Cystic Fibrosis
Conditions
Interventions
Trade Name: Somalgen
Product Name: Talniflumate
Product Code: MSI-1995
Pharmaceutical Form: Tablet
INN or Proposed INN: Talniflumate
CAS Number: 66898-62-2
Current Sponsor code: MSI-1995
Concentration
Sponsors
Genaera Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject Inclusion Criteria Eligible subjects MUST comply with the following criteria: 1.Be 12 years of age or older, male or female 2.Have a confirmed diagnosis of CF: sweat chloride ³ 60 meq/L by quantitative pilocarpine iontophoresis test (QPIT) OR homozygosity for DF508 genetic mutation OR heterozygosity for two well?characterized mutations AND one or more clinical findings consistent with CF 3.Have a forced expiratory volume at 1 second (FEV1) at spirometry ³ 30% of predicted normal for age, gender, and height (Knudson standards) 4.Have an oxygen saturation (as measured by pulse oximetry) ³ 90% on room air 5.Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation, as described in Appendix 16.6 Signs and Symptoms of Pulmonary Exacerbation 6.Be able and willing to follow instructions and complete study procedures 7.Be able to be present for the required study visits 8.Provide written informed consent/assent 9.Be able to reproducibly perform spirometry maneuvers 10.All females must have a negative serum pregnancy test at the Screening Visit and be practicing a medically acceptable form of contraception (acceptable forms of contraception: hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent) or abstinence, unless surgically sterilized 11.Agree to avoid pregnancy, and not to nurse a child throughout the study (females of child-bearing potential) 12.If male, agree to use barrier contraception or abstinence throughout the study (unless surgically sterilized) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Eligible subjects MUST NOT: 1.Have abnormal renal or liver function (serum creatinine ³ 2 mg/dL or liver function tests [AST, ALT] ³ 3 ´ upper limit of normal) 2.Have other clinically significant comorbidities 3.Have a history of gastrointestinal bleeding, or peptic ulcer disease 4.Have ECG changes consistent with clinically significant cardiovascular disease 5.Have discontinued chronic oral or inhaled antimicrobial, bronchodilator, anti-inflammatory, or corticosteroid medications within two month prior to Screening 6.Have had changes in chronic oral or inhaled antimicrobial agents within six months prior to Screening (stable use for six months or longer is allowed) 7.Have had change in Pulmozyme (dornase alfa) treatment within six months prior to Screening (stable use for six months or longer is allowed) 8.Have discontinued Pulmozyme (dornase alfa) within 2 months prior to Screening 9.Be currently receiving an ACE inhibitor 10.Be receiving chronic ibuprofen or other NSAID therapy 11.Have changed their physiotherapy technique or schedule within the week prior to Screening 12.Be receiving new systemic corticosteroids prior to dosing 13.Have received new intravenous antibiotics within the four weeks prior to dosing with study medication 14.Have a history of daily continuous oxygen supplementation or require > 2L/min at night 15.Have an oxyhemoglobin saturation of less than 90% on room air 16.Have a history of hypersensitivity to any other NSAID 17.Have received antitussives, expectorants, or mucolytic agents including dextromethorphan, guaifenesin, menthol, camphor, codeine, iodinated glycerol, N-acetylcysteine within the 2 weeks prior to Screening 18.Have a condition (e.g., alcoholism, drug abuse, psychiatric condition) that makes it highly unlikely that the course of treatment or follow-up will be completed 19.Have a chest x-ray at screening (or within the past 6 months of screening) with evidence of an acute segmental or lobar process 20.Have been exposed to any investigational drug within 30 days prior to screening 21.Be pregnant, nursing, or expecting or attempting to become pregnant within the next year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the study are: To evaluate the safety profile of talniflumate compared with that of placebo when administered as two 370 mg tablets, three times daily for 52 weeks. To evaluate the efficacy of talniflumate compared with that of placebo when administered as two 370 mg tablets, three times daily for 52 weeks. ;Secondary Objective: To evaluate at Weeks 2, 4, 8, 20, 32, 46, 48, 50, 52, and Follow-up: Change from baseline in (pre- and post-bronchodilator) spirometric measurements of forced vital capacity (FVC) and FEV1. Change from baseline in respiratory rate. Change from baseline in oxyhemoglobin saturation level. Change from baseline in total lung capacity (TLC) and ratio of residual lung volume to total lung capacity (RV/TLC). Change from baseline in carbon monoxide diffusing capacity of the lung (DLCO). To evaluate at Weeks 8, 32, 52, and Follow-up: Acute Respiratory Illness Checklist (ARIC) scores. Gastrointestinal tolerability. To evaluate the effect of talniflumate on the subject’s health-related quality of life at Weeks 4, 20, 32, 46, 52, and Follow-up. To evaluate any dose modification from the baseline due to safety or tolerance. To assess the safety of talniflumate. ;Primary end point(s): Primary Endpoints Safety: The cumulative incidence, at Week 52, of adverse events. Efficacy: The change from baseline in spirometric (pre-bronchodilator) measurement of forced expiratory volume in one second (FEV1) at Week 52 | — |
Countries
Ireland
Outcome results
None listed