From: Subject: NEJM -- A Controlled Trial of Long-Term Inhaled Hypertonic Saline in Patients with Cystic Fibrosis Date: Sat, 19 Apr 2008 08:06:35 +0200 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0031_01C8A1F4.497E8660" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_0031_01C8A1F4.497E8660 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://content.nejm.org/cgi/content/abstract/354/3/229 NEJM -- A Controlled Trial of Long-Term Inhaled = Hypertonic Saline in Patients with Cystic Fibrosis
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A=20 Controlled Trial of Long-Term Inhaled Hypertonic Saline in Patients with = Cystic=20 Fibrosis
Mark R. Elkins, M.H.Sc., Michael Robinson, = Ph.D.,=20 Barbara R. Rose, Ph.D., Colin Harbour, Ph.D., Carmel P. Moriarty, R.N., = Guy B.=20 Marks, Ph.D., Elena G. Belousova, M.Appl.Sc., Wei Xuan, Ph.D., Peter = T.P. Bye,=20 Ph.D., for the National Hypertonic Saline in Cystic Fibrosis (NHSCF) = Study Group=20

 
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ABSTRACT

Background Inhaled hypertonic = saline=20 acutely increases mucociliary clearance and, in short-term = trials,=20 improves lung function in people with cystic fibrosis. We = tested the=20 safety and efficacy of inhaled hypertonic saline in a = long-term=20 trial.

Methods In this double-blind, parallel-group trial, 164 = patients=20 with stable cystic fibrosis who were at least six years old=20 were randomly assigned to inhale 4 ml of either 7 percent = hypertonic=20 saline or 0.9 percent (control) saline twice daily for 48 = weeks,=20 with quinine sulfate (0.25 mg per milliliter) added to each=20 solution to mask the taste. A bronchodilator was given before = each dose, and other standard therapies were continued during = the trial.

Results The primary outcome measure, the rate of change = (slope)=20 in lung function (reflected by the forced vital capacity = [FVC],=20 forced expiratory volume in one second [FEV1], and = forced=20 expiratory flow at 25 to 75 percent of FVC = [FEF25=9675])=20 during the 48 weeks of treatment, did not differ = significantly=20 between groups (P=3D0.79). However, the absolute difference = in lung=20 function between groups was significant (P=3D0.03) when = averaged=20 across all post-randomization visits in the 48-week treatment = period. As compared with the control group, the = hypertonic-saline=20 group had significantly higher FVC (by 82 ml; 95 percent=20 confidence interval, 12 to 153) and FEV1 (by 68 = ml; 95=20 percent confidence interval, 3 to 132) values, but similar=20 FEF25=9675 values. The hypertonic-saline group = also had=20 significantly fewer pulmonary exacerbations (relative = reduction, 56=20 percent; P=3D0.02) and a significantly higher percentage of = patients=20 without exacerbations (76 percent, as compared with 62 = percent in the=20 control group; P=3D0.03). Hypertonic saline was not = associated with=20 worsening bacterial infection or inflammation.

Conclusions Hypertonic saline preceded by a bronchodilator = is=20 an inexpensive, safe, and effective additional therapy for = patients=20 with cystic fibrosis. (ClinicalTrials.gov number, NCT00271310=20 [ClinicalTrials.gov]=20 .)


Source=20 Information

From the Department of Respiratory Medicine, Royal = Prince=20 Alfred Hospital (M.R.E., M.R., C.P.M., P.T.P.B.); the Departments of = Medicine=20 (M.R.E., G.B.M., P.T.P.B.) and Microbiology and Infectious Diseases = (B.R.R.,=20 C.H.), University of Sydney; and the Woolcock Institute of Medical = Research=20 (G.B.M., E.G.B., W.X., P.T.P.B.) =97 all in Sydney.

Address reprint requests to Dr. Bye at the Department = of=20 Respiratory Medicine, Level 11 E Block, Royal Prince Alfred Hospital, = Missenden=20 Rd., Camperdown 2050, Australia, or at peterb{at}med.usyd.edu.au .

