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BronchiectasisPhase 3RESPIRE 1NCT01764841

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

A Phase 3 study testing Ciprofloxacin DPI (BAYQ3939) in people with Bronchiectasis, run by Bayer at 151 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bronchiectasis
What is being tested?
Ciprofloxacin DPI (BAYQ3939)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
416 participants
Where
151 sitesin 14 countries
Study dates
2 May 2013to 9 Mar 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

151 sites in 14 countries.

151 sites in 14 countries

United States39 sites

  • Study site

    Abingdon, Virginia, 24210

  • Study site

    Celebration, Florida, 34747

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Chesterfield, Missouri, 63017

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Farmington, Connecticut, 06030

  • Study site

    Flagstaff, Arizona, 86001

  • Study site

    Fort Smith, Arkansas, 72901

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Hazard, Kentucky, 41701

  • Study site

    Houston, Texas, 77030

  • Study site

    Houston, Texas, 77043

  • Study site

    Jasper, Alabama, 35501

  • Study site

    Kingwood, Texas, 77339

  • Study site

    Lawrenceville, Georgia, 30046

  • Study site

    Los Angeles, California, 90048

  • Study site

    Marietta, Georgia, 30060

  • Study site

    McKinney, Texas, 75069

  • Study site

    Miami, Florida, 33136

  • Study site

    Michigan City, Indiana, 46360

  • Study site

    New Hyde Park, New York, 11042

  • Study site

    New York, New York, 10016

  • Study site

    Orlando, Florida, 32803

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Philadelphia, Pennsylvania, 19140

  • Study site

    Phoenix, Arizona, 85006-2611

  • Study site

    Portland, Oregon, 97239-3011

  • Study site

    Richmond, Virginia, 23225

  • Study site

    Scottsdale, Arizona, 85258

  • Study site

    Spokane, Washington, 99202-1334

  • Study site

    Summit, New Jersey, 07901

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Torrance, California

  • Study site

    Tyler, Texas, 75708-3154

  • Study site

    Ventura, California, 93003

  • Study site

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

  • Study site

    Waterbury, Connecticut, 06708-2513

  • Study site

    Weston, Florida, 33331

  • Study site

    Winter Park, Florida, 32789

Other trials in United States

Spain17 sites

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Barcelona, 08036

  • Study site

    Barcelona, 08041

  • Study site

    Cáceres, 10003

  • Study site

    Elda, Alicante, 03600

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Madrid, 28006

  • Study site

    Madrid, 28034

  • Study site

    Madrid, 28040

  • Study site

    Oviedo, Principality of Asturias, 33006

  • Study site

    Pontevedra, 36071

  • Study site

    Pozuelo de Alarcón, Madrid, 28223

  • Study site

    Sant Boi de Llobregat, Barcelona, 08830

  • Study site

    Santiago de Compostela, A Coruña, 15706

  • Study site

    Terrassa, Barcelona, 08221

  • Study site

    Valencia, 46017

  • Study site

    Valencia, 46026

Other trials in Spain

Germany13 sites

  • Study site

    Berlin, 10717

  • Study site

    Berlin, 10969

  • Study site

    Berlin, 12203

  • Study site

    Cottbus, Brandenburg, 03050

  • Study site

    Frankfurt am Main, Hesse, 60389

  • Study site

    Geesthacht, Schleswig-Holstein, 21502

  • Study site

    Hamburg, 22767

  • Study site

    Hanover, Lower Saxony, 30173

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Heidelberg, Baden-Wurttemberg, 69126

