Inhaled verapamil in patients with pulmonary hypertension secondary to chronic obstructive pulmonary disease (COPD)

A placebo controlled clinical trial on the efficacy of inhaled verapamil 10 mg stat administration in patients with chronic obstructive pulmonary disease (COPD) and pulmonary arterial pressure(PAP)>45 mmHg.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001239853

Acronym

IVPHC

Enrollment

Registered

2012-11-23

Start date

2012-02-27

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

We could not find any study that has examined the use of verapamil in PH secondary to COPD. The proposed study will provide scientifically valid data to date on whether nebulised verapamil (10 mg) is effective in these cases or not.

Interventions

ARM 1:(a) Intervention group - nebulised verapamil ( 4ml,10mg) (the dosing form that exist in the market ,is 2.5 mg/ml as an injectable solution) once only. ARM 2:(b)Placebo group (4ml of distilled water) once only.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Patients with pulmonary arterial pressure (PAP)>45mmHg secondary to chronic obstructive pulmonary disease (COPD) and normal ejection fraction (EF) (> 40%).

Exclusion criteria

1.Pregnancy 2.Patients with previous known hypersensitivity to verapamil (any formulation or route of administration) 3. Patients with sepsis 4. Patients with dysrythmia or heart block (second degree and third degree). 5.Patients with COPD exacerbation 6.Any contraindication for verapamil 7.Presence of an end stage disease (cardiac, renal and hepatic) 8.Patients receiving another calcium channel blocker (CCB), sildenafil and bosentan .

Outcome results