A Study in Adult and Pediatric Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Ph 1b/2a Study to Assess Levels of INS37217 and Placebo Treatment With Maximum Tolerated Dose Administered by Inhalation Via the Pari LC Star Nebulizer in Adult and Pediatric CF Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034515
• Other study ID #: 08-102
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 29, 2002
• Last updated: February 13, 2015
• Start date: June 2001
• Est. completion date: August 2002

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this ascending dose group study is to assess the safety, tolerability, and effects of multiple dose levels of INS37217 and placebo followed by five days twice daily treatment with maximum tolerated dose administered by inhalation via the Pari LC Star nebulizer in adult and pediatric patients with cystic fibrosis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 2002
• Est. primary completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• FEV1 40-70% (adults)

• FEV1 >/=50% (pediatrics)

• oxygen saturation >90%

• clinically stable

• willing to stay overnight

Exclusion Criteria:

• abnormal renal or liver function

• receiving corticosteroids exceeding 10mg/day or 20 mg every other day

• received intravenous or aerosolized antibiotics 1 week prior to dosing

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• denufosol tetrasodium (INS37217) Inhalation Solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Deterding R, Retsch-Bogart G, Milgram L, Gibson R, Daines C, Zeitlin PL, Milla C, Marshall B, Lavange L, Engels J, Mathews D, Gorden J, Schaberg A, Williams J, Ramsey B; Cystic Fibrosis Foundation Therapeutics Development Network. Safety and tolerability — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess safety and tolerability
Secondary	assess effects of INS37217 on sputum weight and symptoms