NCT00056147

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2003

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2003

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2003

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

January 29, 2015

Status Verified

January 1, 2015

Enrollment Period

10 months

First QC Date

March 6, 2003

Last Update Submit

January 28, 2015

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis

Outcome Measures

Primary Outcomes (5)

  • lung function

  • respiratory symptoms

  • sputum weight

  • pulmonary exacerbations

  • measures of lung characteristics

Secondary Outcomes (1)

  • safety measures

Interventions

denufosol tetrasodium (INS37217)DRUG

Eligibility Criteria

Age8 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • abnormal renal or liver function
  • clinically significant findings atypical for moderate cystic fibrosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 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.

    PMID: 17446337RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

denufosol tetrasodium

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Amy Schaberg, BSN

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2003

First Posted

March 7, 2003

Study Start

April 1, 2003

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

January 29, 2015

Record last verified: 2015-01