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Trial record 28 of 186 for:    GLYCOPYRROLATE

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.

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: CHF 5259 plus Foster 100/6 µg Drug: Foster 100/6 µg Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: CHF 5259 25 µg plus Foster 100/6 µg 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

Experimental: CHF 5259 50 µg plus Foster 100/6 µg 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

Experimental: CHF 5259 100 µg plus Foster 100/6 µg 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

Active Comparator: Foster 100/6 µg 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




Primary Outcome Measures :
  1. FEV1 AUC0-12h normalised by time on Day 42 [ Time Frame: Day 42 ]

Secondary Outcome Measures :
  1. Peak FEV1 on Day 42 [ Time Frame: Day 42 ]
  2. Adverse Events and Adverse Drug Reactions [ Time Frame: Up at Week 24 (study end) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127866


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Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: Dave Singh, MD University Hospital of South Manchester, MANCHESTER M23 9 QZ, UK

Additional Information:
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Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT02127866     History of Changes
Other Study ID Numbers: CCD-1206-PR-0088
2013-003043-36 ( EudraCT Number )
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Keywords provided by Chiesi Farmaceutici S.p.A.:
Asthma, anticholinergics
Additional relevant MeSH terms:
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Glycopyrrolate
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Beclomethasone
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Anti-Inflammatory Agents
Glucocorticoids