A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects
Public ClinicalTrials.gov record NCT02134353. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This trial aims to provide prospective evidence of the safety and efficacy of mannitol 400 mg b.i.d. in subjects aged 18 years and above. We hypothesize that inhaled mannitol 400 mg b.i.d. will increase the mean change from baseline FEV1 (mL) compared to control over the 26-week treatment period in adult subjects with cystic fibrosis. Any improvement in FEV1 is considered clinically meaningful, however, this trial has set a threshold of 80 mL for the purposes of determining an appropriate sample size for statistical power while retaining trial feasibility in an orphan disease population
Study identification
- NCT ID
- NCT02134353
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 423 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2014 (Actual)
- Primary completion
- Feb 2017 (Actual)
- Completion
- Feb 2017 (Actual)
- Last update posted
- Oct 28, 2020
2014 – 2017
United States locations
- U.S. sites
- 36
- U.S. states
- 22
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dr Lawrence Sinde | Mobile | Alabama | 36608 | — |
| University of Arizona | Tucson | Arizona | 85724 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Pediatric Pulmonology | Long Beach | California | 90806 | — |
| University of CA, Davis | Sacramento | California | 95817 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Dr Mitchell Rothstein | Jacksonville | Florida | 32204 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Central Florida Pulmonary Group, P.A. | Orlando | Florida | 32803 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Cystic Fibrosis Center of Chicago | Glenview | Illinois | 60025 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Illinois Lung Institute | Peoria | Illinois | 61537 | — |
| University of Kansas Hospital | Kansas City | Kansas | 64081 | — |
| Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky | 40202 | — |
| John Hopkins | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 62114 | — |
| Spectrum Health Offices of Research Administration | Grand Rapids | Michigan | 49503 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Dr Joseph Ojile | St Louis | Missouri | 63143 | — |
| Dartmouth-Hitchcock Specialty Care | Bedford | New Hampshire | 03110 | — |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | — |
| The Cystic Fibrosis Center Beth Israel Medical Center | New York | New York | 10003 | — |
| Dr Allen Dozor | Valhalla | New York | 10595 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267-0564 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| The Children's Medical Center of Dayton | Dayton | Ohio | 45404 | — |
| The Toledo Hospital and Toledo Childrens Hospital | Toledo | Ohio | 43606 | — |
| Pediatric Pulmonary & CF Center | Oklahoma City | Oklahoma | 73104 | — |
| Dr Santiago Reyes | Oklahoma City | Oklahoma | 73112 | — |
| Pediatric Clinic | Portland | Oregon | 97227 | — |
| Medical University of SC | Charleston | South Carolina | 29425 | — |
| One Richland Medical Park | Columbia | South Carolina | 29203 | — |
| University of Washington | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 64 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02134353, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 28, 2020 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02134353 live on ClinicalTrials.gov.