NCT01002534

Brief Summary

The purpose of this study is to investigate the effect of a nasal instillation of Vardenafil on nasal potential difference in cystic fibrosis patients homozygous for the F508del mutation

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
1.9 years until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

October 26, 2009

Last Update Submit

February 21, 2019

Conditions

Cystic Fibrosis

Keywords

Cystic FibrosisVardenafilNasal instillationNasal Potential difference

Outcome Measures

Primary Outcomes (1)

  • Cumulated changes in response to Chloride-free solution and isoproterenol (reflecting chloride transport)

    Change from baseline (visit 1) and placebo to Vardenafil instillation

Secondary Outcomes (1)

  • Change in basal voltage value and in amiloride response (reflecting sodium transport)

    Change from baseline (visit1) and placebo to Vardenafil instillation

Study Arms (3)

baseline

NO INTERVENTION

visit 1

Vardenafil

ACTIVE COMPARATOR

nasal instillation of Vardenafil ( visit 2 or 3)

Drug: Vardenafil

Placebo

PLACEBO COMPARATOR

Nasal instillation of placebo (visit 3 or 2)

Drug: Placebo

Interventions

VardenafilDRUG

Nasal instillation of Vardenafil

Vardenafil
PlaceboDRUG

Nasal instillation of placebo matching in appearance with the Vardenafil instillation

Placebo

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Cystic fibrosis patients homozygous for the F508del mutation as confirmed by a genetic test
  • Aged 14 years and older
  • Male and female
  • FEV1 \>50% of predicted normal

You may not qualify if:

  • Acute respiratory tract infection or pulmonary exacerbation requiring antibiotic intervention within 2 weeks of visit 1
  • Any condition prohibiting the correct measurement of the NPD
  • Active or passive smoking
  • Planned treatment or treatment with another investigational drug or therapy within 1 month prior to randomisation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires St. Luc

Brussels, 1200, Belgium

Location

Related Publications (2)

  • Dormer RL, Harris CM, Clark Z, Pereira MM, Doull IJ, Norez C, Becq F, McPherson MA. Sildenafil (Viagra) corrects DeltaF508-CFTR location in nasal epithelial cells from patients with cystic fibrosis. Thorax. 2005 Jan;60(1):55-9. doi: 10.1136/thx.2003.019778.

    PMID: 15618584RESULT

  • Lubamba B, Lecourt H, Lebacq J, Lebecque P, De Jonge H, Wallemacq P, Leal T. Preclinical evidence that sildenafil and vardenafil activate chloride transport in cystic fibrosis. Am J Respir Crit Care Med. 2008 Mar 1;177(5):506-15. doi: 10.1164/rccm.200703-344OC. Epub 2007 Nov 15.

    PMID: 18006891RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Patrick LEBECQUE, MD, PhD

    Cliniques universitaires St.Luc (Université catholique de Louvain)

    PRINCIPAL INVESTIGATOR

  • Teresinha LEAL, MD, PhD

    Cliniques universitaires St.Luc ( Université Catholique de Louvain)

    PRINCIPAL INVESTIGATOR

  • Anissa LEONARD, MD

    Cliniques universitaires St.Luc (Université Catholique de Louvain)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

October 1, 2011

Primary Completion

June 1, 2012

Study Completion

March 1, 2018

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations

BE(1)