RecruitingPhase 2ACTRN12612001239853

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.


Sponsor

Shahid Beheshti University, M.C.

Enrollment

30 participants

Start Date

Feb 27, 2012

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and females

Inclusion Criteria1

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

Exclusion Criteria1

  • 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 .

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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 w

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.


Locations(1)

Tehran, Iran, Islamic Republic Of

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ACTRN12612001239853