|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT01002534 |
|
Date of registration:
|
26/10/2009 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Does a Nasal Instillation of Vardenafil Normalize the Nasal Potential Difference in Cystic Fibrosis Patients?
|
|
Scientific title:
|
Does a Nasal Instillation of Vardenafil Normalize the Nasal Potential Difference in Cystic Fibrosis Patients Homozygous for the F508del Mutation? A Randomized, Double Blind, Placebo-controlled Study. |
|
Date of first enrolment:
|
October 2011 |
|
Target sample size:
|
5 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT01002534 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Belgium
| | | | | | | |
|
Contacts
|
|
Name:
|
Anissa LEONARD, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Cliniques universitaires St.Luc (Université Catholique de Louvain) |
|
|
Name:
|
Teresinha LEAL, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Cliniques universitaires St.Luc ( Université Catholique de Louvain) |
|
|
Name:
|
Patrick LEBECQUE, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Cliniques universitaires St.Luc (Université catholique de Louvain) |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Age minimum:
14 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Cystic Fibrosis
|
|
Intervention(s)
|
|
Drug: Placebo
|
|
Drug: Vardenafil
|
|
Primary Outcome(s)
|
|
Cumulated changes in response to Chloride-free solution and isoproterenol (reflecting chloride transport)
[Time Frame: Change from baseline (visit 1) and placebo to Vardenafil instillation]
|
|
Secondary Outcome(s)
|
|
Change in basal voltage value and in amiloride response (reflecting sodium transport)
[Time Frame: Change from baseline (visit1) and placebo to Vardenafil instillation]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|