Efficacy of LAMA Added to ICS in Treatment of Asthma (ELITRA)

NCT02296411 | Completed Phase 2 Results

• 2 other identifiers: CCD-05993AB1-022014-001442-16
• Study Type: interventional
• Target: 98
• Locations: 5 countries
• Sites: 28

Brief Summary

Primary objective The primary objective was to evaluate the superiority of CHF 5259 (glycopyrronium bromide \[GB\]) in a pressurised metered dose inhaler (pMDI) (50 μg total daily dose) versus placebo in terms of forced expiratory volume in the first second (FEV1) area under the curve between time 0 and 12 hours (AUC0-12h) normalised by time on Day 42. Key secondary objective The key secondary objective was to evaluate the superiority of CHF 5259 pMDI (50 μg total daily dose) versus placebo in terms of peak FEV1 on Day 42. Secondary objectives The secondary objectives were:

• To evaluate the effect of CHF 5259 pMDI on other lung function parameters and on clinical outcome measures;
• To assess the safety and tolerability of study medications.

Conditions

Asthma

Keywords

Asthma, Anticholinergics; Corticosteroids; CHF 5259 pMDI; Qvar® pMDI add-on therapy

Outcome Measures

Primary Outcomes (2)

• FEV1 AUC0-12h Normalized by Time on Day 42 (ITT Population)

  FEV1 = Forced Expiratory Volume in the first second AUC0-12h = area under the curve between time 0 and 12 hours; assessments were made at 15 min, 30 min, 45 min, 1h, 2h, 3h, 4h, 6h, 8h, 11.5h and 12h post-dose at Day 42 post-dose.

  Day 42

• FEV1 AUC0-12h Normalized by Time on Day 42 (PP Population)

  FEV1 = Forced Expiratory Volume in the first second AUC0-12h = area under the curve between time 0 and 12 hours; assessments were made at 15 min, 30 min, 45 min, 1h, 2h, 3h, 4h, 6h, 8h, 11.5h and 12h post-dose at Day 42 post-dose.

  Day 42

Secondary Outcomes (18)

• Change From Baseline in Peak FEV1 on Day 42 (ITT Population)

  Baseline and Day 42

• Change From Baseline in Peak FEV1 on Day 42 (PP Population)

  Baseline and Day 42

• FEV1 AUC0-12h Normalized by Time on Day 1

  Day 1

• FEV1 AUC0-3h Normalised by Time on Day 1

  Day 1

• FEV1 AUC0-3h Normalised by Time on Day 42

  Day 42

Study Arms (2)

sequence CHF 5259 pMDI - placebo pMDI + Qvar

OTHER

In this sequence, patients received: CHF 5259 pMDI (Active Treatment): CHF 5259 pMDI 12.5 µg as two puffs twice daily (b.i.d.), for a total daily dose of 50 µg, administered via metered dose inhalation of pressurised solution using a standard actuator. Treatment duration: 6 weeks (±2 days). Qvar® pMDI 50 µg or 100 µg b.i.d. was provided as background therapy, with a daily dose ranging from 100 µg to 400 µg. Wash-Out Period (1 Week): Qvar® pMDI 50 µg or 100 µg b.i.d., administered via metered dose inhalation of pressurised solution, with a daily dose ranging from 100 µg to 400 µg. Placebo of CHF 5259 pMDI (Control Treatment): A matched placebo for CHF 5259 pMDI, administered via metered dose inhalation of pressurised solution using a standard actuator. Treatment duration: 6 weeks (±2 days). Qvar® pMDI 50 µg or 100 µg b.i.d. was provided as background therapy, with a daily dose ranging from 100 µg to 400 µg.

