Beta-Blocker Therapy in Moderate to Severe COPD

Evaluation of effects of chronic dose exposure to cardioselective and non-cardioselective beta blockers on measures of cardiopulmonary function in moderate to severe COPD. - Beta Blocker therapy in moderate to severe COPD. ANDA2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006008-11-GB

Enrollment

Registered

2012-07-27

Start date

2012-08-22

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 14.1 Level: LLT Classification code 10009026 Term: Chronic obstructive airways disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Fostair 100/6 Product Name: Fostair 100/6 (Beclometasone/Formoterol) Inhalation solution Pharmaceutical Form: Inhalation solution INN or Pro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male and female volunteers aged 40-80 years with stable moderate to severe COPD (GOLD stage 2&3). • FEV1 30-80% predicted and FEV1/FVC ratio =65 years) yes F.1.3.1 Number of subjects for this age range 9

Exclusion criteria

Exclusion criteria: • Uncontrolled symptoms of COPD. • A COPD exacerbation requiring systemic steroid therapy within 3 months prior to study commencement. • Use of domiciliary oxygen. • History of other primary obstructive lung disease including asthma or bronchiectasis. • History of unstable angina, uncontrolled hypertension or heart failure NYHA class 3-4. • Overt clinical signs of right heart failure. • Average resting systolic BP<110mmHg or average resting HR<60bpm. • Pregnancy or lactation. • Known or suspected sensitivity to / intolerance of IMP. • Inability to comply with compulsory aspects of protocol. • Any degree of heart block. • Concomitant prescription of beta-blockers, rate-limiting calcium channel blockers, digoxin or amiodarone. • Any clinically significant medical condition that may endanger the health or safety of the participant, or jeopardise the protocol. • Participation in another trial within the previous 30 days.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effects on measures of lung and heart function of two different beta blockers - one that acts mainly on the heart and the other that acts on both the heart and lungs - after chronic dosing.; Secondary Objective: To assess how beta blockers interact with standard COPD inhaler treatment. To assess how well beta blockers are tolerated in COPD using gradually increasing doses over several weeks. To assess what protection is given by the inhaler Tiotropium against worsening of lung function in the early stages of the beta blocker treatment. ;Primary end point(s): The null hypothesis proposed is there is no difference between cardioselective (bisoprolol) and non-cardioselective (carvedilol) beta blockade, with chronic dosing, in terms of change in airway resistance at 5Hz (R5), using Impulse Oscillometry, from baseline.;Timepoint(s) of evaluation of this end point: At baseline and end of 4th, 5th and 6th weeks of each (of two) treatment periods.	—

Measure

Time frame

Main Objective: To assess the effects on measures of lung and heart function of two different beta blockers - one that acts mainly on the heart and the other that acts on both the heart and lungs - after chronic dosing.; Secondary Objective: To assess how beta blockers interact with standard COPD inhaler treatment. To assess how well beta blockers are tolerated in COPD using gradually increasing doses over several weeks. To assess what protection is given by the inhaler Tiotropium against worsening of lung function in the early stages of the beta blocker treatment. ;Primary end point(s): The null hypothesis proposed is there is no difference between cardioselective (bisoprolol) and non-cardioselective (carvedilol) beta blockade, with chronic dosing, in terms of change in airway resistance at 5Hz (R5), using Impulse Oscillometry, from baseline.;Timepoint(s) of evaluation of this end point: At baseline and end of 4th, 5th and 6th weeks of each (of two) treatment periods.

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Secondary

Measure	Time frame
Secondary end point(s): Remaining IOS variables (R20, X5, AX, RF); Spirometry (FEV1, FVC, slow VC, FEF25-75); Oxygen saturations; Heart rate; Blood pressure; ECG parameters; 6min walk test (where physically possible); Echocardiogram parameters (where technically possible); Domiciliary FEV1, symptoms, reliever use, 02 sats and HR; SGRQ; Serum BNP, Aldosterone, Angiotensin II, BDNF, Potassium.;Timepoint(s) of evaluation of this end point: At baseline and end of 4th, 5th and 6th weeks of each (of two) treatment periods.	—

Measure

Time frame

Secondary end point(s): Remaining IOS variables (R20, X5, AX, RF); Spirometry (FEV1, FVC, slow VC, FEF25-75); Oxygen saturations; Heart rate; Blood pressure; ECG parameters; 6min walk test (where physically possible); Echocardiogram parameters (where technically possible); Domiciliary FEV1, symptoms, reliever use, 02 sats and HR; SGRQ; Serum BNP, Aldosterone, Angiotensin II, BDNF, Potassium.;Timepoint(s) of evaluation of this end point: At baseline and end of 4th, 5th and 6th weeks of each (of two) treatment periods.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026