A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to investigate the effect of Formoterol HFA-pMDI versus Salmeterol HFA-pMDI on small airways physiological parameters in COPD patients. IMPERIAL Study - IMPERIAL Study

Phase 1

• Conditions: COPD; MedDRA version: 14.0 Level: LLT Classification code 10009032 Term: Chronic obstructive lung disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2008-008656-16-GB
• Lead Sponsor: Chiesi Farmaceutici SpA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-01
• Study Completion: 2012-09-17
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. Subject’s written informed consent obtained prior to any
study-related procedures
2. Male and female outpatients, aged = 40 years
3. Patients with a clinical diagnosis of COPD (according
to GOLD guidelines)
4. Post bronchodilator (to salbutamol 400 micrograms inhalation pMDI as per GOLD guidelines) FEV1 between 30% and 80% predicted values (30% = FEV1 < 80%) documented at screening visit [=Stage 2 and Stage 3 GOLD criteria]
5. Post-bronchodilator (to salbutamol 400 micrograms inhalation pMDI as per GOLD guidelines) FEV1/FVC < 0.7 (absolute value) documented at screening visit
6. Ability to be trained to use the pMDI device correctly.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Current or past diagnosis of asthma
2. Positive FEV1 reversibility test: ?FEV1 30 minutes following inhalation of 400 µg of salbutamol pMDI greater than 200 mL and 12% above the prebronchodilator
FEV1
3. History of any chronic respiratory diseases other than COPD
4. History of another medical condition, which in the opinion of the Unit Physician, contraindicates his/her participation in the study.
5. Clinical evidence of heart failure (NYHA class III-IV)
6. Unstable respiratory disease in the last four weeks prior to the screening visit (indicated by any change in their maintenance inhaled therapy or who have had a
lower respiratory tract infection in the previous four weeks)
7. Evidence of a respiratory exacerbation requiring emergency room treatment and/or hospitalisation within four weeks before screening.
8. Use of systemic (oral or intravenous) steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 12 months
9. Participants with a known or suspected allergy, sensitivity or intolerance to the study drugs or to long acting beta agonists, will be excluded from the study.
10. Patient with a contraindication to taking an inhaled long-acting beta-agonists, listed in the British National Formulary (BNF)
11. Patients treated with beta-blockers in the week preceding the screening visit and during the study period
12. Females who are pregnant or lactating or are likely to become pregnant during the trial. Women of childbearing potential may be included in the study if, in the opinion of the investigator, they are taking adequate contraceptive precautions.
13. Patients who have evidence of alcohol or substance
abuse
14. Participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified