Clinical Trials Logo

Clinical Trial Summary

Long term use of bronchodilators in CF is beneficial to the improvement of pulmonary function and symptoms. This study is investigating the long-term benefit of administration of the drug Salmeterol, a bronchodilator. Salmeterol will be compared to albuterol or placebo. The medication will be inhaled twice a day for 6 months.

Clinical Trial Description

Patients that have been diagnosed with cystic fibrosis and are above 5 years and below 45 years of age are eligible. Subjects will be randomized into 1 of 3 groups. One group will get Salmeterol by multi-dose inhaler (MDI) 2 puffs 2 times a day, one group will get albuterol by MDI 2 puffs 2 times a day and the other will get placebo by MDI 2 puffs 2 times a day. Height and weight along with pulmonary function testing and vital signs will be monitored at the beginning of the study and at Visits 2, 3, and 4. Peak flow monitoring will be done each morning before study medication at home. A daily diary will be kept of this measurement. Subjects will be seen in the research center at visits 1,2,3, and 4. Telephone contact will be done at Day 15, 60, 120, and 150. Individual outcomes include a potential increase in pulmonary function testing and a decrease in frequency of pulmonary exacerbations, hospitalizations, and usage of antibiotics. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

NCT number NCT00005110
Study type Interventional
Source National Center for Research Resources (NCRR)
Status Suspended
Phase N/A

See also
  Status Clinical Trial Phase
Recruiting NCT02769637 - Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF) N/A
Completed NCT02449785 - Assessment of Cystic Fibrosis Lung Involvement With UTE Pulse Sequences N/A
Terminated NCT02170025 - Early Signs of Efficacy Study With Riociguat in Adult Homozygous Delta F508 Cystic Fibrosis Patients Phase 2
Completed NCT02465450 - Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis Phase 2
Recruiting NCT03335202 - Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis N/A
Recruiting NCT03309358 - A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis Phase 1
Completed NCT00903201 - 28 Day Repeat Dose in Cystic Fibrosis Patients Phase 2
Recruiting NCT03181932 - A Study of AeroVanc for the Treatment of MRSA Infection in CF Patients Phase 3
Active, not recruiting NCT02721498 - Improving Outcome Measures For Adult CF ACT Trials N/A
Active, not recruiting NCT02730208 - A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Phase 2
Completed NCT02875366 - A Study of the Effects of Lumacaftor/Ivacaftor on Exercise Tolerance in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation Phase 4
Not yet recruiting NCT02894619 - Urinary and Anorectal Functional Disorders and Their Impact on CF Adults (PerineoMucoRMO) N/A
Completed NCT02823964 - EASY: Extended Access to Sollpura Over Years Phase 4
Completed NCT02504827 - Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis Phase 4
Completed NCT02421120 - Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients Phase 4
Completed NCT02564354 - Exploratory Study to Evaluate QR-010 in Subjects With Cystic Fibrosis ΔF508 CFTR Mutation Phase 1
Recruiting NCT02225899 - BioEnergetics and Metabolomics in Cystic Fibrosis N/A
Recruiting NCT02907788 - Inflammatory Markers in Broncho-alveolar Lavage Fluid as Risk Factors for Lung Disease in Infants With Cystic Fibrosis: the I-BALL Study N/A
Completed NCT02803944 - Continuous Azithromycin in Cystic Fibrosis Patients Beyond Two Years N/A
Completed NCT02212587 - Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex Phase 1