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Main
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Note: This record shows only the 20 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00671736 |
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Date of registration:
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30/04/2008 |
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Primary sponsor: |
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Public title:
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Lancovutide (Moli1901) Inhalation Solution Study in Adolescents and Adults With Cystic Fibrosis
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults With Cystic Fibrosis |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00671736 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Austria
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Contacts
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Name:
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Ernst Eber, Prof Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of Graz |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Body mass index
- Confirmed diagnosis of cystic fibrosis
- FEV1 between 50% and 85% of predicted
- Oxygen saturation level measured by pulse oximetry (SpO2) >90 % on room air
Exclusion Criteria:
- Bronchial hyperresponsiveness
- Unstable lung function
- Pulmonary disease such as pneumonia, tuberculosis, or lung cancer
- Acute upper respiratory tract infection within the last 2 weeks
- Acute lower respiratory tract infection (requiring antibiotics or hospitalization)
within the last 4 weeks
- Pulmonary exacerbation within the last 4 weeks
- Changes from routine maintenance therapy within the last 4 weeks
- Scheduled changes to inhaled antibiotics regimen during the course of the study
- Receive or are planned to receive any treatment via "on-off" regimen (e.g. Tobramycin
- TOBI®); last dose of any "on-off" treatment within the last 6 weeks
- Any clinically significant liver, renal, cardiac, neurological, or hematological
disease
- ABPA or colonization with Burkholderia cepacia
- Poorly controlled diabetes mellitus
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Moli1901
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Drug: Moli1901 placebo
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Primary Outcome(s)
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The change in the percentage of the predicted FEV1 (forced expiratory volume in first second) value
[Time Frame: at every study visit]
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Secondary Outcome(s)
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The ensemble of two subject reported clinical scores, which are physical dimensions of the self-report, disease-specific quality of life test, the cystic fibrosis questionnaire in the revised version
[Time Frame: every 2 weeks]
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Secondary ID(s)
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EudraCT No 2006-006693-24
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Moli1901-010B
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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