  • Study site

    Jena, Thuringia, 07740

  • Study site

    Koblenz, Rhineland-Palatinate, 56068

  • Study site

    Neu-Isenburg, Hesse, 63263

Other trials in Germany

Australia12 sites

  • Study site

    Adelaide, South Australia, 5000

  • Study site

    Adelaide, South Australia, 5041

  • Study site

    Box Hill, 3128

  • Study site

    Cairns, 4870

  • Study site

    Frankston, 3199

  • Study site

    Kogarah, 2217

  • Study site

    Murdoch, Western Australia, 6150

  • Study site

    Parkville, Victoria, 3050

  • Study site

    Prahran, Victoria, 3181

  • Study site

    Toorak Gardens, 5065

  • Study site

    Woodville, South Australia, 5011

  • Study site

    Woolloongabba, Queensland, 4102

Other trials in Australia

United Kingdom11 sites

  • Study site

    Belfast, North Ireland, BT12 7AB

  • Study site

    Cambridge, Cambridgeshire, CB23 3RE

  • Study site

    Dundee, Dundee City, DD1 9SY

  • Study site

    Exeter, Devon, EX2 5DW

  • Study site

    London, SW3 6NP

  • Study site

    Londonderry, BT47 6SB

  • Study site

    Manchester, M23 9LT

  • Study site

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN

  • Study site

    Plymouth, Devon, PL6 8DH

  • Study site

    Shrewsbury, Shropshire, SY3 8XQ

  • Study site

    Torbay, Devon, TQ2 7AA

Other trials in United Kingdom

Israel10 sites

  • Study site

    Afula, 1834111

  • Study site

    Ashkelon, 7827804

  • Study site

    Beersheba, 8410101

  • Study site

    Haifa, 3109601

  • Study site

    Haifa, 3436212

  • Study site

    Jerusalem, 9112001

  • Study site

    Petah Tikva, 4941492

  • Study site

    Ramat Gan, 5262000

  • Study site

    Rehovot, 7610001

  • Study site

    Tel Aviv, 6423906

Other trials in Israel

Italy10 sites

  • Study site

    Bari, Apulia, 70020

  • Study site

    Benevento, Campania, 82037

  • Study site

    Cagliari, Sardinia, 09126

  • Study site

    Catania, Sicily, 95123

  • Study site

    Pavia, Lombardy, 27040

  • Study site

    Pisa, Tuscany, 56124

  • Study site

    Rome, Lazio, 00168

  • Study site

    Trieste, Friuli Venezia Giulia, 34149

  • Study site

    Varese, Lombardy, 21049

  • Study site

    Verona, Veneto, 37126

Other trials in Italy

Japan10 sites

  • Study site

    Fukuoka, 811-1394

  • Study site

    Hamamatsu, Shizuoka, 434-8511

  • Study site

    Kiyose, Tokyo, 204-8585

  • Study site

    Kōshi, Kumamoto, 861-1196

  • Study site

    Matsusaka, Mie-ken, 515-8544

  • Study site

    Mitaka, Tokyo, 181-8611

  • Study site

    Nakagun, Ibaraki, 319-1113

  • Study site

    Sakai, Osaka, 591-8555

  • Study site

    Tōon, Ehime, 791-0281

  • Study site

    Tsu, Mie-ken, 514-1101

Other trials in Japan

Latvia9 sites

  • Study site

    Daugavpils, LV-5403

  • Study site

    Daugavpils, LV-5410

  • Study site

    Jūrmala, LV-2010

  • Study site

    Krāslava, 5601

  • Study site

    Riga, LV-1001

  • Study site

    Riga, LV-1002

  • Study site

    Riga, LV-1011

  • Study site

    Riga, LV-1038

  • Study site

    Talsu, 3201

Other trials in Latvia

New Zealand7 sites

  • Study site

    Auckland, 1051

  • Study site

    Auckland, 1640

  • Study site

    Christchurch, 8011

  • Study site

    Dunedin

  • Study site

    Hamilton, 3240

  • Study site

    Tauranga, 3110

  • Study site

    Wellington, 6021

Other trials in New Zealand

Denmark4 sites

  • Study site

    Aarhus C, 8000

  • Study site

    Hellerup, 2900

  • Study site

    Næstved, 4700

  • Study site

    Roskilde, 4000

Other trials in Denmark

France4 sites

  • Study site

    Clermont-Ferrand, 63000

  • Study site

    Montpellier, 34059

  • Study site

    Nîmes, 30900

  • Study site

    Toulon, 83000

Other trials in France

Argentina3 sites

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1425DES

  • Study site

    Godoy Cruz, Mendoza Province, 5501

  • Study site

    Vicente López, 1638

Other trials in Argentina

Slovakia2 sites

  • Study site

    Bratislava, 821 06

  • Study site

    Prešov, 080 01

Other trials in Slovakia

About this study

Official title: Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.

