Study C

A randomised international multi-centre trial for the evaluation of a four-drug fixed dose combined tablet daily in the initial phase (2 months) of chemotherapy followed by a two-drug fixed dose combined tablet three times a week in the continuation phase (4 months) for the treatment of pulmonary tuberculosis.

What is the best way to give treatment for tuberculosis in the lungs?

What was this study about?

This research study tested a tablet for the treatment of tuberculosis of the lungs (pulmonary TB). This tablet combined the four TB medicines (Pyrazinamide, Ethambutol, Rifampicin and Isoniazid) given during the first two months of treatment all in one tablet.

This trial tested whether it is better for people to take the tablet which combines all of the usual TB medicines, or as a number of separate tablets. We checked which treatment:

  • Worked best
  • Had the least side effects
  • Was most acceptable to the people who had to take them

Participants were randomised into one of two groups; in one group they were given tablets in which all four drugs were combined into one tablet, in the other group they were given their drugs as separate tablets.

What difference did this study make?

The results for the 4-drug combination tablet (FDC) for treatment of tuberculosis satisfied the specified non-inferiority criteria when compared to administration of separate drugs in 2 of 3 analyses.  There were no safety concerns.

Although non-inferiority was not fully demonstrated the  use of FDCs is to be preferred to separate drug-formulations because of potential advantages such as a considerably lower pill burden in the intensive phase and elimination of the risk of developing drug-resistance due to selective drug use.

Type of study

Randomised trial

Contact details

Who funded the study?

This trial was funded by the United States Government’s Aid for International Development (USAID).

When did it take place?

This study took place between 2003 and 2009.  The final report was in 2014.

Where did it take place?

In sites across Africa, Asia and South America.

Who was included?

1707 patients with pulmonary TB were recruited.