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

NCT02106832 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 156262013-004659-19
• Study Type: interventional
• Target: 521
• Locations: 24 countries
• Sites: 200

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 (2)

• Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo

  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

• Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo

  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

Subjects 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 (BAYQ3939) dry powder for inhalation

Ciprofloxacin DPI 14 Days on/off (Cipro 14)

EXPERIMENTAL

Subjects 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 (BAYQ3939) dry powder for inhalation

Placebo 28 Days on/off (Placebo 28)

PLACEBO COMPARATOR

Subjects 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

Subjects 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 (BAYQ3939) dry powder for inhalation DRUG

Ciprofloxacin dry powder for inhalation (DPI) 32.5 mg inhaled twice daily in cycles of 28 days on-treatment and 28 days off-treatment.

Ciprofloxacin DPI 28 Days on/off (Cipro 28)

Placebo DRUG

Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off

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 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 (207)

Unknown Facility

Peoria, Arizona, 85381, United States

Location

Unknown Facility

Fountain Valley, California, 90708, United States

Location

Unknown Facility

La Jolla, California, 92037, United States

Location

Unknown Facility

Long Beach, California, 90813, United States

Location

Unknown Facility

Newport Beach, California, 92663, United States

Location

Unknown Facility

San Diego, California, 92120, United States

Location

Unknown Facility

Kissimmee, Florida, 34741, United States

Location

Unknown Facility

Miami, Florida, 33126, United States

Location

Unknown Facility

Sarasota, Florida, 34239, United States

Location

Unknown Facility

Tampa, Florida, 33613, United States

Location

Unknown Facility

Decatur, Georgia, 30033, United States

Location

Unknown Facility

Skokie, Illinois, 60076, United States

Location

Unknown Facility

Olathe, Kansas, 66061, United States

Location

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

Brooklyn, New York, 11229, United States

Location

Unknown Facility

Mineola, New York, 11501, United States

Location

Unknown Facility

Asheville, North Carolina, 28801, United States

Location

Unknown Facility

Portland, Oregon, 97239, United States

Location

Unknown Facility

Doylestown, Pennsylvania, 18901, United States

Location

Unknown Facility

Greenville, South Carolina, 29615, United States

Location

Unknown Facility

Edinburg, Texas, 78539, United States

Location

Unknown Facility

Tyler, Texas, 75708-3154, United States

Location

Unknown Facility

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

Location

Unknown Facility

Capital Federal, Ciudad Auton. de Buenos Aires, 1425, Argentina

Location

Unknown Facility

Godoy Cruz, Mendoza Province, 5501, Argentina

Location

Unknown Facility

Córdoba, X5003DCE, Argentina

Location

Unknown Facility

Vicente López, 1638, Argentina

Location

Unknown Facility

Kogarah, New South Wales, 2217, Australia

Location

Unknown Facility

New Lambton Heights, New South Wales, 2305, Australia

Location

Unknown Facility

Adelaide, South Australia, 5041, Australia

Location

Unknown Facility

Adelaide, South Australia, 5042, Australia

Location

Unknown Facility

Parkville, Victoria, 3050, Australia

Location

Unknown Facility

Murdoch, Western Australia, 6150, Australia

Location

Unknown Facility

Perth, Western Australia, 6009, Australia

Location

Unknown Facility

Graz, 8036, Austria

Location

Unknown Facility

Salzburg, 5020, Austria

Location

Unknown Facility

Belo Horizonte, Minas Gerais, 30150-221, Brazil

Location

Unknown Facility

Recife, Pernambuco, 50920640, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, 90880-480, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 04266-010, Brazil