Full Text of = this=20 Article


Related Letters:=20

Hypertonic= Saline=20 for Cystic Fibrosis
Aziz I., Kastelik J. A., Zarogiannis = S.,=20 Hatzoglou C., Gourgoulianis K., Kuver R., Lee S. P., Bye P. T.P., Elkins = M. R.,=20 Donaldson S. H., Tarran R., Boucher R. C., Ratjen F.
Extract<= /A> | Full = Text | PDF =  
N=20 Engl J Med 2006; 354:1848-1851, Apr 27, 2006. Correspondence =

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  • Mackay, A J (2006). Inhaled hypertonic saline reduces pulmonary=20 exacerbations in cystic fibrosis. Thorax 61: 353-353 [Full = Text]=20  =20
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  • Tonks, A. (2006). What's new in the other general journals. = BMJ=20 332: 225-226 [Full = Text]=20  =20
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 ' = + ' 

' +=20 '

' +=20 'How useful is this Audio Interview?

' + '
  • ' + '
    • ' + '
  • ' + '
    • ' + '
  • ' + '
' + '

I am a:

' + '
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    • ' + '
  • ' + '
    • ' + '
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    • ' + '
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' + '
 
', =09 '

 ' +=20 ' 

' + '

' +=20 'Thanks for participating in this survey.

' + '
 
