Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease

Cystic Fibrosis Clinical Trial

Official title:

Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of INS37217 Inhalation Solution in Subjects With Mild to Moderate Cystic Fibrosis Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056147
• Other study ID #: 08-103
• Status: Completed
• Phase: Phase 2
• First received: March 6, 2003
• Last updated: January 28, 2015
• Start date: April 2003
• Est. completion date: February 2004

Study information

• Verified date: January 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 study is to assess the safety and effectiveness of multiple dosages of INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis (CF) lung disease. Study drug will be administered through a nebulizer (a device that delivers medication as a mist by breathing it in).

Description:

The purpose of this study is to:

• assess the safety and efficacy of multiple dose levels of INS37217 compared to placebo over 28 days in subjects with mild to moderate CF lung disease;

• explore evidence of activity of INS37217 and placebo administered via PARI LC STAR nebulizer;

• identify dose(s) that will be studied in subsequent trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 50 Years

Eligibility

Inclusion Criteria:

• confirmed diagnosis of CF

• FEV1 greater than or equal to 75% of predicted normal for age, gender, and height

• oxyhemoglobin saturation greater than or equal to 90%

• clinically stable

Exclusion Criteria:

• abnormal renal or liver function

• clinically significant findings atypical for moderate cystic fibrosis

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
• Lung Diseases
• Pulmonary Fibrosis

Intervention

Drug:
• denufosol tetrasodium (INS37217)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Cystic Fibrosis Foundation Therapeutics

References & Publications (1)

Deterding RR, Lavange LM, Engels JM, Mathews DW, Coquillette SJ, Brody AS, Millard SP, Ramsey BW; Cystic Fibrosis Therapeutics Development Network and the Inspire 08-103 Working Group. Phase 2 randomized safety and efficacy trial of nebulized denufosol te — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lung function
Primary	respiratory symptoms
Primary	sputum weight
Primary	pulmonary exacerbations
Primary	measures of lung characteristics
Secondary	safety measures