NCT00706446.

Methods	Study design: RCT Study grouping: parallel group Open label: yes Cluster RCT: no
Participants	Baseline characteristics No full text available and no results posted on clinicaltrials.gov. The following baseline characteristics were not available for either group N umber randomised Number completed Mean age % Male % Predicted FEV1 % White Duration of asthma Inclusion criteria: clinical history consistent with asthma; current prescription for a LABA, either alone or in combination with an ICS; informed consent; non‐smoker (total lifetime smoking history < 10 pack‐years); no known contraindication to inhaled tiotropium (e.g. narrow angle glaucoma, history of bladder neck obstruction or significant symptoms related to prostatic hypertrophy) Exclusion criteria: lung disease other than asthma; established or suspected diagnosis of vocal cord dysfunction; significant unstable medical illness (other than asthma); history of life‐threatening asthma within 5 years; history of respiratory tract infection within 4 weeks; hyposensitisation therapy other than an established maintenance regimen; current use of, or allergy to, tiotropium; pregnancy or lactation; if able to bear children, not using acceptable contraception; inability to use inhalers; inability to participate over the 1‐year period
Interventions	Intervention characteristics LAMA add‐on ICS type/dose: ICS at variable dosing based on participant's prior ICS dosing and treating physician's judgement Add‐on type/dose: tiotropium bromide 1 inhalation a day for 1 year Co‐medications: as above for ICS Type of inhaler: not stated Duration of treatment: 1 year (planned) LABA add‐on ICS type/dose: ICS at variable dosing based on participant's prior ICS dosing and treating physician's judgement Add‐on type/dose: salmeterol Diskus 1 puff twice a day or formoterol inhaler 2 puffs twice a day for 1 year, depending on which medication the participant was on before the start of the trial Co‐medications: as above for ICS Type of inhaler: Diskus for salmeterol Duration of treatment: 1 year (planned)
Outcomes	No full text available and no results posted on clinicaltrials.gov
Identification	Sponsorship source: Brigham and Women's Hospital with collaboration from Harvard Clinical Research Institute and Massachusetts General Hospital Country: USA Setting: 2 centres Comments: study terminated Authors name: Elliot Israel, MD Institution: Brigham and Women's Hospital Email: eisrael@partners.org Address: Brigham and Women's Hospital Respiratory, 75 Francis St, Boston MA 02115
Notes	Study terminated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Allocation was randomised ‐ no details provided
Allocation concealment (selection bias)	Unclear risk	No details provided
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open label
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open label
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not applicable, study did not complete
Selective reporting (reporting bias)	Unclear risk	Study did not complete and hence no outcomes are reported. No interim results reported, or information regarding the decision to terminate
Other bias	High risk	Study terminated prior to completion