Location

Unknown Facility

Porto Alegre, 90035-074, Brazil

Location

Unknown Facility

São Paulo, 01244-030, Brazil

Location

Unknown Facility

São Paulo, 05403-900, Brazil

Location

Unknown Facility

Gabrovo, 5300, Bulgaria

Location

Unknown Facility

Kozloduy, 3320, Bulgaria

Location

Unknown Facility

Lovech, 5500, Bulgaria

Location

Unknown Facility

Razgrad, 7200, Bulgaria

Location

Unknown Facility

Rousse, 7000, Bulgaria

Location

Unknown Facility

Sevlievo, 5400, Bulgaria

Location

Unknown Facility

Sliven, 8800, Bulgaria

Location

Unknown Facility

Sofia, 1000, Bulgaria

Location

Unknown Facility

Sofia, 1606, Bulgaria

Location

Unknown Facility

Stara Zagora, 6000, Bulgaria

Location

Unknown Facility

Fuzhou, Fujian, 350025, China

Location

Unknown Facility

Guangzhou, Guangdong, 510120, China

Location

Unknown Facility

Hohehot, Inner Mongolia, 010050, China

Location

Unknown Facility

Suzhou, Jiangsu, 215006, China

Location

Unknown Facility

Wuxi, Jiangsu, 214023, China

Location

Unknown Facility

Nanchang, Jiangxi, 330006, China

Location

Unknown Facility

Shenyang, Liaoning, 110004, China

Location

Unknown Facility

Yinchuan, Ningxia, 750004, China

Location

Unknown Facility

Chengdu, Sichuan, 610041, China

Location

Unknown Facility

Beijing, 100029, China

Location

Unknown Facility

Beijing, 100144, China

Location

Unknown Facility

Chongqing, 400042, China

Location

Unknown Facility

Shanghai, 200032, China

Location

Unknown Facility

Shanghai, 200040, China

Location

Unknown Facility

Shanghai, 200433, China

Location

Unknown Facility

Brno, 625 00, Czechia

Location

Unknown Facility

Prague, 121 11, Czechia

Location

Unknown Facility

Prague, 140 46, Czechia

Location

Unknown Facility

Prague, 180 81, Czechia

Location

Unknown Facility

Treuenbrietzen, Brandenburg, 14929, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, 60389, Germany

