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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-02-29

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis

Keywords

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cystic fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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denufosol tetrasodium (INS37217)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Schaberg, BSN

Role: STUDY_DIRECTOR

Countries

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United States

References

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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.

Reference Type RESULT

PMID: 17446337 (View on PubMed)

Other Identifiers

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08-103

Identifier Type: -

Identifier Source: org_study_id