Drug: CHF 5259 12.5 µg + Qvar; Drug: CHF 5259 placebo + Qvar

sequence placebo pMDI - CHF 5259 pMDI + Qvar

OTHER

In this sequence, patients received: Placebo of CHF 5259 pMDI (Control Treatment): A matched placebo for CHF 5259 pMDI, administered via metered dose inhalation using a standard actuator for 6 weeks (±2 days). Qvar® pMDI 50 µg or 100 µg b.i.d. was provided as background therapy, with a daily dose ranging from 100 µg to 400 µg. Wash-Out Period (1 Week): Qvar® pMDI 50 µg or 100 µg b.i.d., administered via metered dose inhalation using a standard actuator, with a daily dose ranging from 100 µg to 400 µg. CHF 5259 pMDI (Active Treatment): CHF 5259 pMDI 12.5 µg as two puffs twice daily (b.i.d.), for a total daily dose of 50 µg, administered via metered dose inhalation using a standard actuator for 6 weeks (±2 days). Qvar® pMDI 50 µg or 100 µg b.i.d. was provided as background therapy, with a daily dose ranging from 100 µg to 400 µg.

Drug: CHF 5259 12.5 µg + Qvar; Drug: CHF 5259 placebo + Qvar

Interventions

CHF 5259 12.5 µg + Qvar DRUG

comparison of CHF 5259 versus placebo over 2 treatment periods of 6 weeks ± 2 days

Also known as: glycopyrrolate bromide

sequence CHF 5259 pMDI - placebo pMDI + Qvar; sequence placebo pMDI - CHF 5259 pMDI + Qvar

CHF 5259 placebo + Qvar DRUG

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

Also known as: Placebo

sequence CHF 5259 pMDI - placebo pMDI + Qvar; sequence placebo pMDI - CHF 5259 pMDI + Qvar

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient's written informed consent obtained prior to any study related procedures;
• Male or female patients aged ≥18 and ≤75 years;
• History of asthma ≥5 year and diagnosed before the age of 40 years;
• Patients with uncontrolled asthma on low medium doses of ICS (200 - 1000 μg daily dose BDP non-extrafine or estimated clinical comparable dose) at a stable dose for at least 4 weeks prior to Screening visit;
• Patients with a pre bronchodilator FEV1 ≥40% and \<90% of their predicted normal value, after appropriate washout from bronchodilators, at Screening visit and the end of the run in period;
• Patients with a positive response to the reversibility test at Screening visit within 30 minutes after administration of 400 μg of salbutamol pMDI, defined as ΔFEV1 ≥12% and ≥200 mL over baseline; Note: In case this reversibility threshold was not met, the test could have been performed once before randomisation.
• Patients with uncontrolled asthma evidenced by a score at the Asthma Control Questionnaire® (ACQ) ≥1.5 (criterion had to be met at Screening visit and the end of the run in period);

You may not qualify if:

• Inability to carry out pulmonary lung function testing, to comply with study procedures or with study medication intake;
• History of near fatal asthma or of a past hospitalisation for asthma in intensive care unit or of frequent exacerbations in the last year which, in the judgement of the Investigator, may have placed the patient at risk;
• Hospitalisation, emergency room admission or use of systemic corticosteroids for asthma exacerbation in the 4 weeks prior to Screening visit or during the run-in period;
• Lower respiratory tract infection in the 4 weeks before Screening visit or during the run-in period;
• Patients who were in current therapy for gastroesophageal reflux disease (GERD) or patients with a medical history of GERD that led to asthma symptoms;
• Patients with a seasonal worsening of asthma and who were not able to complete the study outside the relevant allergen season;
• History of cystic fibrosis, bronchiectasis or alpha 1 antitrypsin deficiency, bronco carcinoma, lung carcinoma or any other significant lung disease which may have interfered with data evaluation;
• Patients with a medical history or current diagnosis of COPD as defined by the Global Initiative for chronic obstructive lung disease (GOLD) guidelines (2014);
• Current smokers or ex-smokers with total cumulative exposure equal or more than 10 pack years or having stopped smoking one year or less prior to Screening visit;
• Any change in dose, schedule or formulation of ICS in the 4 weeks prior to Screening visit;
• Patient had used any of the following treatments 4 weeks before Screening visit: inhaled LABAs, inhaled LAMAs, inhaled ICS/LABA fixed combinations, theophylline,leukotriene modifiers, cromolyn sodium, nedocromil sodium, systemic anticholinergics, systemic corticosteroids (12 weeks for slow release corticosteroids);
• Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) unless are using at least one or more of the following reliable methods of contraception:
• Placement of an intrauterine device or intrauterine system;
• Hormonal contraception (implantable, injectable, patch, oral);
• Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical vaults/caps) with spermicidal foam/gel/film/cream/suppository;