Location

Unknown Facility

Neu-Isenburg, Hesse, 63263, Germany

Location

Unknown Facility

Hanover, Lower Saxony, 30173, Germany

Location

Unknown Facility

Hanover, Lower Saxony, 30625, Germany

Location

Unknown Facility

Gelsenkirchen, North Rhine-Westphalia, 45879, Germany

Location

Unknown Facility

Leipzig, Saxony, 04357, Germany

Location

Unknown Facility

Bad Berka, Thuringia, 99437, Germany

Location

Unknown Facility

Jena, Thuringia, 07740, Germany

Location

Unknown Facility

Berlin, 10717, Germany

Location

Unknown Facility

Berlin, 14059, Germany

Location

Unknown Facility

Hamburg, 22767, Germany

Location

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Kowloon, Hong Kong

Location

Unknown Facility

New Territories, Hong Kong

Location

Unknown Facility

Shatin, Hong Kong

Location

Unknown Facility

Daugavpils, LV-5403, Latvia

Location

Unknown Facility

Daugavpils, LV-5410, Latvia

Location

Unknown Facility

Jūrmala, LV-2010, Latvia

Location

Unknown Facility

Krāslava, 5601, Latvia

Location

Unknown Facility

Riga, LV-1001, Latvia

Location

Unknown Facility

Riga, LV-1002, Latvia

Location

Unknown Facility

Riga, LV-1011, Latvia

Location

Unknown Facility

Riga, LV-1038, Latvia

Location

Unknown Facility

Talsi, LV-3201, Latvia

Location

Unknown Facility

Klaipėda, LT-92288, Lithuania

Location

Unknown Facility

Vilnius, LT-08661, Lithuania

Location

Unknown Facility

Alkmaar, 1815 JD, Netherlands

Location

Unknown Facility

Assen, 9403 RK, Netherlands

Location

Unknown Facility

Groningen, 9728 NT, Netherlands

Location

Unknown Facility

Helmond, 5707 HA, Netherlands

Location

Unknown Facility

Maastricht, 6229 HX, Netherlands

Location

Unknown Facility

Sittard-Geleen, 6162 BG, Netherlands

Location

Unknown Facility

Veldhoven, 5500 MB, Netherlands

Location

Unknown Facility

City of San Fernando, 2000, Philippines

Location

Unknown Facility

Manila, 1000, Philippines

Location

Unknown Facility

Manila, 1012, Philippines

Location

Unknown Facility

Quezon City, NCR 1100, Philippines

Location

Unknown Facility

Quezon City, NCR 1104, Philippines

Location

Unknown Facility

Bielsko-Biala, 43-300, Poland

Location

Unknown Facility

Częstochowa, 42-200, Poland

Location

Unknown Facility

Gorzów Wielkopolski, 66-400, Poland

Location

Unknown Facility

Grudziądz, 86-300, Poland

Location

Unknown Facility

Katowice, 40-954, Poland

Location

Unknown Facility

Kielce, 25-035, Poland

Location

Unknown Facility

Kielce, 25-734, Poland

Location

Unknown Facility

Kielce, 25-751, Poland

Location

Unknown Facility

Krakow, 31-455, Poland

Location

Unknown Facility

Ksawerów, 95-054, Poland

Location

Unknown Facility

Mrozy, 05-320, Poland

Location

Unknown Facility

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Unknown Facility

Rzeszów, 35-301, Poland

Location

Unknown Facility

Warsaw, 01-868, Poland

Location

Unknown Facility

Angra do Heroísmo, Azores, 9701-856, Portugal

Location

Unknown Facility

Vila Nova de Gaia, Porto District, 4434-502, Portugal

Location

Unknown Facility

Faro, 8000-386, Portugal

Location

Unknown Facility

Lisbon, 1649-035, Portugal

Location

Unknown Facility

Lisbon, 1769-001, Portugal

Location

Unknown Facility

Bragadiru, 077025, Romania

Location

Unknown Facility

Brasov, 500086, Romania

Location

Unknown Facility

Bucharest, 010457, Romania

Location

Unknown Facility

Bucharest, 011461, Romania

Location

Unknown Facility

Bucharest, 030303, Romania

Location

Unknown Facility

Bucharest, 050159, Romania

Location

Unknown Facility

Codlea, 505100, Romania

Location

Unknown Facility

Constanța, 900002, Romania

Location

Unknown Facility

Iași, 700141, Romania

Location

Unknown Facility

Ploieşti, 100184, Romania

Location

Unknown Facility

Timișoara, 300310, Romania

Location

Unknown Facility

Arkhangelsk, 163001, Russia

Location

Unknown Facility

Chelyabinsk, 454076, Russia

Location

Unknown Facility

Moscow, 105229, Russia

Location

Unknown Facility

Moscow, 115682, Russia

Location

Unknown Facility

Moscow, 127015, Russia

Location

Unknown Facility

Moscow, 129090, Russia

Location

Unknown Facility

Nizhny Novgorod, 603035, Russia

Location

Unknown Facility

Novosibirsk, 630047, Russia

Location

Unknown Facility

