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CompletedNCT01197469Updated Nov 6, 2012

Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hypertension?

A Phase 2 interventional study of Tadalafil and Placebo in Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension, sponsored by University of Dundee. Completed at 1 site in United Kingdom. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-11-06.

Sponsored by University of Dundee · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
35 Years to 85 Years
Sex
All
01

Study summary

The investigators hypothesise that phosphodiesterase 5A inhibitors will improve exercise capacity in those with Chronic Obstructive Pulmonary Disease and secondary pulmonary hypertension.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Pulmonary Hypertension

Keywords

  • Secondary Pulmonary Hypertension
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 120 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

University of Dundee is the lead sponsor of 111 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • COPD
  • Forced expiratory volume in 1 second (FEV1) \<80% (FEV1/FVC \<0.70)
  • Right ventricular systolic pressure (RVSP) > 30 mmHg or Pulmonary Acceleration time \<120 ms

Exclusion criteria

Exclusion Criteria:

  • Pulmonary stenosis or echo left ventricular outflow tract obstruction
  • Left ventricular ejection fraction \< 45%
  • Patients taking nitrates, nicorandil or doxazosin.

  • Drug contraindications:

    • Systolic Blood Pressure \<90 mmHg
    • recent stroke
    • unstable angina
    • past history of non arteritic anterior ischaemic optic neuropathy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
120 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

  • Active comparator
    Tadalafil

    Drug: Tadalafil

Interventions

  • DrugTadalafil

    Tadalafil 10mg once daily for 3 months

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. 6 minute walking distance

    The investigators will perform a baseline 6 minute walking distance (0 months) and repeat the measure at 2 months and finally at 3 months

    Time frame: 3 months

Secondary outcomes

  1. Quality of Life

    The investigators will measure baseline quality of life (0 months) using St George's Respiratory Questionnaire, SF-36v2, Minnesota Heart Failure Questionnaire. These questionnaires will be repeated at 2 and 3 months (final measurement).

    Time frame: 3 months

  2. B- Natriuretic Peptide (BNP)

    Will be measured at 0, 2 and 3 months

    Time frame: 3 months

  3. Diffusion lung capacity for carbon monoxide (DLCO)

    Will be measured at 0 and 3 months

    Time frame: 3 months

  4. Echocardiographic measurements

    Will be measured at 0 and 3 months

    Time frame: 3 months

07

Study locations

1 site
  • University of Dundee
    Dundee, Tayside DD1 9SY, United Kingdom
08

References and documents

Publications

  • Goudie AR, Lipworth BJ, Hopkinson PJ, Wei L, Struthers AD. Tadalafil in patients with chronic obstructive pulmonary disease: a randomised, double-blind, parallel-group, placebo-controlled trial. Lancet Respir Med. 2014 Apr;2(4):293-300. doi: 10.1016/S2213-2600(14)70013-X. Epub 2014 Mar 5. PubMed 24717626 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01197469
Lead sponsor
University of Dundee
Collaborators
Chief Scientist Office of the Scottish Government, NHS Tayside, NHS Fife
Responsible party
A. D. Struthers (Chief Investigator, University of Dundee) — Principal investigator
First posted
Sep 9, 2010
Start date
Sep 2010
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Nov 6, 2012

Study contacts

Allan Struthers, MBChB
principal investigator · University of Dundee

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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