Suspended

Salmeterol and Albuterol Impact on Cystic Fibrosis Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Salmeterol

+ Albuterol

Drug
Who is being recruted

Digestive System Diseases+5

+ Infant, Newborn, Diseases

+ Lung Diseases

From 5 to 45 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00005110
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 5 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesInfant, Newborn, DiseasesLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPancreatic DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCystic Fibrosis

Criteria

7 inclusion criteria required to participate
A CF pulmonary exacerbation within the last year or an FEVI < 80%

Ability to demonstrate use of inhaled medicine and FEVI and PEFR monitor

Ability to perform reproducible spirometry

At least one delta f508 allele on CF mutation analysis

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Division of Allergy and Pulmonary Medicine

St Louis, United StatesOpen Division of Allergy and Pulmonary Medicine in Google Maps
SuspendedOne Study Center