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Efficacy of LAMA Added to ICS in Treatment of Asthma

NCT ID: NCT02296411

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-08-31

Brief Summary

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The purpose of this study is to evaluate the superiority of the glycopyrrolate bromide (CHF 5259 pMDI) versus placebo on top of QVAR® pMDI, in terms of lung functions parameters, as well as to assess its safety.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CHF 5259 12.5 µg

CHF 5259 12.5 µg: 2 inhalations bid (50µg daily dose)

Group Type EXPERIMENTAL

CHF 5259 12.5 µg

Intervention Type DRUG

comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks

CHF 5259 placebo

CHF 5259 placebo: 2 inhalations bid

Group Type PLACEBO_COMPARATOR

CHF 5259 placebo

Intervention Type DRUG

comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks

Interventions

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CHF 5259 12.5 µg

comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks

Intervention Type DRUG

CHF 5259 placebo

comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks

Intervention Type DRUG

Other Intervention Names

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glycopyrrolate bromide Placebo

Eligibility Criteria

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Inclusion Criteria

* History of asthma ≥ 5 years and diagnosed before 40 years old
* Uncontrolled asthma on low-medium doses of Inhaled CorticoSteroid (ICS) with ACQ (Asthma Control Questionnaire) ≥1.5
* Pre-bronchodilator FEV1 ≥40% and \<90% of their predicted normal value
* Positive reversibility test

Exclusion Criteria

* Pregnant or lactating women
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* Patients treated for asthma exacerbation 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chiesi Clinical Trial Site 0107

Rousse, , Bulgaria

Site Status

Chiesi Clinical Trial Site 0106

Sevlievo, , Bulgaria

Site Status

Chiesi Clinical Trial Site 0101

Sofia, , Bulgaria

Site Status

Chiesi Clinical Trial Site 0109

Sofia, , Bulgaria

Site Status

Chiesi Clinical Trial Site 0108

Sofia, , Bulgaria

Site Status

Chiesi Clinical Trial Site 0102

Sofia, , Bulgaria

Site Status

Chiesi Clinical Trial Site 0103

Sofia, , Bulgaria

Site Status

Chiesi Clinical Trial Site 0201

Berlin, , Germany

Site Status

Chiesi Clinical Trial Site 0203

Leipzig, , Germany

Site Status

Chiesi Clinical Trial Site 0202

Leipzig, , Germany

Site Status

Chiesi Clinical Trial Site 0206

Magdeburg, , Germany

Site Status

Chiesi Clinical Trial Site 0207

Radebeul, , Germany

Site Status

Chiesi Clinical Trial Site 0208

Witten, , Germany

Site Status

Chiesi Clinical Trial Site 0306

Brescia, , Italy

Site Status

Chiesi Clinical Trial Site 0301

Pisa, , Italy

Site Status

Chiesi Clinical Trial Site 0304

Pisa, , Italy

Site Status

Chiesi Clinical Trial Site 0303

Pordenone, , Italy

Site Status

Chiesi Clinical Trial Site 0404

Assen, , Netherlands

Site Status

Chiesi Clinical Trial Site 0405

Helmond, , Netherlands

Site Status

Chiesi Clinical Trial Site 0501

Bialystok, , Poland

Site Status

Chiesi Clinical Trial Site 0502

Bialystok, , Poland

Site Status

Chiesi Clinical Trial Site 0503

Elblag, , Poland

Site Status

Chiesi Clinical Trial Site 0507

Krakow, , Poland

Site Status

Chiesi Clinical Trial Site 0504

Krakow, , Poland

Site Status

Chiesi Clinical Trial Site 0512

Lodz, , Poland

Site Status

Chiesi Clinical Trial Site 0510

Lodz, , Poland

Site Status

Chiesi Clinical Trial Site 0505

Wroclaw, , Poland

Site Status

Chiesi Clinical Trial Site 0506

Zgierz, , Poland

Site Status

Countries

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Bulgaria Germany Italy Netherlands Poland

Related Links

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https://www.clinicaltrialsregister.eu/ctr-search/search?query=2014-001442-16

Study Record on EU Clinical Trials Register including results

Other Identifiers

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2014-001442-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CCD-05993AB1-02

Identifier Type: -

Identifier Source: org_study_id

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