Safety, tolerability, and plasma exposure of tiotropium Respimat® in children and adults with cystic fibrosis.
BACKGROUND
People with cystic fibrosis (CF) suffer from chronic lung disease that is often treated with a bronchodilator. This trial evaluated the pharmacokinetics, safety, and tolerability of single and multiple doses of tiotropium inhaled via the Respimat® Soft Mist™ Inhaler in patients with CF.


METHODS
Patients received a single dose (placebo, 2.5 μg, 5 μg, or 10 μg) and/or multiple doses (placebo, 2.5 μg, or 5 μg) of tiotropium daily for 28 days.


RESULTS
Ninety-two patients, aged 5-57 years, were treated. All doses showed a satisfactory safety profile for adverse events, vital signs, laboratory evaluations, and physical examination. At steady-state, peak exposure to tiotropium was comparable between adult patients with CF and patients with chronic obstructive pulmonary disease.


CONCLUSIONS
Tiotropium 2.5 μg or 5 μg inhaled via the Respimat® Soft Mist™ Inhaler once daily was well tolerated in patients with CF.
1 Rainbow Babies and Children's Hospital and Case Western Reserve University School of Medicine , Cleveland, Ohio.
Michael W
MW
Konstan
Ashish
A
Sharma
Petra
P
Moroni-Zentgraf
Fei
F
Wang
Paul
P
Koker
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood* / Q000493:pharmacokinetics; D002648:Child; D002675:Child, Preschool; D018680:Cholinergic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood* / Q000493:pharmacokinetics; D003550:Cystic Fibrosis / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D000069447:Tiotropium Bromide / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood* / Q000493:pharmacokinetics; D014481:United States; D055815:Young Adult
D001993:Bronchodilator Agents; D018680:Cholinergic Antagonists; D000069447:Tiotropium Bromide
Respimat®; SPIRIVA®; cystic fibrosis; lung function; spirometry; tiotropium bromide