NCT00177645

Brief Summary

The purpose of this study is to see if inhaled bicarbonate will increase the ability to cough up mucus in a person with cystic fibrosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

September 7, 2023

Status Verified

January 1, 2016

Enrollment Period

4.8 years

First QC Date

September 13, 2005

Last Update Submit

September 6, 2023

Conditions

Cystic Fibrosis

Keywords

cystic fibrosismucus clearance

Outcome Measures

Primary Outcomes (1)

  • Determine the acute effects of increasing doses of inhaled bicarbonate on mucociliary clearance after a single inhalation

    single dose escalation

Secondary Outcomes (2)

  • comparison of pre- and post-bicarbonate exhaled breath condensate pH values at a single inhalation

    two doses in single day

  • Safety as determined by pre- and post-clearance assay pulmonary function tests (FEV1) at a single visit

    two doses in single day

Study Arms (1)

sodium bicarbonate

EXPERIMENTAL

inhaled sodium bicarbonate

Procedure: sodium bicarbonate

Interventions

sodium bicarbonatePROCEDURE

inhalation of sodium bicarbonate or sodium chloride

sodium bicarbonate

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • age 12 or older
  • Forced expiratory volume in one second (FEV1) \>40% predicted
  • Ability to expectorate sputum

You may not qualify if:

  • pregnancy
  • pulmonary exacerbation or initiation of inhaled or oral antibiotics, steroids, or aerosol treatments within the last four weeks
  • oxygen saturation \<92%, or requirement for supplemental oxygen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Officials

  • Joseph M Pilewski, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

March 1, 2002

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

September 7, 2023

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)