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768; if (CM8IsIE) { if (typeof(window.document.body.clientWidth) !=3D 'undefined') { width =3D window.document.body.clientWidth; height =3D window.document.body.clientHeight; } if (CM8IsFrames()) { width =3D window.parent.document.body.clientWidth; height =3D window.parent.document.body.clientHeight; } } else if (CM8IsNav&& (typeof(window.innerWidth) !=3D 'undefined')) { width =3D window.innerWidth; height =3D window.innerHeight; } var width_group; if (width > 1200) width_group =3D "WR_E"; else if (width > 1000) width_group =3D "WR_D"; else if (width > 800) width_group =3D "WR_C"; else if (width > 600) width_group =3D "WR_B"; else width_group =3D "WR_A"; return "WIDTH=3D" + width + "&HEIGHT=3D" + height + "&WIDTH_RANGE=3D" + = width_group; } function CM8ConvertChar(source,charX) { var d1=3D(charX.charCodeAt(0)/16)%16; var d2=3DcharX.charCodeAt(0)%16 var to=3D"%"+ = String.fromCharCode((d1<10)?("0".charCodeAt(0)+d1):("a".charCodeAt(0)+d1-= 10))+ = String.fromCharCode((d2<10)?("0".charCodeAt(0)+d2):("a".charCodeAt(0)+d2-= 10)); while (source.indexOf(charX)!=3D-1) = source=3Dsource.slice(0,source.indexOf(charX))+to+source.slice(source.ind= exOf(charX)+1); return source; } function CM8GetLocation() { var encoded =3D []; var loc =3D document.location.href; for (var i =3D 0; i < loc.length; i++) { var code =3D loc.charCodeAt(i); if ((code >=3D 256) || (code =3D=3D 32)) encoded.push(encodeURIComponent(loc.substr(i, 1))); else if (code =3D=3D 92) // \ encoded.push("\\\\"); else if (code =3D=3D 63) // ? encoded.push("\\q"); else if (code =3D=3D 38) // & encoded.push("\\a"); else if (code =3D=3D 37) // % encoded.push("\\p"); else encoded.push(loc.substr(i, 1)); } return encoded.join(""); } function CM8EncodeProfile(profile) { var attrs =3D profile.split("&"); for (var i =3D 0; i < attrs.length; i++) { var pair =3D attrs[i].split("=3D", 2); if (pair.length > 0) { var attr =3D pair[0]; if (attr.toLowerCase().indexOf("encoded:") =3D=3D 0) { attr =3D attr.substring(8); } else { attr =3D encodeURIComponent(attr); } pair[0] =3D attr; } if (pair.length > 1) { var value =3D pair[1]; if (value.toLowerCase().indexOf("encoded:") =3D=3D 0) { value =3D value.substring(8); } else { value =3D encodeURIComponent(value); } pair[1] =3D value.replace(/%2C/g, ","); } attrs[i] =3D pair.join("=3D"); } return attrs.join("&"); } if ((typeof(CM8Profile) =3D=3D "undefined") || (CM8Profile=3D=3D "")) var CM8Profile=3D ""; else CM8Profile=3D CM8EncodeProfile(CM8Profile) + "&"; CM8Profile+=3D "LOC=3D" + CM8GetLocation().substr(0,1000) + "&" + CM8GetSize() + "&" +=20 CM8GetTime() + "&ORD=3D" + String(Math.random()).slice(2); if (CM8Cat.toLowerCase().indexOf("encoded:") =3D=3D 0) { CM8Cat =3D CM8Cat.substring(8); } else { CM8Cat =3D encodeURIComponent(CM8Cat); } // Copyright Ma Bingyao = http://www.coolcode.cn/?p=3D126###pp=3D2 if (typeof(decodeURIComponent) =3D=3D "undefined") window.decodeURIComponent =3D function(str) { function checkcode() {=20 var d1, d2;=20 d1 =3D str.charAt(i++);=20 d2 =3D str.charAt(i++);=20 if (isNaN(parseInt(d1, 16)) || isNaN(parseInt(d2, 16))) return null; return parseInt(d1 + d2, 16);=20 }=20 function checkutf8() {=20 var c =3D str.charCodeAt(i++);=20 if (c =3D=3D 37) { if ((c =3D checkcode()) =3D=3D null) return null;=20 }=20 if ((c >> 6) !=3D 2) return null; return c; }=20 var out, i, len;=20 var c, c2, c3;=20 =20 out =3D [];=20 len =3D str.length;=20 i =3D 0;=20 while(i < len) {=20 c =3D str.charCodeAt(i++);=20 if (c =3D=3D 37) {=20 if ((c =3D checkcode()) =3D=3D null) return "";=20 }=20 else {=20 out[out.length] =3D String.fromCharCode(c);=20 continue;=20 }=20 switch(c >> 4) {=20 case 0: case 1: case 2: case 3: case 4: case 5: case 6: case 7: {=20 // 0xxxxxxx=20 out[out.length] =3D String.fromCharCode(c);=20 break;=20 }=20 case 12: case 13: {=20 // 110x xxxx 10xx xxxx=20 if ((c2 =3D checkutf8()) =3D=3D null) return "";=20 out[out.length] =3D String.fromCharCode(((c & 0x1F) << 6) | (c2 & = 0x3F));=20 break;=20 }=20 case 14: {=20 // 1110 xxxx 10xx xxxx 10xx xxxx=20 if ((c2 =3D checkutf8()) =3D=3D null) return "";=20 if ((c3 =3D checkutf8()) =3D=3D null) return "";=20 out[out.length] =3D String.fromCharCode(((c & 0x0F) << 12) |=20 ((c2 & 0x3F) << 6) | ((c3 & 0x3F) << 0));=20 break;=20 }=20 default: {=20 return "";=20 }=20 }=20 }=20 return out.join('');=20 } if ((typeof(CM8RichMedia) !