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (28)

Chiesi Clinical Trial Site 0107

Rousse, 7002, Bulgaria

Location

Chiesi Clinical Trial Site 0106

Sevlievo, 5400, Bulgaria

Location

Chiesi Clinical Trial Site 0101

Sofia, 1000, Bulgaria

Location

Chiesi Clinical Trial Site 0109

Sofia, 1336, Bulgaria

Location

Chiesi Clinical Trial Site 0108

Sofia, 1407, Bulgaria

Location

Chiesi Clinical Trial Site 0102

Sofia, 1431, Bulgaria

Location

Chiesi Clinical Trial Site 0103

Sofia, 1431, Bulgaria

Location

Chiesi Clinical Trial Site 0201

Berlin, D-12165, Germany

Location

Chiesi Clinical Trial Site 0203

Leipzig, 04207, Germany

Location

Chiesi Clinical Trial Site 0202

Leipzig, 04357, Germany

Location

Chiesi Clinical Trial Site 0206

Magdeburg, 39112, Germany

Location

Chiesi Clinical Trial Site 0207

Radebeul, 01445, Germany

Location

Chiesi Clinical Trial Site 0208

Witten, 58452, Germany

Location

Chiesi Clinical Trial Site 0306

Brescia, 25123, Italy

Location

Chiesi Clinical Trial Site 0301

Pisa, 56124, Italy

Location

Chiesi Clinical Trial Site 0304

Pisa, 56124, Italy

Location

Chiesi Clinical Trial Site 0303

Pordenone, 33170, Italy

Location

Chiesi Clinical Trial Site 0404

Assen, 9401 RK, Netherlands

Location

Chiesi Clinical Trial Site 0405

Helmond, 5707 HA, Netherlands

Location

Chiesi Clinical Trial Site 0501

Bialystok, 15-010, Poland

Location

Chiesi Clinical Trial Site 0502

Bialystok, 15-351, Poland

Location

Chiesi Clinical Trial Site 0503

Elblag, 82-300, Poland

Location

Chiesi Clinical Trial Site 0507

Krakow, 30-349, Poland

Location

Chiesi Clinical Trial Site 0504

Krakow, 31-011, Poland

Location

Chiesi Clinical Trial Site 0512

Lodz, 90-141, Poland

Location

Chiesi Clinical Trial Site 0510

Lodz, 90-252, Poland

Location

Chiesi Clinical Trial Site 0505

Wroclaw, 53-310, Poland

Location

Chiesi Clinical Trial Site 0506

Zgierz, 95-100, Poland

Location

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone; Glycopyrrolate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Trial INFO
• Organization: Chiesi Farmaceutici S.p.A.

clinicaltrials_info@chiesi.com

+39 0521 2791

Study Officials

• prof. Pierluigi Paggiaro, MD

  Dip. Cardio-Toracico e Vascolare Malattie dell'Apparato respiratorio, Ospedale Cisanello, Pisa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 20, 2014
• Study Start: November 21, 2014
• Primary Completion: August 13, 2015
• Study Completion: August 13, 2015
• Last Updated: April 22, 2026
• Results First Posted: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

Locations

DE (6); NL (2); IT (4); PL (9); BU (7)