decline-free survival was 32.8 and 41.3% with azithromycin and placebo, respectively (unadjusted hazard ratio, 1.3).
Results showed that the ivacaftor/tezacaftor group reached the primary endpoint with a mean absolute improvement in ppFEV1 of 4% points from baseline vs. placebo (P<0.0001).
The researchers found that new antibiotic treatment was associated with an increased likelihood of recovery to 90% of baseline (P<0.001), especially for hospitalization compared to no new antibiotic.
For patients with idiopathic pulmonary fibrosis (IPF), fat-free mass index (FFMI) predicts survival, according to a study published online in Respirology.
The FDA has granted Fast Track designation to Aerosurf (lucinactant for inhalation; Windtree Therapeutics) for the treatment of respiratory distress syndrome (RDS) in premature infants.
Late administration of surfactant does not reduce the duration of ventilation in very preterm neonates with prolonged respiratory distress, according to research published online February 29 in JAMA Pediatrics.
Interstitial lung abnormalities correlate with increased risk of all-cause mortality, according to research published in the Journal of the American Medical Association.
Lung volume reduction coil treatment may help improve the ability to exercise for patients with severe emphysema, according to a study published in the January 12 issue of the Journal of the American Medical Association.
Gene therapy showed a significant benefit in lung function in patients with cystic fibrosis, data from a Phase 2 trial has shown.
Vertex Pharmaceuticals announced that the Food and Drug Administration (FDA) has approved Kalydeco (ivacaftor) for use in children ages 2-5 with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
The Food and Drug Administration (FDA) has approved PARI's eRapid Nebulizer System (eRapid), the first electronic nebulizer to deliver Pulmozyme (dornase alfa [recombinant human DNase]; Genentech) for the treatment of cystic fibrosis.
Vertex announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for the combination product lumacaftor and ivacaftor for people with cystic fibrosis (CF) ages ≥12 who have two copies of the F508del mutation in the cystic fibrosis transmembrance conductance regulator (CFTR) gene.
Children with cystic fibrosis (CF) have an increased risk of morbidity and higher case fatality during the influenza pandemic compared to patients with other chronic respiratory diseases or healthy controls.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to Lynovex (NM001; NovaBiotics) for the treatment of cystic fibrosis (CF).
Fresenius Kabi announced the launch of Acetylcysteine Solution, 10%.
Vertex announced results from two Phase 3 studies of lumacaftor in combination with ivacaftor in patients with cystic fibrosis (CF) who have two copies of F508del mutation in the CFTR gene.
Fresenius Kabi USA announced its launch of Acetylcysteine Solution 20% in 4mL vials for inhalation or oral administration.
The FDA has approved a sNDA for Kalydeco (ivacaftor; Vertex) for use in patients with cystic fibrosis (CF) ages >6 years old who have 1 of 8 additional mutations in the CF transmembrane conductance regulator (CFTR) gene.
Ben Venue Laboratories announced a nationwide recall of Roxane's Acetylcysteine Solution 10%.
Fresenius Kabi USA has announced the launch of Acetylcysteine Solution 20% in a 10mL vial for inhalation or oral administration.
There is currently a lack of evidence showing the benefit of certain therapies to clear mucus in the lungs when performed routinely in hospitals, according to the American Association for Respiratory Care (AARC).
Discovery Laboratories announced its launch of Surfaxin (lucinactant) Intratracheal Suspension for the prevention of respiratory distress syndrome (RDS) in premature infants at high-risk for RDS.
The FDA has approved updated product specifications for Surfaxin (lucinactant; Discovery Laboratories), allowing Discovery Laboratories to initiate manufacturing for its planned commercial introduction in the fourth quarter of 2013.
Vertex has submitted a supplemental New Drug Application (sNDA) to the FDA for the approval of Kalydeco (ivacaftor) monotherapy for people with cystic fibrosis (CF) ages 6 and older who have at least one non-G551D gating mutation in the CFTR gene.
JCB Laboratories has issued a recall of six lots of sterile drug products after a recent FDA inspection due to concern regarding unreliable and inaccurate sterility assurance tests.
Vertex announced results from an ongoing Phase 3 label-expansion study of Kalydeco (ivacaftor) monotherapy in patients with cystic fibrosis (CF) who have a non-G551D gating mutation.
In infants with acute bronchiolitis, on-demand inhalation of either adrenaline or saline are effective in shortening hospital stays and reducing the need for supportive treatment, compared with fixed-schedule inhalation.