Skip to main content
OpenTrials
Completed

NCT Number: NCT02106832

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Placebo

Drug

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

Primary outcomes

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

    Time frame: Up to Week 48

    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.

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

    Time frame: Up to Week 48

    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.

Secondary outcomes

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

    Time frame: Up to Week 48

    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.

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

    Time frame: Up to Week 48

    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.

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

    Time frame: 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.

  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)

    Time frame: Baseline and 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.

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

    Time frame: 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.

  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)

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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).

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Novartis

Registry information

Official study 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.

Acronym: RESPIRE 2

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 8, 2014
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.