Novosibirsk, 630075, Russia

Location

Unknown Facility

Novosibirsk, 630087, Russia

Location

Unknown Facility

Saint Petersburg, 194295, Russia

Location

Unknown Facility

Saint Petersburg, 194356, Russia

Location

Unknown Facility

Saint Petersburg, 196084, Russia

Location

Unknown Facility

Tomsk, 634063, Russia

Location

Unknown Facility

Ufa, 450071, Russia

Location

Unknown Facility

Voronezh, 394066, Russia

Location

Unknown Facility

Yaroslavl, 150003, Russia

Location

Unknown Facility

Belgrade, 11000, Serbia

Location

Unknown Facility

Belgrade, 11080, Serbia

Location

Unknown Facility

Čačak, 32000, Serbia

Location

Unknown Facility

Kamenitz, 21204, Serbia

Location

Unknown Facility

Knez-Selo, 18204, Serbia

Location

Unknown Facility

Kragujevac, 34000, Serbia

Location

Unknown Facility

Sombor, 25000, Serbia

Location

Unknown Facility

Valjevo, 14000, Serbia

Location

Unknown Facility

Bratislava, 821 06, Slovakia

Location

Unknown Facility

Prešov, 080 01, Slovakia

Location

Unknown Facility

Johannesburg, Gauteng, 2092, South Africa

Location

Unknown Facility

eManzimtoti, KwaZulu-Natal, 4127, South Africa

Location

Unknown Facility

Cape Town, Western Cape, 7500, South Africa

Location

Unknown Facility

Cape Town, Western Cape, 7764, South Africa

Location

Unknown Facility

Daejeon, Daejeon Gwang''yeogsi, 301-723, South Korea

Location

Unknown Facility

Bucheon-si, Gyeonggido, 420-717, South Korea

Location

Unknown Facility

Incheon Gwangyeogsi,, Incheon Gwang''yeogsi, 403-720, South Korea

Location

Unknown Facility

Seoul, Seoul Teugbyeolsi, 135-720, South Korea

Location

Unknown Facility

Daegu, 42415, South Korea

Location

Unknown Facility

Incheon, 21565, South Korea

Location

Unknown Facility

Seoul, 03080, South Korea

Location

Unknown Facility

Seoul, 100-032, South Korea

Location

Unknown Facility

Seoul, 120-752, South Korea

Location

Unknown Facility

Seoul, 130-872, South Korea

Location

Unknown Facility

Seoul, 136-705, South Korea

Location

Unknown Facility

Chiayi City, 613, Taiwan

Location

Unknown Facility

Kaohsiung City, 807, Taiwan

Location

Unknown Facility

New Taipei City, 23561, Taiwan

Location

Unknown Facility

Taichung, 40447, Taiwan

Location

Unknown Facility

Taipei, 10002, Taiwan

Location

Unknown Facility

Bangkok, 10400, Thailand

Location

Unknown Facility

Bangkok, 10700, Thailand

Location

Unknown Facility

Chiang Mai, 50200, Thailand

Location

Unknown Facility

Khon Kaen, 40002, Thailand

Location

Unknown Facility

NakhonRatchasima, 30000, Thailand

Location

Unknown Facility

Phitsanulok, 65000, Thailand

Location

Unknown Facility

Udon Thani, 41000, Thailand

Location

Unknown Facility

Ankara, 061100, Turkey (Türkiye)

Location

Unknown Facility

Ankara, 06110, Turkey (Türkiye)

Location

Unknown Facility

Balcalı, 01330, Turkey (Türkiye)

Location

Unknown Facility

Izmir, 35040, Turkey (Türkiye)

Location

Unknown Facility

Kampus, 07058, Turkey (Türkiye)

Location

Unknown Facility

Konya, 42080, Turkey (Türkiye)

Location

Unknown Facility

Maltepe, 34844, Turkey (Türkiye)

Location

Unknown Facility

Mersin, 33343, Turkey (Türkiye)

Location

Unknown Facility

Pendik, 34890, Turkey (Türkiye)

Location

Unknown Facility

Samsun, 55139, Turkey (Türkiye)

Location

Unknown Facility

Şehitkamil, 27310, Turkey (Türkiye)

Location

Related Publications (2)

• Aksamit T, De Soyza A, Bandel TJ, Criollo M, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. RESPIRE 2: 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):1702053. doi: 10.1183/13993003.02053-2017. Print 2018 Jan.

  PMID: 29371384 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

Interventions

Ciprofloxacin; Inhalation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

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: April 4, 2014
• First Posted: April 8, 2014
• Study Start: April 30, 2014
• Primary Completion: September 13, 2016
• Study Completion: October 19, 2016
• Last Updated: October 2, 2017
• Results First Posted: September 1, 2017

Record last verified: 2017-09

Locations

BU (10); KR (11); TW (5); TH (7); DE (12); US (22); BR (8); AU (2); CN (15); AR (5); HK (4); ZA (4); NL (7); PH (5); LI (2); SE (8); LA (9); RO (11); SL (2); PL (14); PT (5); CZ (4); RU (17); TU (11)