Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)

NCT01764841 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 156252011-004208-39
• Study Type: interventional
• Target: 416
• Locations: 14 countries
• Sites: 151

Brief Summary

The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.

Conditions

Bronchiectasis

Keywords

Ciprofloxacin; Dry Powder for Inhalation; Exacerbation; Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Time to First Exacerbation Event Within 48 Weeks

  Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.

  Up to Week 48

Secondary Outcomes (7)

• Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks

  Up to Week 48

• Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks

  Up to Week 48

• Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)

  End of treatment (Week 44/46)

• Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)

  Baseline and end of treatment (Week 44/46)

• Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)

  End of treatment (Week 44/46)

Study Arms (4)

Ciprofloxacin DPI 28 Days on/off (Cipro 28)

EXPERIMENTAL

Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).

Drug: Ciprofloxacin DPI (BAYQ3939)

Ciprofloxacin DPI 14 Days on/off (Cipro 14)

EXPERIMENTAL

Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).

Drug: Ciprofloxacin DPI (BAYQ3939)

Placebo 28 Days on/off (Placebo 28)

PLACEBO COMPARATOR

Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).

Drug: Placebo

Placebo 14 Days on/off (Placebo 14)

PLACEBO COMPARATOR

Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).

Drug: Placebo

Interventions

Ciprofloxacin DPI (BAYQ3939) DRUG

Participants received 32.5 mg ciprofloxacin hydrated (corresponding to 50 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device.

Ciprofloxacin DPI 14 Days on/off (Cipro 14); Ciprofloxacin DPI 28 Days on/off (Cipro 28)

Placebo DRUG

Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device.

Placebo 14 Days on/off (Placebo 14); Placebo 28 Days on/off (Placebo 28)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a proven and documented diagnosis of non Cystic Fibrosis (CF) idiopathic or post infectious bronchiectasis
• Stable pulmonary status and stable regimen of standard treatment at least for the past 4 weeks

You may not qualify if:

• Forced expiratory volume in 1 second (FEV1) \<30% or \>90% predicted
• Active allergic bronchopulmonary aspergillosis
• Active and actively treated non tuberculosis mycobacterial (NTM) infection or tuberculosis
• Primary diagnosis of Chronic obstructive pulmonary disease (COPD)

Sponsors & Collaborators

• Bayer: lead
• Novartis: collaborator

Study Sites (151)

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Jasper, Alabama, 35501, United States

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Flagstaff, Arizona, 86001, United States

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Phoenix, Arizona, 85006-2611, United States

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Scottsdale, Arizona, 85258, United States

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Fort Smith, Arkansas, 72901, United States

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Los Angeles, California, 90048, United States

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Torrance, California, United States

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Ventura, California, 93003, United States

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Farmington, Connecticut, 06030, United States

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Waterbury, Connecticut, 06708-2513, United States

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Washington D.C., District of Columbia, 20007-2197, United States

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Celebration, Florida, 34747, United States

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Miami, Florida, 33136, United States

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Orlando, Florida, 32803, United States

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Weston, Florida, 33331, United States

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Winter Park, Florida, 32789, United States

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Lawrenceville, Georgia, 30046, United States

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Marietta, Georgia, 30060, United States

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Chicago, Illinois, 60637, United States

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Michigan City, Indiana, 46360, United States

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Hazard, Kentucky, 41701, United States

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Chesterfield, Missouri, 63017, United States

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Summit, New Jersey, 07901, United States

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New Hyde Park, New York, 11042, United States

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New York, New York, 10016, United States

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Portland, Oregon, 97239-3011, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19140, United States

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Charleston, South Carolina, 29425, United States

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Fort Worth, Texas, 76104, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77043, United States

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Kingwood, Texas, 77339, United States

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McKinney, Texas, 75069, United States

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Tyler, Texas, 75708-3154, United States

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Abingdon, Virginia, 24210, United States

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Richmond, Virginia, 23225, United States

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Spokane, Washington, 99202-1334, United States

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Tacoma, Washington, 98405, United States

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Buenos Aires, Ciudad Auton. de Buenos Aires, C1425DES, Argentina

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Godoy Cruz, Mendoza Province, 5501, Argentina

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Vicente López, 1638, Argentina

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Woolloongabba, Queensland, 4102, Australia

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Adelaide, South Australia, 5000, Australia

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Adelaide, South Australia, 5041, Australia

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Woodville, South Australia, 5011, Australia

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Parkville, Victoria, 3050, Australia

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Prahran, Victoria, 3181, Australia

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Murdoch, Western Australia, 6150, Australia

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Box Hill, 3128, Australia

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Cairns, 4870, Australia

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Frankston, 3199, Australia

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Kogarah, 2217, Australia

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Toorak Gardens, 5065, Australia

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Aarhus C, 8000, Denmark

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Hellerup, 2900, Denmark

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Næstved, 4700, Denmark

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Roskilde, 4000, Denmark

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Clermont-Ferrand, 63000, France

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Montpellier, 34059, France

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Nîmes, 30900, France

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Toulon, 83000, France

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Heidelberg, Baden-Wurttemberg, 69126, Germany

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Cottbus, Brandenburg, 03050, Germany