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.

Read the detailed description

Number of participants with Adverse events will be covered in Adverse Events section.

The statistical analysis tests for the efficacy variables will be performed hierarchically. The comparisons ciprofloxacin DPI vs. pooled placebo (according to statistical analysis plan defined for FDA registration) will be performed in parallel for the regimen 28 days on/off and 14 days on/off.

Conditions
Bronchiectasis
Being tested
Ciprofloxacin DPI (BAYQ3939), Placebo
Keywords
Ciprofloxacin, Dry Powder for Inhalation, Exacerbation, Bronchiectasis
Medical subject headings
Bronchiectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • PlaceboDrug

    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.

Study groups in NCT01764841
Study groupRoleWhat they receive
Ciprofloxacin DPI 28 Days on/off (Cipro 28)ExperimentalParticipants 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).
Receives: Drug: Ciprofloxacin DPI (BAYQ3939)
Ciprofloxacin DPI 14 Days on/off (Cipro 14)ExperimentalParticipants 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).
Receives: Drug: Ciprofloxacin DPI (BAYQ3939)
Placebo 28 Days on/off (Placebo 28)Placebo comparatorParticipants 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).
Receives: Drug: Placebo
Placebo 14 Days on/off (Placebo 14)Placebo comparatorParticipants 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).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to Week 48

Secondary outcomes (7)

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

    For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms over 48 weeks.

    Measured: Up to Week 48

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

    For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and worsening of at least one sign/symptom over 48 weeks.

    Measured: Up to Week 48

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

    Pathogen eradication was defined as a negative culture result for all pre-specified pathogens at end of treatment (week 44 or 46 depending on treatment regimen) that were present in the participant at baseline. There was no imputation for participants who discontinued the study prematurely.

    Measured: End of treatment (Week 44/46)

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

    The SGRQ was a validated, disease-specific instrument that measures health-related quality of life (HRQoL) in adults with chronic obstructive pulmonary disease (COPD) and asthma and was later validated for use in bronchiectasis. The SGRQ covers 3 dimensions: symptoms, activity and impact on daily life. To determine the outcome, a score ranging from 1 to 100 was calculated for each individual domain and for the total score, and smaller scores indicate better health status. For this outcome measure, the symptoms component score was reported.

    Measured: Baseline and end of treatment (Week 44/46)

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

    New pathogens were any of the pre-specified organisms not cultured before start of study medication. There was no imputation for participants who discontinued the study prematurely.

    Measured: End of treatment (Week 44/46)

  6. Mean Change From Baseline in Patient Reported Outcome Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score at End of Treatment (Week 44/46)

    The QoL-B was a disease-specific questionnaire developed for non-Cystic fibrosis Bronchiectasis. It covers 8 dimensions: physical functioning, role functioning, emotional functioning, social functioning, vitality, treatment burden, health perceptions, and respiratory symptoms. Each dimension was scored separately on a scale of 0 to 100, and higher scores represent better outcomes. For this outcome measure, the respiratory symptoms domain score was reported.

    Measured: Baseline and end of treatment (Week 44/46)

  7. Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)

    FEV1 was defined as the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS).

    Measured: Baseline and end of treatment (Week 44/46)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2013 (estimated)
  2. Study start2 May 2013
  3. Primary completion9 Mar 2016
  4. Study completion9 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01764841
Sponsor's protocol ID
15625
Other IDs
2011-004208-39
Acronym
RESPIRE 1
Status last verified
Jan 2018
First submitted
8 Jan 2013
Last updated
24 Jan 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 29371383

  • 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.

    PubMed 28495619

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ciprofloxacin DPI (BAYQ3939) in people with Bronchiectasis, run by Bayer at 151 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in United States, Spain, Germany, Australia, United Kingdom and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Exacerbation Event Within 48 Weeks (time frame: Up to Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01764841, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018.

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