=3D "undefined") && ((CM8RichMedia.toString().toLowerCase() =3D=3D "no") || (CM8RichMedia.toString().toLowerCase() =3D=3D "false"))) CM8RichMedia =3D ""; else CM8RichMedia =3D "r"; var CM8ShowAd =3D function(F, I) { if (F.toLowerCase().indexOf("encoded:") =3D=3D 0) { F =3D F.substring(8); } else { F =3D encodeURIComponent(F); } F =3D decodeURIComponent(F); if (document.getElementById('CM8_FORMAT_' + F) =3D=3D null) document.write('
'); if (typeof(CM8MultiShow) !=3D "undefined") CM8MultiShow(F, I); }; if (! window.CM8InternalFSF) { window.CM8InternalFSF =3D true; document.write(""); } ------=_NextPart_000_0031_01C8A1F4.497E8660 Content-Type: application/octet-stream Content-Transfer-Encoding: quoted-printable Content-Location: http://survey.nejm.org/scripts/survey.js function invite(inviteurl,frmWidth,frmHeight,svyName,expire) { //******************************************************************** // Display invitation if specific cookie not found and set cookie // Parameters // inviteurl: URL of invite form // frmWidth & frmHeight: dimensions of invitation window // svyName: Name of the specific survey // expire: Number of days before cookie expires //=20 // Created by Chris Miceli 2/25/2004 //******************************************************************** // define variables var theCookie =3D document.cookie; var today =3D new Date(); var expDate =3D new Date(); // Check if user has visited page before if (theCookie.indexOf(svyName) =3D=3D -1) { =20 expDate =3D whenIs(today, expire); expDate =3D expDate.toGMTString(); document.cookie =3D svyName + "; path=3D/; expires=3D" + expDate + = ";"; window.open(inviteurl, "", "toolbar=3Dno,status=3Dno,width=3D" + = frmWidth + ",height=3D" + frmHeight + ",top=3D150,left=3D50"); //window.open(surveyurl, "", = "toolbar=3Dno,status=3Dno,width=3D270,height=3D220,top=3D150,left=3D50");= } } function invite(inviteurl,frmWidth,frmHeight,svyName,expire,path) { //******************************************************************** // Display invitation if specific cookie not found and set cookie // Parameters // inviteurl: URL of invite form // frmWidth & frmHeight: dimensions of invitation window // svyName: Name of the specific survey // expire: Number of days before cookie expires // path: cookie path //=20 // Created by Chris Miceli 2/25/2004 //******************************************************************** // define variables var theCookie =3D document.cookie; var today =3D new Date(); var expDate =3D new Date(); // Check if user has visited page before if (readCookie(svyName) =3D=3D null) { =09 createCookie(svyName, svyName, expire); window.open(inviteurl, "", "toolbar=3Dno,status=3Dno,width=3D" + = frmWidth + ",height=3D" + frmHeight + ",top=3D150,left=3D50"); } } function whenIs(anyDate, n){ //-- Returns the date that is n days from any date. var newDate =3D new Date(); newDate.setTime(anyDate.getTime()+(n*1000*60*60*24)); return newDate; } //******************************************************************** // Display invitation if specific cookie not found and set cookie // Parameters // Display invitation every nthe hit on page, every 5th customer or = every 163rd customer. =20 // Created by SFungafat , Modified RKumar June 2004 //******************************************************************** function intercept(surveyurl) { // define variables var cookie_ls =3D document.cookie; var date_ls =3D new Date(); var S =3D new Date(); // if not yet sampled if (cookie_ls.indexOf("NEJM062004WEB") =3D=3D -1) { rnd.today=3Dnew Date(); rnd.seed=3Drnd.today.getTime(); =20 function whenIs(anyDate, n){ //-- Returns the date that is n days from any date. var newDate =3D new Date(); = newDate.setTime(anyDate.getTime()+(n*1000*60*60*24)); return