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Frankfurt am Main, Hesse, 60389, Germany

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Neu-Isenburg, Hesse, 63263, Germany

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Hanover, Lower Saxony, 30173, Germany

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Hanover, Lower Saxony, 30625, Germany

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Koblenz, Rhineland-Palatinate, 56068, Germany

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Geesthacht, Schleswig-Holstein, 21502, Germany

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Jena, Thuringia, 07740, Germany

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Berlin, 10717, Germany

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Berlin, 10969, Germany

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Berlin, 12203, Germany

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Hamburg, 22767, Germany

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Afula, 1834111, Israel

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Ashkelon, 7827804, Israel

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Beersheba, 8410101, Israel

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Haifa, 3109601, Israel

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Haifa, 3436212, Israel

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Jerusalem, 9112001, Israel

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Petah Tikva, 4941492, Israel

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Ramat Gan, 5262000, Israel

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Rehovot, 7610001, Israel

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Tel Aviv, 6423906, Israel

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Bari, Apulia, 70020, Italy

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Benevento, Campania, 82037, Italy

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Trieste, Friuli Venezia Giulia, 34149, Italy

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Rome, Lazio, 00168, Italy

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Pavia, Lombardy, 27040, Italy

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Varese, Lombardy, 21049, Italy

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Cagliari, Sardinia, 09126, Italy

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Catania, Sicily, 95123, Italy

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Pisa, Tuscany, 56124, Italy

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Verona, Veneto, 37126, Italy

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Tōon, Ehime, 791-0281, Japan

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Nakagun, Ibaraki, 319-1113, Japan

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Kōshi, Kumamoto, 861-1196, Japan

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Matsusaka, Mie-ken, 515-8544, Japan

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Tsu, Mie-ken, 514-1101, Japan

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Sakai, Osaka, 591-8555, Japan

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Hamamatsu, Shizuoka, 434-8511, Japan

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Kiyose, Tokyo, 204-8585, Japan

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Mitaka, Tokyo, 181-8611, Japan

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Fukuoka, 811-1394, Japan

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Daugavpils, LV-5403, Latvia

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Daugavpils, LV-5410, Latvia

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Jūrmala, LV-2010, Latvia

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Krāslava, 5601, Latvia

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Riga, LV-1001, Latvia

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Riga, LV-1002, Latvia

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Riga, LV-1011, Latvia

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Riga, LV-1038, Latvia

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Talsu, 3201, Latvia

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Auckland, 1051, New Zealand

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Auckland, 1640, New Zealand

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Christchurch, 8011, New Zealand

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Dunedin, New Zealand

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Hamilton, 3240, New Zealand

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Tauranga, 3110, New Zealand

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Wellington, 6021, New Zealand

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Bratislava, 821 06, Slovakia

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Prešov, 080 01, Slovakia

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Santiago de Compostela, A Coruña, 15706, Spain

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Elda, Alicante, 03600, Spain

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Badalona, Barcelona, 08916, Spain

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Sant Boi de Llobregat, Barcelona, 08830, Spain

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Terrassa, Barcelona, 08221, Spain

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Pozuelo de Alarcón, Madrid, 28223, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Barcelona, 08036, Spain

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Barcelona, 08041, Spain

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Cáceres, 10003, Spain

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Madrid, 28006, Spain

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Madrid, 28034, Spain

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Madrid, 28040, Spain

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Pontevedra, 36071, Spain

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Valencia, 46017, Spain

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Valencia, 46026, Spain

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Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

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Exeter, Devon, EX2 5DW, United Kingdom

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Plymouth, Devon, PL6 8DH, United Kingdom

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Torbay, Devon, TQ2 7AA, United Kingdom

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Dundee, Dundee City, DD1 9SY, United Kingdom

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Belfast, North Ireland, BT12 7AB, United Kingdom

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Shrewsbury, Shropshire, SY3 8XQ, United Kingdom

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Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

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London, SW3 6NP, United Kingdom

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Londonderry, BT47 6SB, United Kingdom

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Manchester, M23 9LT, United Kingdom

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Related Publications (2)

• De Soyza A, Aksamit T, Bandel TJ, Criollo M, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J. 2018 Jan 25;51(1):1702052. doi: 10.1183/13993003.02052-2017. Print 2018 Jan.

  PMID: 29371383 DERIVED

• Aksamit T, Bandel TJ, Criollo M, De Soyza A, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. The RESPIRE trials: Two phase III, randomized, multicentre, placebo-controlled trials of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in non-cystic fibrosis bronchiectasis. Contemp Clin Trials. 2017 Jul;58:78-85. doi: 10.1016/j.cct.2017.05.007. Epub 2017 May 8.

  PMID: 28495619 DERIVED

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayer.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 10, 2013
• Study Start: May 2, 2013
• Primary Completion: March 9, 2016
• Study Completion: March 9, 2016
• Last Updated: January 24, 2018
• Results First Posted: May 24, 2017

Record last verified: 2018-01

Locations

GB (11); ES (17); JP (10); AR (3); DK (4); AU (12); FR (4); DE (13); LA (9); NZ (7); IL (10); SL (2); US (39); IT (10)