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Triple in Asthma Dose Finding (Triskel)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02127866
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Tracking Information
First Submitted Date  ICMJE April 9, 2014
First Posted Date  ICMJE May 1, 2014
Last Update Posted Date March 29, 2017
Study Start Date  ICMJE April 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
FEV1 AUC0-12h normalised by time on Day 42 [ Time Frame: Day 42 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02127866 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
  • Peak FEV1 on Day 42 [ Time Frame: Day 42 ]
  • Adverse Events and Adverse Drug Reactions [ Time Frame: Up at Week 24 (study end) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Triple in Asthma Dose Finding
Official Title  ICMJE A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 3-WAY CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A FREE COMBINATION OF 3 DOSES OF CHF 5259 (GLYCOPYRROLATE) PLUS FOSTER® 100/6 µg (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL) IN A METERED DOSE INHALER FOR THE TREATMENT OF PATIENTS WITH UNCONTROLLED ASTHMA UNDER MEDIUM DOSES OF INHALED CORTICOSTEROIDS PLUS LONG-ACTING β2-AGONISTS
Brief Summary The purpose of this study is to determine the optimal dose of CHF 5259 (glycopyrrolate bromide) on top of Foster which provides the optimal additive bronchodilator effect to asthmatic patients whose symptoms are uncontrolled with medium dose of inhaled corticosteroids plus long acting beta2 agonists.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: CHF 5259 plus Foster 100/6 µg
    Comparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)
    Other Name: glycopyrrolate + beclometasone/formoterol
  • Drug: Foster 100/6 µg

    Active comparator

    Comparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)

    Other Name: beclometasone dipropionate/formoterol
Study Arms  ICMJE
  • Experimental: CHF 5259 25 µg plus Foster 100/6 µg
    Intervention: Drug: CHF 5259 plus Foster 100/6 µg
  • Experimental: CHF 5259 50 µg plus Foster 100/6 µg
    Intervention: Drug: CHF 5259 plus Foster 100/6 µg
  • Experimental: CHF 5259 100 µg plus Foster 100/6 µg
    Intervention: Drug: CHF 5259 plus Foster 100/6 µg
  • Active Comparator: Foster 100/6 µg
    Intervention: Drug: Foster 100/6 µg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2014)
211
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2014)
220
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients aged >=18 years
  • Uncontrolled asthma on medium doses of ICS+LABA with ACQ >=1.5
  • Pre-bronchodilator FEV1 ≥40% and <80% of their predicted normal value

Exclusion Criteria:

  • Pregnant or lactating women
  • Diagnosis of COPD
  • Patients treated for asthma exacerbations in the 4 weeks prior to study entry
  • Patients who are in therapy for gastroesophageal reflux disease
  • Patients who have a clinically significant cardiovascular condition
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Germany,   Hungary,   Italy,   Poland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02127866
Other Study ID Numbers  ICMJE CCD-1206-PR-0088
2013-003043-36 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chiesi Farmaceutici S.p.A.
Study Sponsor  ICMJE Chiesi Farmaceutici S.p.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dave Singh, MD University Hospital of South Manchester, MANCHESTER M23 9 QZ, UK
PRS Account Chiesi Farmaceutici S.p.A.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP