Study of INS37217 Inhalation Solution in Mild to Moderate... | NCT00056147

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

NCT00056147

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Jan 29, 2015Estimated

Enrollment

90Actual

Phase

Phase 2

Conditions

Cystic Fibrosis

Interventions

denufosol tetrasodium (INS37217)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Apr 2003

Primary Completion Date

Feb 2004Actual

Completion Date

Feb 2004Actual

First Submitted Date

Mar 6, 2003

First Submission Date that Met QC Criteria

Mar 6, 2003

First Posted Date

Mar 7, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2015

Last Update Posted Date

Jan 29, 2015Estimated

Name	Class
Cystic Fibrosis Foundation	OTHER

Description Module

Brief 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).

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Name	Type	Description	Arm Group Labels	Other Names
denufosol tetrasodium (INS37217)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
lung function
respiratory symptoms
sputum weight
pulmonary exacerbations
measures of lung characteristics

Secondary Outcomes

Measure	Description	Time Frame
safety measures

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Amy Schaberg, BSN		Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17446337	Result	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 tetrasodium in cystic fibrosis. Am J Respir Crit Care Med. 2007 Aug 15;176(4):362-9. doi: 10.1164/rccm.200608-1238OC. Epub 2007 Apr 19.

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases