NCT00103714

Brief Summary

The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

7 months

First QC Date

February 14, 2005

Last Update Submit

October 19, 2015

Conditions

Cystic Fibrosis

Keywords

lung disease

Outcome Measures

Primary Outcomes (1)

  • respiratory function

Secondary Outcomes (4)

  • adverse events

  • change in standard safety parameters

  • respiratory symptoms via questionnaire

  • pulmonary exacerbation

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:

  • Have confirmed diagnosis of CF
  • Have an FEV1 greater than or equal to 60% or less than or equal to 90% of predicted normal
  • Have oxygen saturation greater than or equal to 90% on room air
  • Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation
  • Be able to reproducibly perform spirometry maneuvers

You may not qualify if:

  • Have changed their physiotherapy technique or schedule within 7 days prior to screening
  • Have clinically significant comorbidities
  • Using prior and concurrent medications according to the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cystic FibrosisLung Diseases

Interventions

denufosol tetrasodium

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System 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

February 14, 2005

First Posted

February 15, 2005

Study Start

January 1, 2005

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

October 20, 2015

Record last verified: 2015-10