Clinical trials: Cystic Fibrosis Pulmonary Exacerbation
Cystic Fibrosis
Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12 years of age or older.
- Trial name
- NCT03451045
- Testing
- Lenabasum 20 mg, Lenabasum 5 mg
- Where
- 105 sites in United States, Austria and 19 more
- Volunteers
- 447 people
- Sponsor
- Corbus Pharmaceuticals Inc.
Cystic Fibrosis, Pneumonia
Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
This study will determine the concentrations of the antibiotic meropenem when administered as a 3 hour prolonged infusion in children with cystic fibrosis who are hospitalized with an acute pulmonary exacerbation.
- Conditions
- Cystic Fibrosis, Pneumonia, Pseudomonas Aeruginosa Infection
- Trial name
- NCT01429259
- Testing
- meropenem
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- Joseph Kuti
Non Cystic Fibrosis Bronchiectasis
Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium.
The primary objective of the trial was to investigate the effect of the use of inhaled colistimethate sodium (CMS), administered twice a day (b.i.d.) via a specific nebulizer for 12 months, compared to placebo in subjects with…
- Trial name
- PROMIS-II (NCT03460704)
- Testing
- CMS
- Where
- 89 sites in United States, Argentina and 10 more
- Volunteers
- 287 people
- Sponsor
- Zambon SpA
Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation
Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients
There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients.
- Conditions
- Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation, Pseudomonas Aeruginosa Infection
- Trial name
- NCT02421120
- Testing
- Ceftolozane/Tazobactam
- Where
- 4 sites in United States
- Volunteers
- 21 people
- Sponsor
- Joseph L. Kuti, PharmD
Ototoxicity
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing…
- Trial name
- NCT02819856
- Testing
- SPI-1005 Ebselen 200mg Capsule x1, SPI-1005 Ebselen 200mg Capsule x2, SPI-1005 Ebselen 200mg Capsule x3
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Sound Pharmaceuticals, Incorporated
Cystic Fibrosis
Early Intervention in Cystic Fibrosis Exacerbation
Individuals with cystic fibrosis (CF) develop chronic lung infections and suffer intermittent acute exacerbations of their lung disease.
- Trial name
- eICE (NCT01104402)
- Testing
- Home lung function and symptom monitoring
- Where
- 3 sites in United States
- Volunteers
- 267 people
- Sponsor
- Johns Hopkins University
Pulmonary Cystic Fibrosis
Standardized Treatment of Pulmonary Exacerbations II
Cystic fibrosis (CF), a life-shortening genetic disease, is marked by acute episodes during which symptoms of lung infection increase and lung function decreases.
- Trial name
- STOP2 (NCT02781610)
- Testing
- Standard of care IV antibiotic(s)
- Where
- 58 sites in United States, Canada
- Volunteers
- 982 people
- Sponsor
- Chris Goss
Bronchiectasis
Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14…
- Trial name
- RESPIRE 1 (NCT01764841)
- Testing
- Ciprofloxacin DPI (BAYQ3939)
- Where
- 151 sites in United States, Argentina and 12 more
- Volunteers
- 416 people
- Sponsor
- Bayer
Cystic Fibrosis
A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations
This study investigates the use of cysteamine in the treatment of adults with Cystic Fibrosis who are experiencing an exacerbation of CF-associated lung disease.
- Trial name
- CARE-CF1 (NCT03000348)
- Testing
- Cysteamine
- Where
- 17 sites in United States, Italy and 1 more
- Volunteers
- 91 people
- Sponsor
- NovaBiotics Ltd.
Bronchiectasis
Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14…
- Trial name
- RESPIRE 2 (NCT02106832)
- Testing
- Ciprofloxacin (BAYQ3939) dry powder for inhalation
- Where
- 207 sites in United States, Argentina and 23 more
- Volunteers
- 521 people
- Sponsor
- Bayer
Cystic Fibrosis
Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis
Cystic fibrosis is an inherited disorder leading to chronic pulmonary inflammation and infection. A majority of people with cystic fibrosis have large quantities of bacteria residing in their lungs.
- Trial name
- PIPE-CF (NCT01694069)
- Testing
- Piperacillin-tazobactam combination product
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- West Virginia University
Cystic Fibrosis
OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis
The purpose of this trial is to compare the effects of treatment with tobramycin solution for inhalation (TIS) with and without azithromycin in people with cystic fibrosis (CF) age 6 months to 18 years who have early isolation of…
- Trial name
- OPTIMIZE (NCT02054156)
- Testing
- azithromycin, Tobramycin solution for inhalation
- Where
- 45 sites in United States
- Volunteers
- 221 people
- Sponsor
- Bonnie Ramsey
Cystic Fibrosis
Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Cystic Fibrosis (CF) Subjects
Cystic fibrosis (CF) lung disease is characterized by chronic bacterial colonization and recurrent infection of the airways. Lowering the airway surface liquid (ASL) salt concentration has been shown to increase activity of salt…
- Trial name
- NCT00928135
- Testing
- Xylitol, Hypertonic saline
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Joseph Zabner