newDate; } function rnd() { rnd.seed =3D (rnd.seed*9301+49297) % 233280; return rnd.seed/(233280.0); }; function rand(number) { return Math.ceil(rnd()*number); }; =20 sample=3Drand(5); // for the sample grab 1 in 5 if (sample=3D=3D5) { S =3D whenIs(date_ls, 3); S =3D S.toGMTString(); document.cookie =3D "NEJM062004WEB; path=3D/; expires=3D" + = S + ";"; window.open(surveyurl, "", = "toolbar=3Dno,status=3Dno,width=3D600,height=3D300,top=3D150,left=3D50") } } } //************************************************ // Set pop-up cookie based on country and IP type // Parameters // country: two character country code // instFlag: NEJM Institution, 1=3DTrue, 0=3DFalse // ** Use ISO 3166 standard 2-letter country codes ** //************************************************ function intlSurvey(country, instFlag) { var validCtys =3D "JP"; if (cookiesAreEnabled()) { country =3D country.toUpperCase() =09 // Invite only displayed for valid countries if (country.indexOf(validCtys) > -1) { if (instFlag =3D=3D 1) { //Set cookie one day for NEJM Institutions = invite('http://survey.nejm.org/NEJMJPN/popup.aspx',510,260,'NEJMESINST',1= , 'nejm.org'); } else { //60 days for all others = invite('http://survey.nejm.org/NEJMJPN/popup.aspx',510,260,'NEJMESNONINST= ',45, 'nejm.org'); } =09 } } } //************************************************ // Set pop-up cookie based on country.=20 // Parameters // userCty: Country user from // validCty: Country or countries to test against // inviteurl: URL of invite form // svyName: Name of the specific survey // expire: Number of days before cookie expires // frmWidth & frmHeight: dimensions of invitation window //************************************************ function surveyByCty(userCty, validCty, inviteurl, svyName, expire, = frmWidth, frmHeight) { if (cookiesAreEnabled()) { userCty =3D userCty.toUpperCase() validCty =3D validCty.toUpperCase() =09 // Invite only displayed for valid countries if (userCty.indexOf(validCty) > -1) { //Display invite invite(inviteurl, frmWidth, frmHeight, svyName, expire); } } } // Checks if cookies are enabled in browser. function cookiesAreEnabled() { setCookie( "foo", "bar" ); if ( getCookie( "foo" ) ) { deleteCookie( "foo" ); return true; } else { return false; } } function setCookie( name, value, expires, path, domain, secure ) { document.cookie =3D name + "=3D" + escape (value) + ( ( expires ) ? "; expires=3D" + expires : "" ) + ( ( path ) ? "; path=3D" + path : "" ) + ( ( domain ) ? "; domain=3D" + domain : "" ) + ( ( secure ) ? "; secure" : "" ); } function getCookie( name ) { var arg =3D name + "=3D"; var alen =3D arg.length; var clen =3D document.cookie.length; var i =3D 0; while ( i < clen ) { var j =3D i + alen; if ( document.cookie.substring(i, j) =3D=3D arg ) return = getCookieVal(j); i =3D document.cookie.indexOf( " ", i ) + 1; if ( i =3D=3D 0 ) break; } return null; } /** * Helper function for getCookie() */ function getCookieVal( offset ) { var endstr =3D document.cookie.indexOf ( ";", offset ); if ( endstr =3D=3D -1 ) endstr =3D document.cookie.length; return unescape( document.cookie.substring( offset, endstr ) ); } function deleteCookie( name, path, domain ) { if ( getCookie( name ) ) { document.cookie =3D name + "=3D" + ( ( path ) ? "; path=3D" + path : "" ) + ( ( domain ) ? "; domain=3D" + domain : "" ) + "; expires=3DThu, 01-Jan-70 00:00:01 GMT"; } } function createCookie(name, value, days) { if (days) { var date =3D new Date; date.setTime(date.getTime() + days * 24 * 60 * 60 * 1000); var expires =3D "; expires=3D" + date.toGMTString(); } else { var expires =3D ""; } document.cookie =3D name + "=3D" + value + expires + "; path=3D/" } function readCookie(name) { var nameEQ =3D name + "=3D"; var ca =3D document.cookie.split(";"); for (var i =3D 0; i < ca.length; i++) { var c =3D ca[i]; while (c.charAt(0) =3D=3D " ") { c =3D c.substring(1, c.length); } if (c.indexOf(nameEQ) =3D=3D 0) { return c.substring(nameEQ.length, c.length); } } return null; } ------=_NextPart_000_0031_01C8A1F4.497E8660--